Introduction
On April 3, 2019, the US Food and Drug Administration (FDA) announced a public
hearing on May 31, 2019 and a call for written comments on the topic of cannabis and
cannabis-derived compounds.
1
Kevin Chapman, MD, spoke on behalf of the American Epilepsy Society (AES) at
the public hearing. Transcripts of comments, including those by Dr Chapman, are
available through the FDA website.
2
Additionally the AES submitted written comments on July 16, 2019, in response to the
FDA call for Scientific Data and Information about Products Containing Cannabis or
Cannabis-Derived Compounds.
1
At the request of the AES Board of Directors, official AES written comments
were authored by Council on Clinical Activities Chair, Timothy Welty, PharmD, along
with Edward Faught, MD, Kevin Chapman, MD, and Robert Kotloski, MD. These
representatives were selected for their diverse expertise on the topic and freedom
from conflicts of interest. These comments, approved by the AES Board, align with
the AES Position Statement on Cannabis as a Treatment for Patients with Epileptic
Seizures, Revised February 19, 2019
3
and provide additional, selected supporting documentation on related key
points of interest to FDA. The AES comments, along with other public comments
submitted to FDA, are also publicly available via the FDA online docket.
4
After the public comment period closed, FDA issued statements highlighting key
outstanding questions and points of concern that include misleading and false claims.
5
The FDA reiterated its continuing evaluation of regulatory frameworks for
products containing cannabis and cannabis-derived compounds and its intent to
approach the outstanding questions “as a science-based regulatory agency committed
to our mission of protecting and promoting public health.”
6
As a service to AES members, the official AES written comments are being published
in
Epilepsy Currents. Information provided in these comments
should be helpful to AES members in making decisions about cannabis or
cannabis-derived compounds and in educating patients and caregivers on these
products.
About the AES
The AES appreciates the opportunity to provide comments to the FDA on questions
related to cannabidiol (CBD) and cannabis-derived compounds. As the professional
society for health-care professionals committed to epilepsy research and care of
individuals afflicted with epilepsy, the AES consists of approximately 4000 members.
The membership is composed of physicians, nurses, advanced practice providers,
pharmacists, psychologists, social workers, and basic scientists focused on
epilepsy. Our commitment is to research and deliver evidence-based care to
individuals with epilepsy.
American Epilepsy Society Position on CBD and Cannabis-Derived Compounds
At the beginning of 2019, the AES revised its position statement on CBD and
cannabis-derived compounds. The full statement is available in Supplemental Appendix A
(available online).
3
Basically, our position is that pharmaceutical grade CBD demonstrates
moderate efficacy in specific types of seizures, that CBD does have important
adverse effects, that CBD has several important drug interactions, and that further
research is needed on CBD and cannabis-derived compounds. While outside the purview
of the FDA, we advocate for the Drug Enforcement Agency to reschedule CBD and
cannabis-derived compounds to allow for increased research of these products in
epilepsy and other diseases.
Given the current patchwork of legislation and regulations at the federal, state,
and
local levels, the AES recognizes that there is great confusion in a number of areas
related to these products. Patients are uncertain about the legal status of products
and have poor to no understanding of the products they are purchasing or consuming.
Health-care professionals lack sufficient information about the various products
flooding the market, are uncertain of how to advise patients on CBD and
cannabis-derived compounds, are unaware of products that their patients may be
consuming, and are unable to appropriately monitor patients taking CBD or
cannabis-derived compounds due to these factors. The public is confused about the
true scientific evidence for the safety and efficacy of CBD and cannabis-derived
compounds in epilepsy or other diseases.
The AES advocates that CBD and cannabis-derived compounds be viewed as drugs, as
defined by the FDA. This would place CBD and cannabis-derived compounds under the
full regulatory control of the FDA. It would ensure that CBD and cannabis-derived
compounds are marketed based on the highest scientific standards for safety and
efficacy and ensure that these products are produced under the highest manufacturing
standards. However, the AES also recognizes that such action might jeopardize
patient access to some CBD products that our patients believe to be beneficial in
controlling their epilepsy. If steps are taken to regulate CBD and cannabis-derived
compounds as drugs, the FDA should consider ways to ensure that individuals with
epilepsy are not denied access to products they believe to be beneficial or they can
be easily transitioned to FDA-approved products without suffering adverse financial
consequences.
With this perspective, the AES provides the following comments in response to the
questions on scientific data and information about products containing cannabis or
cannabis-derived compounds posed by the FDA for the public hearing and request for
comments.
