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2019.07.16 US Hemp Roundtable FDA Comments

"CBD is Safe. Here’s the Data" The US Hemp Roundtable, an organization we support that fights on our behalf for fair hemp laws & regulation, just made the above statement to the FDA in hopes of speeding up their ponderous deliberation on creating CBD product guidlines. The statement was made along with a long letter to the FDA illustrating scientific evidence around the safety of CBD.

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100% found this document useful (1 vote)

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2019.07.16 US Hemp Roundtable FDA Comments

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e: info@hempsupporter.

com
p: 502.319.2358
u: www.hempsupporter.com

Board of Directors
American Shaman
Ananda Professional July 16, 2019
Barlean’s
Bluebird Botanicals
CBDistillery Division of Dockets Management (HFA-305)
CBD USA Grown
CV Sciences Food and Drug Administration
CW Hemp
Elixinol Department of Health and Human Services
Front Range Biosciences 5630 Fishers Lane, Room 1061
Garden of Life
GenCanna Rockville, MD 20852
Hemp Industries Association
HempFusion
HempWorx RE: FDA's Scientific Data and Information about Products Containing Cannabis
Koi CBD
Lazarus Naturals or Cannabis-Derived Compounds; Public Hearing; Request for Comments. 84 Fed.
Lord Jones
Medterra Reg. 12969 - 12975 (April 3, 2019). Docket No. FDA-2019-N-1482.
Mile High Labs
Pet Releaf
Presence Marketing
Pyxus
Recess The U.S. Hemp Roundtable (“the Roundtable”) appreciates the opportunity to
Rocky Mountain High Brands
Turning Point Brands
provide comments to FDA in response to its request for scientific data and information
Village Farms
Williams Ranch Co.
about the safety, manufacturing, product quality, marketing, labeling, and sale of
Zilis products containing cannabis or cannabis-derived compounds. The Roundtable is the
Members
Abacus Health Products hemp industry’s leading business advocacy organization, committed to fostering
AgTech Scientific
Alliant Insurance Services regulatory discussions about hemp products and building an accountable industry. With
American Herbal Products
Association
members from more than seventy firms from across the country, the Roundtable’s Board
Atalo Holdings
Baron Todd
of Directors and members constitute many of the hemp industry’s largest businesses. We
BMJ Group
Botanacor
are also closely aligned with the Hemp Industries Association (“HIA”), the industry’s
CBDmd leading trade association and grassroots force. Together with HIA, the Roundtable has
CBD Snapshot
Cream worked toward fostering increased accountability for the hemp-derived consumer product
Criticality
ECS Distribution industry by providing high standards, best practices and self-regulation, giving
Elemental Processing
Esquire Bank confidence to consumers and law enforcement that hemp products are safe and legal.
Eurofins Food Integrity and
Innovation
Friends of Hemp
FSOIL Although FDA’s request for comments broadly references “cannabis” and
Gotham Green Partners
Harrod’s Creek Farm “cannabis-derived compounds” our comments are limited to hemp extracts and
Hemp Today
Highland Laboratories
constituents such as cannabidiol (“CBD”), which may be used as ingredients in products
Lucky’s Market
MJNA Group
intended for use in humans and animals, including supplements, foods, and cosmetic
New West Genetics products. The Roundtable supports FDA’s efforts to ensure that products containing
Nutraceutical Corporation
Phivida Organics hemp and CBD are manufactured in a safe, consistent manner and accurately labeled.
Pinnacle CBD
Prana Principle We also appreciate FDA’s willingness to work with stakeholders to develop an
QC Infusion
Realm of Caring appropriate framework for hemp-derived CBD as a dietary supplement and food
Reliva
Restorative Botanicals ingredient. We believe Congress clearly intended to have CBD and hemp products
Sagely Naturals
Stillwater Ingredients
Sozo Hemp
Sunflora, Inc.
ValidCare
Virginia Industrial Hemp Coalition
VitaGenne
Vote Hemp
VYBES Paid for by U.S. Hemp Roundtable, Inc., an independent, nonprofit organization exempt from federal taxation
Winged Nutrition under section 501(c)(4) of the Internal Revenue Code. Contributions to U.S. Hemp Roundtable, Inc. are not
Zelios
deductible as charitable donations for federal income tax purposes. 250 West Main Street, Suite 2800, Lexington,
KY 40507.
FDA Docket No. 2019-N-1482
July 16, 2019
Page 2

available to consumers in a wide range of product categories – including food and dietary supplements – when
it passed the Agriculture Improvement Act of 2018. 1

We also believe that FDA has all the tools necessary to expeditiously issue a rule allowing CBD in foods
and dietary supplements. The Federal Food, Drug, and Cosmetic Act (“FD&C Act”), along with FDA’s robust
implementing regulations, provide the necessary framework to ensure that hemp-derived products are
appropriately manufactured, labeled, and marketed, and safe for consumers. This framework provides the
flexibility necessary to accommodate the different formulations of hemp-derived ingredients on the market
while also allowing for continued innovation and scientific advances. However, we believe FDA must act
swiftly as a growing number of hemp-derived CBD products on the market, whether labeled as dietary
supplements, food or cosmetics, can put consumers at risk due to poor quality or misleading claims.

We also recognize FDA’s concerns regarding issuance of a regulation that would make an exception to
Section 201(ff)(3)(B) of the FD&C Act and allow the use of hemp-derived CBD as a food and dietary
supplement. As explained in our comments, many of the answers to FDA’s questions regarding the safety and
potential risk to consumers will depend on the specific composition of the hemp-derived ingredient, product
formulation, and intended use of the product at issue. For foods and dietary supplements, the Generally
Recognized as Safe (“GRAS”) and the new dietary ingredient (“NDI”) notification process provide the
mechanisms to establish the safe use of these products. Based on the safety information in the published
scientific literature and the data compiled by Roundtable members and the HIA, hemp-derived ingredients at the
dosages commonly used in food, dietary supplements, and cosmetics do not appear to pose safety risks to
consumers and therefore can be regulated by FDA like any other botanical ingredient used in these products. In
addition, we firmly believe that action by FDA to expressly permit the use of CBD-containing hemp ingredients
in food and dietary supplements will not serve as a disincentive to drug development, as there are several
examples of ingredients that have successfully co-existed as drugs and dietary supplements/food, such as fish
oil and niacin.

While we believe FDA’s existing regulatory framework for these product categories provides the
necessary guardrails for the safe production and marketing of products, we recognize that hemp-derived
ingredients such as CBD have unique considerations. Therefore in our comments we also offer additional
industry resources the agency can utilize to help assure quality and safety of hemp and CBD products. Together
with FDA’s existing rules and regulations, we believe the agency has sufficient means to address the safety,
quality, and appropriate labeling of food, dietary supplements, and cosmetics that contain hemp-derived
ingredients.

A. Health and Safety Risks

1
Press Release from Senator Mitch McConnell, Leader McConnell Discusses Hemp, CBD with Acting FDA Commissioner, June 27,
2019, available at https://www.mcconnell.senate.gov/public/index.cfm/pressreleases?ID=0B71B14E-5F77-4283-9084-
561F67EFBC70.

Paid for by U.S. Hemp Roundtable, Inc., an independent, nonprofit organization exempt from federal taxation under section 501(c)(4) of the
Internal Revenue Code. Contributions to U.S. Hemp Roundtable, Inc. are not deductible as charitable donations for federal income tax
purposes. 250 West Main Street, Suite 2800, Lexington, KY 40507.
FDA Docket No. 2019-N-1482
July 16, 2019
Page 3

1. Safety of CBD and Hemp-Derived Ingredients

The available scientific evidence demonstrates that CBD is generally well tolerated, even at high doses,
in healthy and non-healthy populations (Iffland, 2017). Last year, the World Health Organization (“WHO”)
concluded there are no public-health related concerns associated with the use of CBD nor is there any evidence
of CBD recreational use. As described in the report, WHO recognized that CBD does not produce the highs
that are seen with delta-9 tetrahydrocannabinol (“THC”), and in experimental models of abuse liability, CBD
exhibited no effects indicative of any abuse or dependence potential (WHO Report, 2018).

Furthermore, FDA’s own scheduling recommendation on CBD concludes that based on clinical and
available epidemiological data, “there is little indication that CBD has abuse potential or presents a significant
risk to the public health.” 2 In 2016, Food Standards Australia New Zealand also evaluated the safety of CBD
and determined that CBD is well tolerated at doses greater than 1000 mg per day and that there were no reports
of adverse effects of oral CBD in the literature (Cannabidiol Hazard Assessment, 2016).