Significant Health and Safety Risk Considerations
Adverse effects
While there is a general public perception that CBD is without risk, this is
not entirely true. Adverse effects of CBD reported in clinical trials with
Epidiolex®, which are more common than with placebo, include somnolence,
nausea, diarrhea, and poor appetite; 5% to 14% of patients in clinical
trials stopped taking CBD because of adverse effects. It is likely that
these effects are dose-dependent. Epidiolex® was also associated with a
higher risk of hepatotoxicity necessitating recommended scheduled liver
function testing in patients starting the medication. The recommended dosing
for Epidiolex® is 10 to 20 mg/kg, but some trials used higher doses of 25
mg/kg body weight, with a maximum of 50 mg/kg.
We suggest that the FDA consider a recommended maximum daily dose of CBD from
all nonprescription sources. Perhaps a nonprescription dose limit of 5
mg/kg/d would be appropriate. This is at the lower range of effective doses
in clinical trials of CBD for epilepsy. Since toxicity is likely
dose-related (see below), higher doses should be taken only under medical
supervision. In addition, ingesting CBD with fatty meals, as opposed to
ingestion without food, may increase its absorption and blood levels up to 4 times.
7
Therefore, if an individual were to take a dose of 5 mg/kg/d with a
fatty meal, their level may be similar to the upper limit dosing of 20
mg/kg/d Epidiolex®.
Besides the concern with a maximal dose of CBD, there is an additional
concern related to the composition of many oral CBD products. Being
essentially insoluble in water, many oral preparations of CBD are compounded
in an oil (eg, olive, peanut, cottonseed). Higher doses of CBD can expose
patients to a higher load of oil leading to increased gastrointestinal or
other adverse effects. Many other cannabis-derived compounds are also
insoluble in water, raising similar concerns to oral preparations of CBD.
Also, as noted earlier, the absorption of CBD is increased 4- to 5-fold when
taken with a high fat content meal. This difference in absorption would make
a 5 mg/kg/d nonprescription dose similar to the maximum recommended
prescription dose of CBD. This approach to nonprescription dosing of CBD is
consistent with the FDA’s approach to doses of other nonprescription
medications.
Drug interactions
Cannabidiol is an inhibitor of the hepatic enzymes, cytochrome P450 3A4 and
2C19. These enzymes are involved in the metabolism of many commonly used
medications. Drug interactions do occur with a variety of medications, which
could be clinically significant. Supplemental Appendix B (available online) presents
literature search results illustrating the variety of potential drug
interactions.
Serum levels of the following antiseizure medications rise when CBD is taken
with them: desmethylclobazam (an active metabolite of clobazam), topiramate,
zonisamide, rufinamide, and eslicarbazepine. When CBD is taken with
valproate, there is an increased incidence of abnormally elevated liver
function tests, although it is not known whether there is an increased risk
of liver dysfunction. Valproate and topiramate are widely used for the
prophylaxis of migraine and valproate is used in psychiatry, so the possible
interactions extend to nonepilepsy populations as well.
8
Many medications undergo metabolism in the liver through these enzyme systems
and may be associated with altered metabolism that is clinically
significant. For example, there are multiple reports of an interaction
between the critical drug warfarin and CBD, resulting in a greatly increased
risk of bleeding.
9,10
Likewise, there is the potential for interactions that alter the absorption
and metabolism of CBD. It is well-documented that taking CBD orally with a
fatty meal results in a 4- to 5-fold increase in CBD absorption and concentrations.
7
Other drugs may inhibit or induce the metabolism of CBD, resulting in
increased toxicity or decreased efficacy.
Outside of the limited understanding of CBD interactions, little is known
about drug–drug or drug–food interactions with cannabis-derived products.
Given what is known about CBD interactions, it is likely that interactions
with cannabis-derived products occur.
Documented and potential drug–drug and drug–food interactions with CBD or
cannabis-derived compounds necessitate management of CBD and
cannabis-derived compounds under the supervision of a physician and other
health-care professionals. In addition, the public should be educated on
these interactions and their harmful effects.
Pregnancy and pediatric risk
There is limited information about the effects of cannabis-derived products
on the developing brain. Brain development starts early in pregnancy, often
before the mother is aware that she is pregnant. With 2-5% of mothers
self-reporting marijuana use during pregnancy
11
and a greater availability of marijuana, there are concerns that an
even larger number may utilize cannabis-derived products during the earliest
critical stages of development. Limited studies in neonates following in
utero marijuana exposure are inconsistent but raise concern for fetal growth
and early neonatal behaviors.
11
Longitudinal studies of marijuana-exposed neonates suggested concerns
for neurodevelopmental and behavioral outcome, although confounders such as
cigarette use may question an independent effect. There is limited to no
data regarding cannabis-derived products in this same population. Similarly,
chronic marijuana use in adolescents and young adults has demonstrated
alterations in functional magnetic resonance imaging compared to controls.
12
While there are limited data on long-term outcomes in
cannabis-derived products, multiple studies raise concerns about potential
negative effects on neurocognitive and behavioral development over time.
Highlighting these potential risks to the public in this vulnerable
population through labeling and supervision by their physician may help
prevent potentially harmful exposure.
Increased risk of overdose
Following legalization of marijuana products in Colorado, there has been a
34% increase in unintended pediatric exposures per year from 2009 to 2015.
13
Edible products were responsible for 52% of cases, while in 9%, the
product was not in child-resistant containers. Similar findings were found
in Oregon following legalization with 253 cases of acute cannabis toxicity
over a 16-month period. Children and teens comprised 44% of patients with
the majority unintentionally ingesting edible products. Symptoms in children
were typically related to excessive sedation, while adults experienced
neuroexcitation (anxiety, hallucinations, agitation, etc). Eight patients
required intensive care and 1 patient died. Ingestion of concentrated
products, such as liquid concentrates or resins, was associated with a
higher rate of intensive care unit admission and intubation.
14
Packaging and labeling strategies need to be implemented to reduce
unintended exposure to cannabis-derived products, particularly in children.
Concentrated products warrant additional warnings of adverse effects.
Potential substitution for effective treatment
Given the perception that cannabis-derived products are more natural, there
is real concern that patients and caregivers may substitute medications with
scientifically proven medical benefit for cannabis-derived products with
unsubstantiated claims. A recent study demonstrated that nearly 50% of
subjects had substituted cannabis for a prescription medication.
15
With social media allowing for personal stories extolling marijuana
products for life-threatening diseases, such as epilepsy and cancer, we need
to implement strategies highlighting the risks of avoiding or demonizing
scientifically proven or FDA-approved treatments. One example is a
cannabis-derived product sold online purportedly to abort seizures:
https://www.trulieve.com/shop/nasal-spray.
16
Given the substantial risk of injury from prolonged seizures and
clear data supporting earlier treatment using benzodiazepines for first-line
therapy to abort seizures, using cannabis-derived products in this manner
is, at best, misguided and more likely to be negligent.
Product Variability and Lack of Standards in Manufacturing and Product
Quality
In the current environment, CBD and cannabis-derived compounds are available
through 3 different marketing avenues. There is the FDA-approved CBD product,
Epidiolex®, other FDA-approved cannabis-derived compounds (eg, Marinol, Syndros,
Cesamet), state-authorized CBD or cannabis-derived compounds, and artisanal or
completely unregulated products.
Types of available products
As noted, there are FDA-approved CBD and cannabis-derived compounds that are
available to patients through the traditional prescriptive process. We will
not comment on these products, as they meet FDA standards and
regulation.
Several states, like Minnesota (https://www.health.state.mn.us/people/cannabis/index.html),
17
Iowa (https://idph.iowa.gov/cbd/Medical-Cannabidiol-Board),
18
and Ohio (https://medicalmarijuana.ohio.gov/)
19
have developed their own programs for authorization of products of
CBD or cannabis-derived compounds. Laws and regulations for these programs
and the products vary greatly from state to state, with Iowa being one example.
20
However, the programs usually require some type of physician
authorization for a patient to obtain CBD or cannabis-derived compounds;
state authorization of the CBD or cannabis-derived compound products
available to patients; state monitoring of quality, purity, and
manufacturing of the CBD or cannabis-derived compound products; governance
or oversight of the cannabis program by a medical and regulatory board; and
use of state licensed or authorized dispensaries for distribution of CBD and
cannabis-derived compounds. Minnesota has one of the longest records in
operating a state-authorized cannabis program and has a good amount of data
on the use of cannabis for various medication conditions.
Publicly available data on the use of CBD and cannabis-derived compounds in
Minnesota are available at https://www.health.state.mn.us/people/cannabis/about/medicalcannabisstats.html.