CBD has been evaluated in healthy adults using a variety of tests for abuse potential as well as
physiological effects. In general, clinical studies have reported that even high doses of oral CBD does not
produce the same effects that are characteristic of THC (Grotenherman, 2016 and Consoroe, 1979). For
example, a single dose administration of CBD at 600 mg did not differ from the placebo on scales of the
Addiction Research Centre Inventory (“ARCI”), a 16 item Visual Analog Mood Scale, and subjective
measurements of intoxication or psychotic symptoms (Martin-Santos, 2012). In contrast, 10 mg of oral THC
administration was associated with subjective intoxication and euphoria as well as increased psychotic
symptoms and changes in ARCI scales reflecting sedation and hallucinogenic activity. In another recent study
of CBD in healthy adults, consisting of three arms, CBD was administered in single ascending dose (1500,
3000, 4500, or 6000 mg CBD), multiple dose (750 or 1500 mg twice daily) and food effect (1500 mg CBD
single dose) (Taylor, 2018). The results indicate that CBD was well tolerated with most adverse events being of
mild severity with no severe or serious events. The most common adverse events were diarrhea, nausea,
headache, and somnolence across all trial arms.
Even in highly sensitive populations of recreational polydrug users, CBD is associated with minimal
abuse potential. In one study, highly purified CBD was administered in single dose (750 mg, 1500 mg, and
4500 mg) and compared to that of single oral doses of alprazolam (2 mg), dronabinol (10 mg and 30 mg), and
placebo in healthy recreational polydrug users (Schoedel, 2018). The primary endpoint was the maximum
effect (E max ) on Drug-Liking visual analog scale (VAS). Compared with placebo, Drug-Liking was not
significantly different for subjects taking 750 mg CBD. Drug-liking E max values for 1500 mg and 4500 mg
CBD were significantly different from the placebo, but the mean differences were less than 10 points on the

2
Letter from Brett P. Giroir, Assistant Secretary of Health to The Honorable Robert W. Patterson, Acting Administrator, Drug
Enforcement Administration (My 16, 2018), available at https://hempindustrydaily.com/wp-content/uploads/2018/10/DHS-DEA-
letter-2018-0014-0002.pdf.

VAS scale compared to greater than 18 point differences between positive controls and the placebo.
Furthermore, in contrast to alprazolam, CBD administration had no observable effect on cognitive/psychomotor
tests and the majority of adverse events were of mild to moderate severity with no serious adverse events
reported. The most common adverse events included somnolence, diarrhea, headache, and abdominal pain.
Most CBD studies in humans involve acute CBD dosing in healthy and non-healthy subjects, in part
because the research has been limited due to CBD and hemp being misclassified as Scheduled I controlled
substances. However, studies in chronic dosing of CBD also demonstrate that CBD is well tolerated when
taken for an extended period of time. In the largest study thus far, 261 patients with epilepsy received CBD
together with their regular medication. Ten percent of the patients reported side effects of tiredness, diarrhea,
and exhaustion (Iffland, 2017). In another review article on the administration of CBD in epileptic patients, the
journal evaluated 35 papers that all studied CBD with a placebo comparator. The dosing ranged from 2.5-20
mg/kg/day across a mean treatment length of 14 weeks. Furthermore, earlier studies reviewed also reported
using a dosage of 100 mg of CBD administered 2-3 times per day for a treatment period between 8 and 26
weeks. The review concluded that administration of CBD reduced seizure frequency, improved aspects of
quality of life, and was generally well tolerated with mild-to-moderate adverse events. Notably, most of the
larger randomized controlled trials that were reviewed were in children and adolescents (Stockings, 2018).

In June 2018, FDA determined that CBD was safe and effective for the treatment of specific forms of
epilepsy at doses of 5 mg/kg twice daily (CDER, 2018). In its review, the Agency noted the most commonly
observed adverse events included somnolence and sedation, gastrointestinal, hepatic, and infection, which were
generally mild to moderate in severity. Serious adverse events were related to transaminase elevations,
somnolence and lethargy, and infections. Although FDA noted the potential for serious liver injury, the Agency
also concluded that such risk “can be appropriately managed with inclusion of relevant language in labeling.”
Based on the available data, we believe that there are no unique safety concerns associated with the
consumption of CBD that would preclude the use of FDA’s current regulatory framework in establishing
product-specific acceptable levels of use. We expect there to be more and continued research of various uses of
CBD following the creation of a clear legal pathway for these products. As discussed in our summary, we
believe the pathway for these products should take into account the intended use of the product, which will
dictate the acceptable safety levels permissible for hemp-derived CBD and other hemp extracts in food, dietary
supplements, and cosmetics.
While pure CBD studies have demonstrated that CBD is well tolerated even at doses as high as 6000
mg, hemp extracts with other cannabinoids may act differently based on the formulations. Therefore, each
formulation should undergo its own safety review under the current regulatory framework that FDA uses to
assess the safety of food and dietary ingredients. We anticipate the levels of use in food and dietary
supplements will be distinguishable from those approved for use in diseased populations such as patients with
severe epilepsy. However, we do not recommend setting a strict limiting standard on the amount of hemp
extract or CBD as the effects of these ingredients will likely be impacted by the specific product formulation.

a. Additional Product Safety Data for Humans and Animals

Both the Roundtable and HIA surveyed members for additional product safety data that may be useful to
FDA in its assessment of CBD. Three of our member companies have provided detailed reports of adverse
events received over one- to two-year periods. (Attachment 1 – Adverse Event Report Data). Not only does this
data show that adverse events overall (both serious and non-serious) are very low for hemp extracts and CBD
products, it also demonstrates that companies are complying with the post-market surveillance requirements
mandated by the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.
As shown in the attached materials, one of our member companies sold approximately 580,000 products
with zero serious adverse events reported to the company, and about 300 non-serious adverse reported for
humans and animals. Another member company has sold over 1.4 million products, with zero serious adverse
events and 623 non-serious adverse events. This company has also provided a thorough breakdown of its
reported adverse events in the attached materials. A third member company provided a summary of adverse
events/complaints related to human ingestion or topical application of their products along with the percentage
of adverse events/complaints per units sold. A fourth company provided adverse events related to human
ingestion and topical products reporting approximately 200 adverse events and zero serious adverse events, with
over 2 million products sold. Notably, the percentage of AERs for these companies (serious and non-serious) is
0.01-0.1 percent.
There are also various institutions that are developing systems to collect safety information about
products containing cannabis and cannabis-derived compounds. For example, as mentioned at FDA’s May 31st
hearing, ValidCare, LLC, a Colorado company, is developing a self-reporting, self-monitoring system that seeks
to gather data from CBD and hemp product users, including the side effects of the products they are consuming.
The system specifically includes the reporting of adverse events and will be marketed directly to the general
public. ValidCare has also submitted comments to FDA regarding this system.
With regard to data in animals, the National Animal Supplement Council has submitted comments to
FDA that included the following information from the NASC database regarding hemp and hemp-derived
compounds:

• “There are 149 products currently on the market

• Some have been on the market for 10 years
• We have statistical analysis in mg. per kg. Body Weight for Dogs, Cats and Horses
• There have been 9 adverse events reported, none serious, in over 18 million administrations in the 3
species mentioned above”
NASC notes that while it agrees additional research is needed, “the data at this time suggests these compounds,
provided by responsible companies, does not pose risk to dogs, cats and horses.” (Attachment 2 – NASC
Comments to FDA.)

2. Mode of Delivery

The Roundtable is primarily interested in promoting the marketing of CBD and hemp-derived
ingredients in dietary supplements, food, and cosmetics via oral and topical routes of administration. Cannabis
is widely consumed in human populations by different modes of delivery, and each mode produces unique and
different effects on human physiology, in large part because the pharmacology of cannabis-derived compounds
varies depending on the route of consumption. Historically, patients and recreational drug users have inhaled or
vaporized cannabis compounds for quick onset and higher peak concentrations (Campbell, 2017). However, as
discussed above, CBD does not produce the same highs as other cannabis compounds like THC, nor does it
have the same abuse potential. Therefore, we do not expect vaporization to be a common route of
administration for CBD and other hemp-derived ingredients.