21
We were able to obtain data from the Iowa CBD program, and these data
are presented in Appendix
A. It is important to note from the Iowa data that the most
frequently purchased products were those containing higher amounts of
tetrahydrocannabinol than CBD. Reasons for this observation are unclear but
are most likely due to a lack of understanding about the differences between
CBD and tetrahydrocannabinol, lack of effect from CBD, or individuals being
more interested in obtaining tetrahydrocannabinol than in getting CBD. While
not necessarily operating in accordance with FDA guidance and regulations,
the state-authorized cannabis programs do appear to provide some assurance
to the public that CBD and cannabis-derived compounds obtained through these
programs have achieved some standard for content and purity of the products.
These programs can also be a rich source of good quality data on the use of
products of CBD and cannabis-derived compounds
The other way in which patients may obtain products of CBD or
cannabis-derived compounds is through what may be termed artisanal products.
At the current time, these products are produced and sold with little or no
regulatory control. The products are commonly available in dispensaries
operated in states that do not regulate the cannabis industry or through
Internet sites and sources. Even in states that have attempted to regulate
CBD and cannabis-derived compounds, the artisanal sources of these products
may be available to patients.
Product standards and assays
Multiple assay methods for CBD and cannabis-derived compounds are available
in the published medical literature. Various assay techniques have been used
to detect CBD, cannabis-derived compounds, impurities, and degradation
products. Examples of CBD identification and analysis techniques are
summarized in a World Health Organization (WHO) 2018 report.
22
Efforts are underway to develop highly sensitive and selective
analytic methods for qualitative and quantitative determination of cannabinoids.
23
However, none of these assays have been tested and validated to be
the standard assay for product content, purity, and stability. To date, the
United States Pharmacopeia has not set an official standard assay and
quality standard for CBD or cannabis-derived compounds. Without this
standard, it is impossible to ensure the content, quality, and purity of
products of CBD or cannabis-derived products.
Additionally, the FDA has not set standards that regulate the cultivation,
growth, or manufacturing of products of CBD or cannabis-derived compounds.
To ensure the quality and consistency of CBD or cannabis-derived compounds,
regulation of production must begin with the growth and cultivation of
plants that are used for production of the final products. Dealing with
botanical-based products presents a number of challenges to ensure
consistent content of active ingredients. One source that provides excellent
recommendations and guidance on this aspect of use of botanical products is
the WHO Guidelines on Good Agricultural and Collection Practices for
Medicinal Plants (GACP).
24
Although this document is somewhat dated, it does highlight the
issues associated with medicinal plants and can form the basis for
development of regulations and guidance on agricultural and collection
practices as part of oversight of the production of cannabis-based drugs or
other botanical sources of phytocannabinoids. We note that the FDA has a
guidance document on Botanical Drug Development,
25
but this does not appear to include regulations around the
agricultural and collection practices of botanical products, such as CBD or
cannabis-derived compounds. Without these regulations on the agricultural
and collection practices, it is impossible to truly ensure the quality and
content of products of CBD or cannabis-derived compounds.
Manufacturing practices
Vital to access and availability of high-quality, consistent and reliable
products of CBD and cannabis-derived compounds is the application of Good
Manufacturing Practice (GMP) to their manufacturing and production. The FDA
does have well-developed standards for drug products.
26
While these regulations address the issues surrounding the
manufacturing and production of drug products, there are 2 concerns
regarding GMP as they apply to products of CBD and cannabis-derived
compounds. The first is that many of the regulations are dependent on
standard, validated assays for drug product, content, purity, and stability.
As noted above, standard assays for products of CBD and cannabis-derived
compounds have not been established. The first step in applying GMP to
production of products of CBD and cannabis-derived products is setting
standard assay techniques and parameters. A second concern is evaluating GMP
standards in relationship to botanical products, and specifically to CBD and
cannabis-derived products, to ensure that any supporting documents,
explanations, and expectations account for the unique issues in the
manufacturing and production of these drugs.
Additionally important to the manufacturing of CBD and cannabis-derived
compounds is the health and safety of individuals who work with these
products. There have been several reports in the literature concerning the
health and welfare of individuals who work with cannabis and hemp products.
27,28
While generally outside the jurisdiction of the FDA and the direct interests
of the AES, this issue increases the concern with unregulated manufacturing
of CBD and cannabis-derived compounds.
Variability of products
The criticality of addressing product variability issues cannot be
overemphasized. As noted in multiple published reports, currently available
products of CBD and cannabis-derived compounds are frequently mislabeled,
misbranded, or adulterated.