Clinical investigations indicate that the oral bioavailability of CBD is low (13-19%) because it
undergoes extensive first pass metabolism and its metabolites are mostly excreted via the kidneys (Millar,
2018). In a review of pharmacokinetic studies in humans, the reported half-life of CBD was between 2-5 days
after chronic oral administration, 1.09-1.97 hours following single oral administration (10 and 20 mg), and 2.95-
3.21 hours following administration of 10 mg oral lipid capsules (Millar, 2018). Therefore, even amongst the
same mode of delivery, the effects and half-life of CBD is very different depending on the dosing and
formulation. Amongst other routes of administration the half-life of CBD also varied between 1.1 and 2.4 hours
following nebulizer and aerosol administration (20 mg), 1.44-10.86 hours after oromucosal spray administration
(5-20 mg), 24 hours after intravenous infusion, and 31 hours after smoking. Only one study reported the
bioavailability of CBD in humans, which was 31% following smoking. Furthermore, in comparison to
oral/oromucosal routes, the area under the curve and C max increase in dose-dependent manners are reached
quicker following smoking/inhalation. C max is also increased during fed states and in lipid formulations.

Another study evaluating the bioavailability of CBD following nasal and transdermal applications
suggests that oral administration of CBD is not ideal for therapeutic delivery because the oral bioavailability is
so low (between 6% to 33%) (Paudel, 2010). Therefore the study examined the intranasal and transdermal
delivery potential of CBD. Intranasal applications of CBD resulted in relatively rapid and significant absorption
of CBD from the nasal cavity (10 minutes) with a bioavailability of 34-46%. The bioavailability did not
improve with permeation enhancers. Through transdermal administration CBD provided significant plasma
drug levels (6.3 ± 2.1 ng/mL, which was attained at 15.5 ± 11.7 hours) after topical gel application in vivo.
Transcutol HP enhanced the CBD steady-state plasma concentration by 3.7-fold.

3. Drug Interactions

As discussed, CBD is generally well tolerated in healthy adults where even at high doses only mild
adverse events have been reported in several scientific studies. However, because CBD is extensively
metabolized in the liver, and in vitro data suggests that it may inhibit the CYP2C family of isozyme and
CYP3A4, as well as UBT1A9 and UGT2B7, it is important to understand if any of these signals translate to
impacts on drug-drug interactions in vivo (Taylor, 2018). For example, CBD is metabolized mainly by the

cytochrome P450 (CYP) 2C19 and CYP3A4 isoenzymes, which are induced by some antiepileptic drugs
(“AEDs”) and inhibited by others.

There have been reports of potential in vivo drug-drug interactions with some commonly prescribed
epilepsy drugs. For example, one study in children diagnosed with Dravet syndrome found that multiple dosing
of CBD in patients on regimens containing clobazam resulted in an increase in its major active metabolite N-
desmethylclobazam (Devinsky, 2018). However, there were no other interactions with several AEDs, and all 3
doses of CBD (5, 10, and 20 mg/kg/day) were generally well tolerated. However, the CBD group did result in
more adverse events than the placebo. Other studies have found similar results in both children and adults
taking AEDs along with CBD, which resulted in elevated liver function with sedation being the most common
side effect (Gaston, 2017 and Geffrey, 2015).
More research on drug-drug interactions should be conducted to understand the extent of CBD
administration with other forms of medication. However, even in the above referenced studies, CBD was well
tolerated in individuals that were ill and taking other medications to treat epilepsy. Thus, we believe concerns
regarding potential drug-interactions can be mitigated through consumer communication and education.

4. Vulnerable Populations

As with any other ingredient intended for use in foods, dietary supplements, or cosmetics, vulnerable
human populations must be considered when assessing the safety of the products. While CBD has been well
tolerated, even in studies with children with Dravet syndrome and refractory epilepsy, the research on CBD in
vulnerable populations is still emerging (Devinsky, 2018 and Geffrey, 2015). Similar to any other dietary
supplement or food ingredient, there are ethical considerations to conducting studies in healthy vulnerable
populations such as children and pregnant and lactating women. However, as discussed above, there are no
unique safety concerns associated with CBD compared to other dietary or food ingredients.
In a recent observational label study of 188 children and adolescents with autism spectrum disorder
(mean age 12.9 ± 7 years), patients were treated with an oil containing 30% CBD and 1.5% THC, on average
79.5 ± 61.5 mg CBD and 4.0 ± 3.0 mg THC, three times a day. The most common side effects, reported at six
months by 23 patients (25.2%, with at least one side effect) were: restlessness (6 patients, 6.6%), sleepiness (3,
3.2%), psychoactive effect (3, 3.2%), increased appetite (3, 3.2%), digestion problems (3, 3.2%), dry mouth (2,
2.2%) and lack of appetite (2, 2.2%). The study concluded that the “treatment appears to be safe and side
effects reported by the patients and parents were moderate and relatively easy to cope with.” (Bar-Lev
Schleider, 2019).

In a small observational study of 12 females (mean age 16.7 years) investigating the use of CBD-
enriched hemp oil to relieve symptoms and improve the quality of life in young with adverse drug effects
following human papillomavirus vaccine, patients were treated with 25 mg/ml per day divided into twice-daily
dosages, then supplemented by 2–5 mg/ml CBD once a week until intolerance or a maximum dose of 150
mg/ml CBD per day was reached over a three-month period. Only two of 12 patients (16%) withdrew from the

study due to an adverse event (hyperglycemia in one patient with diabetes mellitus, moderate sleepiness and
confusion in the second patient) and no significant adverse effects were observed in the patients throughout the
trial (Palmieri, 2017).
In general, there has been limited research on the effects of chronic exposure to low doses of hemp
extracts or CBD. Therefore, as with any other supplement, caution should be taken before allowing vulnerable
populations to consume supplements containing hemp-derived ingredients. We believe concerns regarding
vulnerable populations can be addressed by labeling and post-market adverse event monitoring. Many dietary
supplements on the market include advisories or special labeling instructions for specific populations such as
children or pregnant women. Similarly, any potential safety concerns with CBD in vulnerable populations
could be addressed by labeling.

5. Safety Monitoring for Adverse Events

We recognize that continued safety monitoring is necessary to ensure long-term use and exposure to
these products continues to present no safety concerns. We recognize that innovative research on the various
forms of CBD and hemp-extracts has been stalled in part due to the Scheduled I Controlled Substance status of
these products until recently, which has prevented innovations in research especially in healthy populations at
levels below those typically used in drug clinical trials. However, as discussed above, in the research that has
been conducted, there have been no signals of a clinically meaningful safety concern for these products.
We believe FDA’s mandatory adverse event reporting system for dietary supplements and voluntary
reporting system for cosmetics and food will provide crucial post-market safety information once the Agency
establishes a clear regulatory pathway for hemp-derived ingredients. As there are no unique safety concerns for
CBD, we believe FDA’s current post market surveillance systems are sufficient.
As discussed above, there are some concerns related to drug-drug integrations with therapeutic doses of
CBD in patients taking other commonly prescribed epilepsy drugs. However, because the bioavailability of
CBD is low across various modes of delivery (i.e., oral consumption, nasal, and transdermal), and CBD is well
tolerated even at high doses, we do not believe there are specific safety concerns that would result from the
overlap of low chronic exposure to CBD in the form of dietary supplements and therapeutic dose levels.
However, any potential concerns could be mitigated through appropriate labeling advisories for consumers that
are taking therapeutic forms of CBD, e.g., directing consumers to consult a physician before taking dietary
supplements of food containing CBD or other hemp-derived ingredients.

6. Margin of Exposure

As discussed above, it is difficult to set maximal acceptable daily intake levels of hemp-derived products
because the levels and modes of delivery in the general population vary greatly. Therefore, the margin of
exposure of any product will be based on its intended use and formulation. For example, the exposure for pure
CBD will likely be different from hemp extracts.

As with any dietary supplement, food, or cosmetic ingredient, FDA’s current regulatory framework is
sufficient to evaluate safety concerns of hemp-derived ingredients, including CBD. For example, FDA’s GRAS
procedures provide that firms must evaluate the substances dietary exposure. This includes an evaluation of any
self-limiting levels of use and the history of consumption of the substance by a significant number of
consumers. Similarly, NDI notifications often provide evidence that the substance was safely consumed as a
food or dietary supplement. This may include information about the mean and high (e.g., 90th percentile)
exposure levels and intake level of the dietary ingredient based on the intended conditions of use, or related
scientific evidence on the ingredient. Furthermore, the safety assessment should describe and discuss situations
in which conditions of use and composition of the new dietary ingredient differ from the documented conditions
of use. Therefore, the burden of establishing margins of exposure for hemp-derived ingredients will be on the
manufacturers completing the self-GRAS process, or submitting GRAS and NDI notifications to FDA.