29
-32
Artisanal products were most tested in this regard. Many CBD products
contain much different amounts of CBD than what are noted on the label,
usually lower quantities of CBD. Several of these CBD products contained
other cannabinoids, including tetrahydrocannabinol, in addition to CBD. In
many cases, the quantities of the other cannabinoids were at levels that
could produce a pharmacological effect. Additionally, many of the products
were contaminated with microbes, fungi, herbicides, pesticides, heavy
metals, and other pharmaceutical products. The extent of the documented
problems with currently available products is sufficient to advise patients
and caregivers to avoid purchasing and using the artisanal products of CBD
and cannabis-derived compounds.
In summary, the AES believes that the highest standards of assay techniques,
agricultural practices for botanical products, GMPs, and other measures to
ensure the quality and consistency of products of CBD and cannabis-derived
products must be implemented. Without this surveillance and regulation, the
risk of harm and confusion to the public is great.
Need for Better Accuracy and Consistency in Marketing/Labeling/Sales
Based upon the above concerns, our clinical experience, and the regulatory
measures of states, we advise that labeling for all cannabis and
cannabis-derived compounds contains accurate measures of cannabinoid ingredients
including CBD, delta-9-tetrahydrocannabinol cannabidiolic acid, and
tetrahydrocannabinolic acid, with accurate concentrations provided in
milligrams, for both the entire package and per dose/serving.
The intended route of administration should be clearly stated on the label. This
information is critical to the safe use of the product by the consumer and for
appropriate counseling by the physician. If third-party testing is reported, the
detailed analysis should be available to the consumer. Inclusion of a batch
number would allow for detailed tracking of products.
Regarding the packaging itself, given the concern for accidental overdose,
especially in children, we recommend childproof packaging and limitation of the
single packaged dose to 250 mg (equal to the starting dose of 5 mg/kg for a
50-kg individual in clinical trials of CBD for childhood epilepsies). This
amount is about half of the minimal effective dose and is consistent with
current FDA practices for nonprescription versions of prescription drugs. For
nonprescription versions, the container should not contain more than a 30-day
supply.
Selected labels in Supplemental Appendix C (available online) illustrate some of
the inconsistencies, inaccuracies, and confusion resulting from current labeling
regulation for CBD and cannabis-derived compounds that underlie AES concerns and
prompt its recommendations.
Regarding potential adverse effects both directly and indirectly from cannabis
and cannabis-derived compounds, we advise labeling should include mention of
hepatotoxicity, depression, nausea, diarrhea, somnolence, and appetite
disturbance, as well as interactions with multiple medications. Given the
frequent use of cannabis and cannabis-derived compounds for the treatment of
epilepsy, the abundant interactions with antiseizure medications should be
highlighted. Labeling should advise the consumer to discuss the use of the
product with a pharmacist or physician. Labeling should also include warnings
for use in children and in women who are pregnant, planning to become pregnant,
or breastfeeding.
AES recommends that FDA actively encourage health-care providers and the public
to report all overdoses, toxicity, and adverse effects via FDA’s MedWatch program
33
at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.
Additionally, problems with labeling can also be reported to the Institute for
Safe Medication Practices
34
at https://www.ismp.org/report-medication-error.
One review
35
summarizes public health regulation best practices lessons from tobacco
control that may be worthy of FDA consideration in the context of cannabis and
cannabis-related compounds regulation. Recommendations include prominent warning
labels, rotating health warnings using pictorial content, plain packaging that
curtails label use as a marketing tool, reducing appeal to minors, and limiting
potency on products easily confused with non-cannabis products.
Finally, labeling should clearly state that the product is not FDA approved, and
no claims of health benefits of these untested products should be allowed.
Conclusion and Recommendations
There is sufficient evidence to argue for regulation of CBD and cannabis-derived
compounds as drugs by the FDA. The AES believes that these compounds need to be
under the full regulatory control of the FDA and that distribution should be limited
to the well-developed legend drug process. While drug regulation is desired, in the
interim, the following equally important steps should be taken to assure continuous
and safe access to CBD products for patients who are currently benefiting from
them.
Until regulation of CBD and cannabis-derived compounds as drug is accomplished, AES
recommends that FDA implements the following steps to help ensure patient and
consumer safety:
Require labeling of common and serious adverse effects and symptoms of
overdose.
Require label warnings about interactions with other medications.
Require label warnings with considerations for special populations such
as children and women who are pregnant, planning to become pregnant, or
breastfeeding.
To enable health professionals to monitor and manage drug interactions
and be alerted to potential symptoms of overdose or toxicity in
patients, require a label warning that encourages consumers to report
use of CBD and cannabis-derived products to their physicians; for
example, “Please inform your physician if you are taking this
medication.”
Encourage the public and health-care professionals to report problems
with CBD and cannabis-derived compounds to the FDA MedWatch program
33
at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
and to report errors and problems with labeling to the Institute for
Safe Medication Practices
34
at https://www.ismp.org/report-medication-error.
Determine a recommended maximum daily dose for nonprescription use.
Require clear and accurate labeling of dose or strength per unit.
Require clear disclosure of the amounts of each cannabinoid in a
product.
Develop standards for product quality assay techniques.
Enforce the highest GMP levels possible.
Thank you for the opportunity to provide comments as FDA considers regulatory options
and weighs the many significant factors involved in ensuring safe and effective use
of cannabis and cannabis-related products including CBD. American Epilepsy Society
remains available to answer questions, provide additional information, offer
clinical or scientific expertise, or otherwise serve as a resource to FDA.
Supplemental Material
Supplemental Material,
03-Appendix_A-2019-07-16-American_Epilepsy_Society-FDA_Comments-CBD -
American Epilepsy Society (AES): Written Comments to Norman E. “Ned”
Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug
Administration (FDA), Department of Health and Human Services (HHS): on
Docket ID# FDA-2019-N-1482, Scientific Data and Information about
Products Containing Cannabis or Cannabis-Derived Compounds; Public
Hearing; Request for Comments: Submitted on: July 16,
2019
Click here for additional data file.
Supplemental Material,
03-Appendix_A-2019-07-16-American_Epilepsy_Society-FDA_Comments-CBD for American
Epilepsy Society (AES): Written Comments to Norman E. “Ned” Sharpless, MD,
Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA),
Department of Health and Human Services (HHS): on Docket ID# FDA-2019-N-1482,
Scientific Data and Information about Products Containing Cannabis
or Cannabis-Derived Compounds; Public Hearing; Request for
Comments: Submitted on: July 16, 2019 by Timothy E. Welty, Kevin E.
Chapman, R. Edward Faught and Robert J. Kotloski in Epilepsy Currents
Supplemental Material
Supplemental Material,
04-Appendix_B-2019-07-16-American_Epilepsy_Society-FDA_Comments-CBD_(1) -
American Epilepsy Society (AES): Written Comments to Norman E. “Ned”
Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug
Administration (FDA), Department of Health and Human Services (HHS): on
Docket ID# FDA-2019-N-1482, Scientific Data and Information about
Products Containing Cannabis or Cannabis-Derived Compounds; Public
Hearing; Request for Comments: Submitted on: July 16,
2019
Click here for additional data file.
Supplemental Material,
04-Appendix_B-2019-07-16-American_Epilepsy_Society-FDA_Comments-CBD_(1) for
American Epilepsy Society (AES): Written Comments to Norman E. “Ned” Sharpless,
MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration
(FDA), Department of Health and Human Services (HHS): on Docket ID#
FDA-2019-N-1482, Scientific Data and Information about Products
Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request
for Comments: Submitted on: July 16, 2019 by Timothy E. Welty,
Kevin E. Chapman, R. Edward Faught and Robert J. Kotloski in Epilepsy
Currents
Supplemental Material
Supplemental Material,
06-Appendix_C-2019-07-16-American_Epilepsy_Society-FDA_Comments-CBD -
American Epilepsy Society (AES): Written Comments to Norman E. “Ned”
Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug
Administration (FDA), Department of Health and Human Services (HHS): on
Docket ID# FDA-2019-N-1482, Scientific Data and Information about
Products Containing Cannabis or Cannabis-Derived Compounds; Public
Hearing; Request for Comments: Submitted on: July 16,
2019
Click here for additional data file.
Supplemental Material,
06-Appendix_C-2019-07-16-American_Epilepsy_Society-FDA_Comments-CBD for American
Epilepsy Society (AES): Written Comments to Norman E. “Ned” Sharpless, MD,
Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA),
Department of Health and Human Services (HHS): on Docket ID# FDA-2019-N-1482,
Scientific Data and Information about Products Containing Cannabis
or Cannabis-Derived Compounds; Public Hearing; Request for
Comments: Submitted on: July 16, 2019 by Timothy E. Welty, Kevin E.
Chapman, R. Edward Faught and Robert J. Kotloski in Epilepsy Currents