7. General Use in Food

In December 2018, the FDA issued three “no questions letters” in response to GRAS notifications for
hemp seed-derived food ingredients. Therefore, companies have already used FDA’s regulatory framework to
establish the safety of cannabis-derived products for use in food. In addition, cannabis has been grown in
various locations around the world and has commonly been used in cooking as an herb, an additive, and also
consumed as tea (Booth, 2004). In recipes, cannabis has been used in beverages and added to home-made
sweets, biscuits, and cakes.
In 2018, Roundtable member CV Sciences published a study examining the genotoxicity and subchronic
toxicity of hemp extract to understand its toxicological profile as part of its self-affirmed GRAS assessment. A
battery of toxicological studies were conducted on the hemp extract containing about 25% cannabinoids. No
evidence of genotoxicity was found and a 14-day repeated oral dose-range finding rat study at 1000, 2000, and
4000 mg/kg bw/day resulted in effects where a NOEL could not be concluded (Marx, 2018). Based on those
results, a 90-day repeated dose oral toxicity study was performed in rats using doses of 100, 360, and 720 mg/kg
bw/day, followed by a 28-day recovery period for two satellite groups. Significant decreases in body weight,
body weight gain, and differences in various organ weights compared to controls were observed. At the end of
the recovery period, many of the findings were trending toward normal; thus, the changes appeared to be
reversible. The NOAEL for the hemp extract was determined to be 100 mg/kg bw/day for males and 360 mg/kg
bw/day for females. The study concluded that the hemp-extract was nonmutagenic, nonclastogenic, and
nongenotoxic in the current bacterial reverse mutation, in vitro mammalian chromosomal aberration, and in vivo
mouse micronucleus tests, respectively.
Recently, Manitoba Harvest also announced that it completed a safety assessment and self-affirmed its
Broad Spectrum Hemp Extract as GRAS. The GRAS applies to the intended use in products for the general
population age 2 years and older excluding pregnant and lactating women. Its hemp extract products include 15
mg CBD plant protein powder, 10 mg CBD oil drops, 5 mg CBD oil spray, and 15 mg CBD oil soft gel formats
(Manitoba, 2019).

8. Impact of Commercial Availability of Non-Drug CBD Products on Incentives for Drug

Development

We believe the widespread commercial availability of CBD-containing food and dietary supplements
will not have a significant effect on the incentives for drug development. The fact that an ingredient can be
studied or used as a drug is not a fundamental consideration when determining how a product should be
regulated by FDA. Rather, the intended use of a product – typically based on labeling claims – will determine
how FDA will regulate the product under the FD&C Act. The law also sets clear boundaries that prohibit the
promotion of a product to diagnose, cure, mitigate, treat, or prevent disease without approval from FDA,
thereby preserving the ability of drug companies to research and market products for these uses. This system
has allowed products such as fish oil and pre-natal vitamins to co-exist as both as drugs and dietary supplements
for many years without negatively impacting drug development.

Like other ingredients used in FDA-regulated products, CBD and other hemp-derived ingredients
continue to be studied for both serious medical conditions as well as mild conditions amenable to self-treatment.
The FD&C Act provides the means to promote products for these uses in a manner that clearly distinguishes
drugs from food, dietary supplements, and cosmetics – even in cases where there is overlap among ingredients
used in these products. FDA has sent numerous Warning Letters to companies marketing products, including
CBD products, for conditions that caused these products to be unapproved drugs. We encourage FDA to
continue these efforts and to take further enforcement action, such as seizures or injunctions, in cases where
companies willfully ignore the law.
Further, under these same laws, manufacturers are already required to determine what levels of CBD
and hemp ingredients are acceptable for non-drug products based on the adulteration provisions specific to these
products. Additional mechanisms such as the NDI provisions of the FD&C Act and GRAS procedures provide
further means for establishing safe levels of these ingredients. Therefore, we do not believe that it is necessary
for FDA to establish threshold levels for hemp-derived CBD as these levels will vary based on the composition
and intended use of the product.
Summary of Recommendations:

• CBD does not appear to pose unreasonable safety risks to consumers and therefore can be regulated by
FDA like any other botanical ingredient used in these products. This position is supported by clinical
studies conducted at dosages at or above what is commonly used in dietary supplements, food, and
cosmetics. Several of these studies are in sensitive populations.
• Appropriate levels of CBD will be much lower in food and dietary ingredients than those used in
pharmaceutical products. However, we advise against establishing arbitrary dose limits for these
products as the effects of the CBD will vary greatly based on the intended use, formulation, and mode of
delivery. Each manufacturer has the burden to establish its specific product formulation is safe for the
intended population through FDA’s current regulatory framework.

• Safety concerns that may arise from the lack of data in vulnerable populations such as children, pregnant
or lactating women, and patients taking therapeutic levels of CBD can be addressed in the labeling of the
product with adequate advisory language and directions for use.
• FDA’s current regulatory system supports incentives for drug development, and clearly and sufficiently
distinguishes these products from food and dietary ingredients based on their intended use and labeling.

B. Manufacturing and Product Quality

1. Safety Standards Related to Manufacturing, Processing, and Holding Hemp-Derived

Products

The FDA’s existing current Good Manufacturing Practices (“cGMPs”) for food and dietary supplements
establish mandatory standards for sanitary operations, training, processes and controls to ensure that products
and their ingredients are not contaminated with harmful or undesirable substances such as pesticides, biological
hazards, heavy metals, or other impurities. Additional safety measures put in place by the Food Safety
Modernization Act (“FSMA”) requires a hazard analysis and risk-based preventive controls for all foods and
dietary ingredients. Further, FDA’s implementing rules related to FSMA impose food safety-related
requirements for both food and dietary supplements. Thus, like any other botanical product, CBD and other
hemp-derived products labeled as dietary supplements or food are subject to comprehensive and robust
standards to ensure products are manufactured and held in a safe manner. In fact, it is imperative that the hemp
food and supplement industries have FDA oversight to protect the public from products made without cGMP
manufacturing standards. We encourage FDA to continue to use its authority under the FD&C Act to enforce
against companies that fail to meet these standards as the products would be considered adulterated or
misbranded under the law.
Although cosmetics are not subject to mandatory cGMPs, these products are also subject to adulterations
provisions under the FD&C Act. Therefore cosmetics that contain hemp-derived CBD must be manufactured
and processed in a manner that ensures the safety of the final product.

For hemp and CBD dietary supplements, we note that 21 CFR Part 111 requires dietary supplement
firms to take a number of actions prior to using hemp-derived ingredients. We believe these requirements
thoroughly address important sourcing, supply chain, and safety issues, such as:

• Establishing the identity of the ingredient using appropriate methods and testing that is specific to
the ingredients, and maintaining documentation demonstrating that such testing is fit for purpose
• Using appropriate methods for extraction, concentration, and purification processes, which
demonstrates knowledge of the ingredient manufacturing process
• Characterization of all components of the ingredient, including all cannabinoids and other plant
compounds, as well as setting and meeting specifications for these components
• Use of scientifically valid test methods and acceptance criteria that are specific, accurate, and precise
• Use of stability studies and data to substantiate expiration dating

The Roundtable requires its members to follow all applicable federal requirements including those
provided in the FD&C Act and encourages its members to adopt voluntary best practices where available, such
as FDA’s Draft Guidance for Industry on Cosmetic Good Manufacturing Practices 3 and AHPA’s Guidance on
Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials. 4
In addition, the U.S. Hemp Authority Certification Program Guidance (hereinafter “the Guidance”)
provides high standards, best practices and self-regulation throughout the supply chain to give consumers
confidence that hemp products are both safe and legal. 5 This effort is funded by the Roundtable and joined by
organizations such as HIA, and provides comprehensive guidance for growers and processors of hemp and was
developed by the industry’s leading firms, top-tier testing laboratories, and quality assessors. Hemp product
producers that meet the stringent self-regulatory standards of the U.S. Hemp Authority and pass a third-party
audit are eligible to use the Certified Seal of the U.S. Hemp Authority.
The Guidance includes standards for growers, processors/manufacturers, and brand owners that address
the following key components of safety:

• Personnel guidance, including safety measures, sanitation procedures, and employee training
• Standards for physical plants and grounds
• Supplier qualification and specifications
• Contaminant Testing and Hemp Cannabinoid Quantification, which includes testing for and
acceptable levels of contaminants (e.g., heavy metals, microorganisms, pesticides and residual
solvents), based on guidance published in the American Herbal Pharmacopoiea (AHP) Cannabis
monograph and the American Herbal Products Association (AHPA) Guidance Policies
• Cannabinoid potency methods to determine the concentration of cannabinoids and effectively
distinguish cannabis as either legal hemp or marijuana
• Storage and distribution of hemp and hemp products
• Quality controls related to product complaints, adverse events, and recalls

2. Standards and Processes to Ensure Manufacturing Quality and Consistency of Products

In addition to meeting safety standards, hemp-derived products must be produced in a manner that
assures the quality and consistency of the final product. The federal cGMPs for dietary supplements and food
mandate that manufacturers have quality controls in place to ensure product integrity and that products have

3
U.S. Food and Drug Admin., Draft Guidance for Industry: Cosmetic Good Manufacturing Practices (June 2013), available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-
practices.
4
American Herbal Products Assoc., Guidance on Good Agricultural and Collection Practices and Good Manufacturing Practices for
Botanical Materials (March 2017), available at http://www.ahpa.org/Portals/0/PDFs/Policies/Guidance-
Documents/AHPA_Good_Agricultural_Collection_Practices_Good_Manufacturing_Practices_Botanical_Materials.pdf.
5
U.S. Hemp Authority™ Certification Program, Guidance Procedures Growers Processors / Manufacturers Brand Owners (May 27,
2019), available at https://www.ushempauthority.org/docs/US-Hemp-Authority_Certification-Program-Guidance_05-28-19.pdf.

been manufactured, packaged, labeled, and held under conditions to prevent adulteration. The cGMPs for
dietary supplements also require that products meet established specifications for identity, purity, strength, and
composition, and limits on contaminants.
Similar to other botanical substances, hemp ingredients have varying levels of constituents depending on
factors such as where the starting hemp material was grown and the specific strain of hemp. Robust quality
systems are essential for ensuring that hemp products that contain CBD and other active plant compounds are
accurately labeled and meet all label claims.

In addition to the components listed above that address safety, the U.S. Hemp Authority Guidance also
provides detailed standards for quality management systems (“QMS”) for hemp products. These standards
address, among other things, quality control procedures and guidance for packaging, labeling, and other related
operations to ensure that hemp products are packaged and labeled as specified in the manufacturing record.

3. Validated Analytical Testing to Support the Manufacturing of Safe and Consistent

Products

Validated analytical testing is necessary to help ensure that hemp-derived CBD food, supplements, and
cosmetics meet the standards for safety and quality discussed above. The Roundtable supports the efforts of
organizations such as the American Society for Testing and Materials (“ASTM”) International, American
National Standards Institute (“ANSI”), and the U.S. Pharmacopeial Convention (“USP”) to develop reference
test methods and consensus standards for the manufacturing and testing of cannabis-derived ingredients such as
CBD to ensure the quality and safety of these products.

The U.S. Hemp Authority Guidance also advises that laboratories adopt methods developed by the
Association of Analytical Communities (“AOAC”) to help ensure that methods for measuring cannabinoids are
fit for purpose, accurate, and provide precision especially with regard to quantifying THC concentrations in
products.

In rulemaking and/or guidance, FDA should mandate the use of validated analytical test methods to
support the manufacturing of safe and consistent products that meet labeling claims. Such testing methods
would help ensure that the amount of cannabinoids, terpenes, and other compounds, depending on the specific
product, are accurately labeled and that contaminants are detected.

4. Standardized Definitions for Ingredients

Currently there are no standardized definitions for the various types of hemp-derived ingredients used in
dietary supplements, food, and cosmetics. We are aware that companies use terms such “full spectrum hemp
extract” and “broad spectrum hemp extract” to describe the composition of certain hemp-derived ingredients,
primarily for marketing purposes. For example, “full spectrum hemp extract” often refers to hemp extract that
contain all constituents found in hemp (including trace amounts of THC). Broad spectrum hemp extract

typically refers to extracts that contain no detectable level of THC and an array of cannabinoids, terpenes and
other constituents found in hemp, with the exception of THC.

Regardless of the specific terms used, we believe products should be accurately labeled and any terms
used to describe a product or its ingredients should reflect the actual contents. Should FDA determine that
standardized definitions are necessary, the Roundtable encourages the agency to work with industry
stakeholders to develop appropriate definitions for CBD and other hemp-derived products.

5. Functional Purposes of Hemp-Derived CBD in Food

Manufacturers add hemp-derived ingredients such as CBD to foods, including dietary supplements, for
the purpose of enhancing the food’s nutritive value and providing health and wellness benefits. We believe
consumer perceptions and expectations regarding foods that contain hemp-derived CBD are generally consistent
with manufacturers’ intent. Probiotics in yogurt and omega-3 fatty acids found in fish are consumed for similar
reasons.

Summary of Recommendations:

• The Roundtable urges FDA to use its existing authority under the FD&C Act to enforce the mandatory
cGMPs to protect consumers from unsafe products and ensure that all hemp-derived products are
produced in a quality, consistent manner and accurately labeled.
• We also encourage FDA to consider adopting the standards provided in the U.S. Hemp Authority
Guidance and work with standard-setting organizations such as ASTM, ANSI, AOAC, and USP to
develop validated analytical testing and consensus-based standards for quality and safety. In future
guidance or rulemaking, we also recommend that FDA to include consensus-based, validated standards
and methods for cannabinoid content, specifically CBD and THC.
• If FDA determines that standardized definitions are necessary, we encourage FDA to work with industry
stakeholders to develop these definitions.

C. Marketing, Labeling, and Sales of Hemp and CBD Products

1. Informing Consumers About Potential Risks Associated with Hemp and CBD Products
The adulteration and misbranding provisions of the FD&C Act apply to all products labeled as for
dietary supplements, foods, and cosmetics; thus, products must be safe when used under the conditions
prescribed in labeling, or under ordinary conditions of use. Further, under the misbranding provisions of the
Act, product labeling cannot include false or misleading information. Depending on the specific composition,
dosage, and intended use of the product, the directions for use and potential advisories will vary from product to
product. Although the safety of CBD is well established, as discussed in Section A., minor side effects and
drug interactions have been associated with CBD. Like other ingredients on the market, there is currently a lack
of data on the effects of CBD and other hemp-derived ingredients on vulnerable populations such as children
and pregnant women. Therefore certain consumers and subpopulations may benefit from label advisories on
products that contain CBD or other hemp-derived ingredients.
Paid for by U.S. Hemp Roundtable, Inc., an independent, nonprofit organization exempt from federal taxation under section 501(c)(4) of the
Internal Revenue Code. Contributions to U.S. Hemp Roundtable, Inc. are not deductible as charitable donations for federal income tax
purposes. 250 West Main Street, Suite 2800, Lexington, KY 40507.
FDA Docket No. 2019-N-1482
July 16, 2019
Page 15

In addition to mandating that all dietary supplements and food be labeled in accordance with FDA
regulations, the U.S. Hemp Authority Guidance provides that all products containing measurable amounts of
cannabinoids should include proper advisories and cautions, such as the following:
o This product should be used with caution when driving motor vehicles or operating heavy
machinery.
o Use this product under the guidance of a physician if you have a medical condition, are pregnant
or lactating.
o Keep out of the reach of children.
o This product meets federal requirements for hemp products, however consumption may be
flagged by some drug tests.

2. State Approaches to Regulating CBD-Containing Food Products

States currently take a wide variety of approaches to regulating hemp-derived products including CBD.
Several states have enacted legislation that permits the addition of hemp and hemp-derived CBD products in
food, dietary supplements, and cosmetics, provided the THC concentration is no more than 0.3%. Other states
have announced policies that restrict the sale of CBD and/or hemp; in some cases these policies are specific to
the addition of hemp or CBD to food and dietary supplements.

Increasingly, however, states are moving to ease restrictions or expressly allow the use and/or sale of
hemp and CBD in a broad range of products. A growing number of states are also imposing specific testing and
labeling of hemp and CBD products in the absence of clear guidance from FDA on the regulation of these
products. While the Roundtable has been actively engaged at the state level to educate state regulators and
supports access to safe, regulated hemp and CBD products, the lack of consistent regulation among the states
combined with uncertainty at the federal level continue to cause consumer and industry confusion, in particular
due to varying labeling requirements.

We believe that a federal regulatory framework, rather than a patchwork of state and local laws,
provides the best means for ensuring consumers receive accurate, consistent information about hemp-derived
products. Food, dietary supplements, and cosmetics are already subject to a robust legal requirements that
prohibit adulterated and misbranded products. Given the well-established safety profile of CBD, additional
statutory or regulatory restrictions – whether federal, state or local – are unnecessary. However, FDA has the
relevant public health expertise to determine what conditions or limitations, if any, should be in place for foods,
dietary supplements, and cosmetics that contain hemp-derived ingredients, rather than having individual states
determine what restrictions should be in place for these products.
As indicated above, the labeling of dietary supplements and food could include language that advises
consumers to consult with their healthcare professional before using a product that contains hemp-derived CBD,
or that recommends against the use of the product by certain populations, e.g., children or pregnant/lactating
women, if deemed necessary by the manufacturer/distributor of the products. While many dietary supplement

companies already include such advisories on products labels, in guidance and/or rulemaking FDA could
require uniform advisories on all hemp-derived CBD products (food, dietary supplements, and cosmetics).

Summary of Recommendations to FDA:

• FDA should continue to actively enforce the adulteration and misbranding provisions of the FD&C Act
to ensure consumers are informed of any risks associated with the use of hemp products.
• Existing federal laws and regulations provide the most appropriate mechanism to inform consumers in a
uniform, consistent manner of the potential risks of products that contain hemp-derived ingredients,
thereby obviating the need for state restrictions.
• FDA, rather than states, is best suited to determine whether the current labeling of dietary supplements
and food containing hemp-derived ingredients should include additional language to inform consumers,
in particular vulnerable sub-populations.
• Should FDA determine that advisory language is necessary for products containing CBD or other hemp-
derived ingredients, we recommend that FDA consider utilizing the advisory language provided in the
U.S. Hemp Authority Guidance.

* * *

Again, we thank FDA for the opportunity to submit these comments. The Roundtable looks forward to
working with FDA as it develops its pathway forward for hemp and CBD products.

Respectfully Submitted,

Jonathan Miller
General Counsel, U.S. Hemp Roundtable

Rend Al-Mondhiry
Suzanne Bassett
Ashish Talati
Amin Talati Wasserman, LLP

References
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Safety and Efficacy, Scientific Reports (2019), Jan 17;9(1):200.
Booth, M., Cannabis A History, (2004), Picador, U.S.A.

Cannabidiol hazard profile – Proposal P1042. Low THC Hemp Seeds as Food. Food Standards Australia New
Zealand, (2016), available
at http://www.foodstandards.gov.au/code/proposals/Documents/P1042%20Low%20THC%20hemp%20
CFS%20SD2%20Cannabidiol%20hazard.pdf.

Cambell, T. et al., Cannabinoids in Pediatrics, J. Pediatr. Pharmacol. Ther., (2017), 22(3).

Center for Drug Evaluation and Research. Application Number 210365Orig1s000. Summary Review, (June 22,
2018), Food and Drug Administration available at
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000SumR.pdf.
Devinsky, et al., Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome, Neurology, (Apr. 3,
2018), 90(14): e1204–e1211.
Gaston et al., Interactions between cannabidiol and commonly used antiepileptic drugs, Epilepsia, (Sep. 2017),
58(9):1586-1592.

Geffrey et al., Drug-drug interaction between clobazam and cannabidiol in children with refractory epilepsy,
Epilepsia (2015), 56(8):1246–1251.
Iffland, K. and F. Grotenhermen, An Update on Safety and Side Effects of Cannabidiol A Review of Clinical
Data and Relevant Animal Studies. Cannabis Cannabinoid Res., (2017), 2(1).
Manitoba Harvest, Manitoba Harvest Announces Broad Spectrum Hemp Extract Self-Affirmed GRAS Status,
Press Release, (May 31, 2019) available at https://www.prnewswire.com/news-releases/manitoba-
harvest-announces-broad-spectrum-hemp-extract-self-affirmed-gras-status-300858631.html.

Martin-Santos, R., et al., Acute effects of a single, oral dose of d9- tetrahydrocannabinol (THC) and cannabidiol
(CBD) administration in healthy volunteers. Curr Pharm Des, (2012), 18(32): p. 4966-79.
Marx, T. et al. An Assessment of the Genotoxicity and Subchronic Toxicity of a Supercritical Fluid Extract of
the Aerial Parts of Hemp, J. Toxicology, (Volume 2018), Article ID 8143582.

Miller, et al., A Systemic Review on the Pharmacokinetics of Cannabidiol in Humans, Frontiers in

Pharmacology, (2018), 9:1365.
Palmieri, et al., Cannabidiol bioavailability after nasal and transdermal application: effect of permeation
enhancers, Isr. Med. Assoc. J., (2017), 19 79–84.

Paudel, et al., Short-Term Efficacy of CBD-Enriched Hemp Oil in Girls with Dysautonomic Syndrome after
Human Papillomavirus Vaccination, Drug Devel. And Industrial Pharmacy, (2010); 36(9).

Schoedel et al., Abuse potential assessment of cannabidiol (CBD) in recreational polydrug users: A randomized,
double-blind, controlled trial, Epilepsy Behav., (Nov. 2018) 88:162-171.
Stockings E, et al. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and
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Taylor, et al. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple
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Company 1
Human THC Free*
June 7, 2017 - Human Product #1 Human Product #2 Human Product #3 Human Product #4 Human Product #5 Human Product #6 Human Product #7 Vape Product #1 Pet Product #1 Pet Product # 2 (Full Product #1 (CBD
June 21 2019 (Full Spectrum) (Full Spectrum) (Full Spectrum) (Full Spectrum) (Full Spectrum) (Full Spectrum) (Full Spectrum) (CBD Isolate) (Full Spectrum) Spectrum) Isolate) Grand Total

mg per serving 3-5 mg 20-25 mg 20-25 mg 3-5 mg 3-5 mg 20-25 mg 10-15 mg - 3-5 mg 10-15mg 20-25 mg
max daily mg 40-45 mg 40-50 mg 40-50 mg 40-45 mg 40-45 mg 40-50 mg 55-60 mg - 40-45 mg 55-60mg 90-100 mg
Total AR (Adverse
Reaction) 64 44 41 36 35 32 29 20 6 0 1 308
Total SAR (Serious
Adverse Reaction) 0 0 0 0 0 0 0 0 0 0 0 0.00%
Units Sold 180508 34739 70520 96716 60351 24197 57568 17243 28326 3511 7168 577336
AR per SKU 0.04% 0.13% 0.06% 0.04% 0.06% 0.13% 0.05% 0.12% 0.02% 0.00% 0.01% 0.05%
Stomach 23 14 7 6 11 5 7 2 4 79
Allergy 10 5 5 8 7 6 9 7 57

Headache 9 2 5 6 3 3 2 3 33
Nausea 6 6 5 1 7 1 2 2 30
Anxiety 7 4 4 5 1 2 2 1 26
Felt Strange 3 1 8 1 3 1 1 1 19

Burning 1 5 2 4 1 4 1 18
Respiratory 2 1 1 3 2 9
Acid Reflux 3 1 2 1 2 9

Dizzy 2 1 1 2 6
Sick 1 1 1 1 4
Heart Racing 1 1 2 4
Shaky 1 2 3
Tingling 1 1 2
Mouth Sore 1 1 2
Numbness 1 1 2
Fatigue 1 1
Bladder 1 1
Blood Pressure 1 1
Eye Twitch 1 1
Restless 0
Yeast Infection 1 1
Company 2 - AER Summary

Supplements 5-
Sprays 1-5mg Drops 1-7mg Gum 5-7mg
30mg
2018 - 2019 Grand Total

Total AR (Adverse Reaction)

144 226 1 252 623
Total SAR (Serious Adverse
Reaction) 0 0 0 0 zero
Units Sold 314,309 380,435 14,370 713,311 1,422,425
AR rate per category 0.05% 0.06% 0.01% 0.04% 0.04%
Company 2 - Raw Data

15-20 mg CBD Supplement; 4,638

15-20 mg CBD Supplement; 5,624

10-15 mg CBD Supplement; 2,724

15-20 mg CBD Supplement; 5,657

10-15 mg CBD Supplement; 3,285

10-15 mg CBD Capsules; 72,405

15-20mg CBD Capsules; 104,200

5-7mg CBD Supplement; 17,303

5-7mg CBD Supplement; 10,677

15-20mg CBD Softgels; 149,645

15-20mg CBD Softgels; 119,998

25-30mg CBD Capsules; 10,429

5-7mg CBD Supplement; 9,259
15-20mg CBD Softgel ; 72,405

5-7 mg CBD Softgels; 16,326

5-7 mg CBD Softgels; 20,019

1-3 mg CBD Spray; 128,479

10-15mg CBD Caps; 88,717

3-5 mg CBD Drops; 91,168

5-7 mg CBD Drops; 52,226

3-5 mg CBD Spray; 33,020
3-5 mg CBD Drops; 74,390

5-7 mg CBD Drops; 79,004

3-5 mg CBD Drops; 12,022

1-3 mg CBD Drops; 21,511

1-3 mg CBD Drops; 15,822

1-3 mg CBD Drops; 18,045

5-7 mg CBD Gums; 14,370
1-3 mg CBD Spray; 68,865

5-7 mg CBD Drops; 8,649

3-5 mg CBD Drops; 7,598

1-3 mg CBD Spray; 3,565

3-5mg CBD Spray; 5,990

3-5 mg Spray; 74,390
TOTAL
Product ID 102 95 104 103 94 96 107 105 97 187 106 137 189 22 140 188 184 151 327 334 25 326 333 311 148 141 310 335 309 336 183 312 163 154
abdominal discomfort 4 12 5 7 11 6 5 1 6 0 6 12 1 0 2 0 4 0 2 3 1 1 0 1 1 1 0 0 1 0 1 0 1 0 95
malaise 7 5 2 6 3 2 6 1 2 0 3 6 0 2 0 0 0 1 0 0 1 0 0 0 1 0 1 0 1 0 1 0 0 0 51
headache 6 3 4 2 4 4 4 2 6 0 3 2 0 0 2 0 1 0 0 0 1 2 1 0 0 2 0 0 0 0 0 0 0 0 49
hypersensitivity 3 8 2 2 5 1 6 1 2 0 3 2 1 0 0 0 0 0 1 1 0 0 0 1 0 1 2 0 0 0 0 0 0 0 42
dyspepsia 2 2 4 0 4 2 1 1 2 0 5 2 0 1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 30
adverse reaction 1 2 2 1 2 1 6 0 1 0 1 2 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 21
lack of effect 1 3 5 0 2 1 4 1 1 0 1 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 21
nausea 2 4 1 1 2 2 1 0 7 0 3 1 0 0 3 0 2 1 0 0 0 0 0 0 1 0 0 1 0 1 1 0 0 0 34
feeling abnormal 1 0 1 2 2 0 1 0 1 0 1 1 0 0 0 0 2 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 13
pruritus 0 1 1 0 1 1 0 1 3 0 1 1 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12
dermatitis 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
rash 1 2 1 0 1 0 1 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8
urticaria 1 1 0 1 1 0 0 0 1 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7
anxiety 1 1 2 2 2 0 4 1 2 1 3 1 1 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 23
gastrointestinal disorder 1 1 1 0 0 2 2 0 0 0 3 0 0 0 2 0 2 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 16
somnolence 1 0 0 0 1 0 2 0 0 0 0 2 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7
heart rate increased 0 0 0 1 1 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 6
feeling anxious 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
dizziness 1 1 1 0 0 0 1 0 0 0 1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 8
hypertension 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 4
flushing 0 1 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 4
canker sores 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 4
diarrhea 0 1 1 0 0 1 0 0 1 0 0 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7
gastroesophageal reflux 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
feeling jittery 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
anxeity 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
insomnia 2 0 0 0 1 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 6
Abdominal pain 0 1 0 0 0 2 1 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6
oropharyngeal pain 1 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
abnormal dreams 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
tinnitus 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
hyperactivity 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
paresthesia 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
blood pressure increased 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
depression 0 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
disorientation 2 0 0 0 0 0 1 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 6
drug-supplement interaction 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
euphoria 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
lethargy 1 1 0 0 0 1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5
gingivitis 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
decreased efficacy 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
asthma exacerbation 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
syncope 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
oral pain 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4
medication interaction 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
eructation 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
stomatitis 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
burning sensation 0 1 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
pharyngitis 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
vision blurred 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
lucid dreaming 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
dysgeusia 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
hyperalgesia 0 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 4
emesis 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Ocular pain 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Generalized Rash 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Constipation 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 3
Epistaxis 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
hypotension 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
oral canker 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
conjunctivitis 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
migraine 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 2
pharyngeal pain 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
restless legs 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
cystitis 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
xerosis 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
arthralgia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
suicidal ideation 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
gastritis 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
pre-syncope 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
nightmares 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
palpitations 0 1 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
lightheadedness 0 0 0 1 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3
arrhythmia 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
gum hemorrhage 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
discoloration mouth 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
liver function test abnormal 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
dyspnea 0 1 0 0 0 0 0 0 0 0 1 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4
agitation 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
influenza-like illness 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
swelling 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
tongue discoloration 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
paresthesia oral 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
dehydration 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
bullae 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
rash 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
throat swelling 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
hallucinations 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
fatigue 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
pain increased 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
felt abnormal 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
malaise 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
allergy 0 1 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 4
twitching 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
vomiting 0 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 5
peripheral swelling 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
visual disturbance 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
sleep disturbance 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
pharyngeal discomfort 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Mental Status change 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
paresthesis oral 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
abdominal distension 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
confusion 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
sneezing 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
edema 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
paranoid thoughts 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
discoloration teeth 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
skin discoloration 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
chest pain 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1
chest tightness 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
swelling mouth 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
contact dermatitis 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
excessive phlegm 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
erythema 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
abnormal thinking 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
borborygmi 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
enuresis 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
nasal congestion 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
interaction with medication 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
flatulence 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
pain 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
dysphagia 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
muscle spasms 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
TOTAL 49 72 41 32 56 29 72 12 44 2 49 51 6 6 22 3 16 4 4 4 4 3 1 9 7 5 4 1 4 2 5 1 1 2 623
Company 3

Summary of Data Provided

This data captures complaints / adverse events reported for products sold during the period of 1/1/18 through 6/29/19.
We are a large hemp extract company and sold several hundreds of thousands of units of our hemp extract products
during this period. Below is the percentage of complaints / adverse events reported during this period that were related
to human ingestion or topical application of our products (exclusive of complaints solely related to the customer not
liking the taste of ingestibles or texture of topicals). Complaints not related to actual ingestion or topical application (e.g.
shipping, order issues, etc.) are not included in this data.

Complaint/AE
Product Description Percentage Complaint / Adverse Event Descriptions
of Units Sold
These minimal complaints were primarily due to no
effect with nominal or isolated incidents of allergic
Hemp Extract MCT Tincture, 300mg CBD, C 0.014%
reaction, stomach pain, "feeling badly," and a side
effect
Hemp Extract MCT Tincture, 100mg CBD, C 0.000% None
These minimal complaints were primarily due to no
Hemp Extract MCT Tincture, 3600mg CBD, C 0.109% effect with nominal or isolated incidents of nausea,
feeling sick, and "feeling badly"
These minimal complaints were primarily due to no
effect with nominal or isolated incidents of
Hemp Extract MCT Tincture, 300mg CBD, N 0.027%
headaches, upset stomach, "feeling worse," "bad
effect," and dissatisfaction
Hemp Extract MCT Tincture, 100mg CBD, N 0.000% None
These minimal complaints were primarily due to no
Hemp Extract MCT Tincture, 3600mg CBD, N 0.060% effect with nominal or isolated incidents of feeling
sick, not feeling well, and a side effect
Hemp Extract VG Tincture, 300mg CBD, G 0.014% Isolated incident of indigestion
These minimal complaints were due to isolated
Hemp Extract VG Tincture, 600mg CBD, G 0.043%
incidents of stomach issues and hives
Hemp Extract VG Tincture, 300mg CBD, N 0.000% None
Hemp Extract VG Tincture, 600mg CBD, N 0.024% Isolated incident of headaches
Hemp Extract Powder Blends, 175mg CBD, M 0.000% None
Hemp Extract Powder Blends, 300mg CBD, B 0.000% None
Hemp Extract Powder Blends, 150mg CBD,
0.000% None
CC
Hemp Extract Powder Blends, 300mg CBD, C 0.000% None
These minimal complaints were primarily due to no
Hemp Extract Liposome, 1000mg CBD 0.038% effect with nominal or isolated incidents of upset
stomach and "health problems"
These minimal complaints were primarily due to no
Hemp Extract Liposome, 300mg CBD 0.010% effect with an isolated incident of severe
headaches
Hemp Extract Liposome, 100mg CBD 0.000% None
Hemp Extract Metered Dispenser, 1000mg
0.000% None
CBD
These minimal complaints were primarily due to no
effect with nominal or isolated incidents of feeling
Hemp Extract Capsules, 450mg CBD 0.038% tired, dizziness, "feeling badly," a bad reaction, the
product not working as expected, and no effect
with "additional problems"

Page 1 of 2
Complaint/AE
Product Description Percentage Complaint / Adverse Event Descriptions
of Units Sold
These minimal complaints were primarily due to no
effect with nominal or isolated incidents of
Hemp Extract Capsules, 900mg CBD 0.031% dizziness, stomach pain, diarrhea, "feeling badly,"
no effect plus feeling sick, and a bad rash with
small blisters at the top of customer's feet
Hemp Extract Balm, 125mg CBD 0.005% Isolated incidents of no effect and a bad reaction
Hemp Extract Balm, 250mg CBD 0.000% None
Hemp Extract Lip Balm, 5mg CBD 0.000% None

Page 2 of 2
Company 4

Capsules 15-35
Oil 7-60 mg Gummies 10mg Topicals
mg
June 2017-June 2019 Grand Total

Total AR (Adverse Reaction)

200 16 2 2 220
Total SAR (Serious Adverse
Reaction) 0 0 0 0 zero
Units Sold 1,397,030 331,187 14,043 478,458 2,220,718
AR rate per category 0.01% 0.00% 0.01% 0.00% 0.01%
Attachment 2 - NASC Comments to FDA

Comments for FDA Scientific Data and Information about Products Containing Cannabis
or Cannabis-Derived Compounds; Public Hearing; Request for Comments

Submitted by the National Animal Supplement Council, by e-mail and Delivered at Public
Meeting, 31 May 2019

Meeting Location:
U.S. Food and Drug Administration
White Oak Campus
10903 New Hampshire Ave
Bldg. 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
United States
Public docket FDA-2019-N-1482

On behalf of the members of the National Animal Supplement Council we appreciate the
opportunity to share our experiences and challenges with cannabis-containing and cannabis-
derived products, including information and views related to product risk to animals.
We fully support and encourage FDA to work with all States to ensure uniformity of policy and
requirements for these products. We believe that will help provide consumers with consistent,
high quality, responsible options for their animals.
The National Animal Supplement Council is the world’s leading trade association representing
companies marketing supplement products for dogs, cats and horses.
Our global membership includes raw material suppliers, contract manufacturers and marketers
of finished product brands provided in all channels of commerce. Our organization represents
over 90% of a 2.6-billion-dollar industry in the United States alone.
One of the primary differences is in the animal industry as we are regulated at 2 levels;
First, at the Federal level by the Food and Drug Administration, Center for Veterinary Medicine,
and second at the state level, typically by the state departments of agriculture or other state
agency with regulatory oversight, such as the office of the state chemist.
NASC was formed in 2001 with the objective of working cooperatively and transparently with the
Federal and state regulatory agencies, and organizations like the Association of American Feed
Control Officials to develop, define and implement policies and practices that are in the best
interests of all stakeholders, not least importantly the animals themselves.
The animal industry is a fast follow industry in that whatever trends are most popular in the
human industry will typically be in demand in the animal industry, especially with companion
animals as the humanization of pets continues. This is the case with Cannabis or Cannabis-
Derived Compounds. In fact, the popularity and demand for these products has progressed
more rapidly than any trend I have seen in my 20 years in the business.
In our brief opportunity to comment we would like to make the following primary points:

First, the regulatory agencies as well as the industry needs a clearly defined viable pathway for
the marketing of these products on both the human and animal side.
a. We believe FDA needs to provide clear guidance and definitions delineating compounds
that would be considered approved drugs as opposed to those compounds extracted or
derived from the whole plant and/or leaves and flowers from the Cannabis sativa L plant.
The resulting ingredient would contain a broad blend of constituents, including CBD,
terpenes, trace THC, and other cannabinoids.

b. We would ask the agency to move rapidly to clearly define the meaning of CBD
concentrates and isolates

c. And, we fully support THC levels being limited to less than 0.3% for Hemp

Second, do these products pose undue risk to animals? We strongly believe that systems of
continued vigilance and risk management are important. Full safety studies for every possible
product combination are not economically feasible and consistent with the agency’s Risk Based
Approach, NASC has invested significantly in what we believe is the most advanced system of
vigilance in the world for these types or products. FDA, Center for Veterinary Medicine, state
agencies, as well as international regulatory bodies, have access to data from our system. We
provide visibility to regulators for companies marketing products, provide electronic product
labels and adverse events, both serious and non-serious, which are trended and evaluated
continuously.
Specifically, for Hemp and Hemp derived compounds we have the following data from the
NASC database:

• There are 149 products currently on the market

• Some have been on the market for 10 years
• We have statistical analysis in mg. per kg. Body Weight for Dogs, Cats and Horses
• There have been 9 adverse events reported, none serious, in over 18 million
administrations in the 3 species mentioned above
While we agree that more research in all areas is needed, we very strongly believe that the data
at this time suggests these compounds, provided by responsible companies, does not pose
undue risk to dogs, cats and horses.

Finally, due to the rapidly increasing demand for these products by consumers and with the
considerable economic impact we need a solution within a reasonable time frame. 2-3 years is
simply not acceptable nor realistic given the rapidly increasing consumer demand.
To that end, NASC has initiated the formation of a task force of industry experts to help define
and present to FDA/CVM a comprehensive pathway that we believe is both viable and
responsible for all stakeholders. We will be reaching out to FDA/CVM for further discussions
with action plans, milestones and timeframes.
As we proceed, we are in full agreement with the agency’s position of taking action against
irresponsible companies with obvious violations for egregious claims and irresponsibly marketed
products. While we have an excellent working relationship with the agency, we are
disappointed that more action has not been taken against such irresponsible companies.

In closing I would add, that the majority of both the human and animal industries are responsible
companies and we also have a duty to educate our downstream business partners about
irresponsible and opportunistic participants in our industry.
Thank you again for the opportunity to provide comments.

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2019.07.16 US Hemp Roundtable FDA Comments

Uploaded by

2019.07.16 US Hemp Roundtable FDA Comments

Uploaded by

e: info@hempsupporter.

A. Health and Safety Risks

1. Safety of CBD and Hemp-Derived Ingredients

a. Additional Product Safety Data for Humans and Animals

• “There are 149 products currently on the market

5. Safety Monitoring for Adverse Events

7. General Use in Food

8. Impact of Commercial Availability of Non-Drug CBD Products on Incentives for Drug

B. Manufacturing and Product Quality

1. Safety Standards Related to Manufacturing, Processing, and Holding Hemp-Derived

2. Standards and Processes to Ensure Manufacturing Quality and Consistency of Products

3. Validated Analytical Testing to Support the Manufacturing of Safe and Consistent

4. Standardized Definitions for Ingredients

5. Functional Purposes of Hemp-Derived CBD in Food

C. Marketing, Labeling, and Sales of Hemp and CBD Products

2. State Approaches to Regulating CBD-Containing Food Products

Summary of Recommendations to FDA:

Cambell, T. et al., Cannabinoids in Pediatrics, J. Pediatr. Pharmacol. Ther., (2017), 22(3).

Miller, et al., A Systemic Review on the Pharmacokinetics of Cannabidiol in Humans, Frontiers in

WHO, 2018. CBD, Critical Review Report: https://www.who.int/medicines/access/controlled-

Total AR (Adverse Reaction)

15-20 mg CBD Supplement; 4,638

10-15 mg CBD Supplement; 2,724

15-20 mg CBD Supplement; 5,657

10-15 mg CBD Supplement; 3,285

15-20mg CBD Capsules; 104,200

5-7mg CBD Supplement; 10,677

15-20mg CBD Softgels; 119,998

25-30mg CBD Capsules; 10,429

5-7 mg CBD Softgels; 16,326

5-7 mg CBD Softgels; 20,019

10-15mg CBD Caps; 88,717

5-7 mg CBD Drops; 52,226

5-7 mg CBD Drops; 79,004

3-5 mg CBD Drops; 12,022

1-3 mg CBD Drops; 21,511

1-3 mg CBD Drops; 15,822

1-3 mg CBD Drops; 18,045

5-7 mg CBD Drops; 8,649

3-5 mg CBD Drops; 7,598

3-5mg CBD Spray; 5,990

Summary of Data Provided

Total AR (Adverse Reaction)

• There are 149 products currently on the market

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