cbdMD Statement for the Record - Comer Hearing
Sibyl Swift, Ph.D.
cbdMD
Chief Science Officer & VP Regulatory Affairs
Statement for the Record: FDA Inaction on Regulatory Pathway for Cannabinoids
Thank you, Chairperson Comer, for allowing me to present a statement on behalf of cbdMD.
At cbdMD, we are keenly aware there are rules and guidelines for providing safe dietary
supplement products to consumers under the Dietary Supplement Health and Education Act
(DSHEA). We have adhered to the four corners of those guidelines through our commitment to
third party cGMP certifications, proper labelling with adequate instructions for use, adverse
event tracking and reporting, and independent safety testing of our hemp derived cannab inoid
ingredient. We go the extra mile by publicly posting current Certificates of Analysis detailing
the chemical analysis of every product we sell, which is something no other dietary supplement
does. With regards to safety and efficacy, we have made significant investment in both safety
and clinical studies for efficacy. We have successfully navigated the regulatory submission
process in other countries (UK, EU, several Latin American countries). Despite our wealth of
data proving the safety and efficacy of our products, we have attempted to work through this
process with the US FDA to no avail.
The Agency has posted guidance documents, held scientific meetings, and opened a docket for
the submission of cannabidiol safety data. Despite all of these efforts, they continue to ask for
more data. The multi-system safety study we executed on our broad spectrum extract was more
than sufficient for the rigorous review in the UK, and was done to the highest global standard
known as OECD. Our trade association, the Natural Products Association, filed a Citezen’s
Petition on our behalf, which pointed out that extract of cannabis was sold in commerce in the
United States and listed by the United Stated Pharmacopeia in the late 1800’s, prior to the shift
to prohibit cannabis in this country, and most importantly requesting the data compiled in our
safety study be provided the same opportunity for review in the U.S. as any other botanically
derived product intended for consumption as a dietary supplement. Our study explored many
of the endpoints for which FDA has expressed concern, including reproductive toxicology and
genetoxicology. We strongly argued that CBD is not drug precluded and is in fact, a new dietary
ingredient that can be regulated under current authorities afforded under DSHEA. FDA issued
a public statement in January whereby they summarily denied the three Citizen’s Petitions
filed to date on CBD, including ours. The statement included messaging around CBD and their
concerns shifted from safety alone to include cannabinoid’s potential activity in the body.
Cannabinoids are not the first constituent of a botanical dietary ingredient to exhibit
pharmacological activity. Food is well-known for having biochemical and physiological effects
on the cells, tissues, and organs, otherwise known as pharmacological effects. In fact, the sole
purpose of a dietary supplement in the diet is to have pharmacological activity in the human
body. Let’s be very clear and honest here and state for the record that a consumer would have
no reason to buy a dietary supplement unless it had pharmacological activity and the FDA
clearly knows this. Otherwise, it would just be snake oil. Some of the well known ingredients
which have a long history of use in dietary supplements while exhibiting pharmacological
activity including: caffeine, EGCG, EPA/DHA, carnitine, N-acetyl cystine, and quercetin.
Honey can exhibit anti-inflammatory effects through toll-like receptors. Paracelsus said it best,
cbdMD
Chief Science Officer & VP Regulatory Affairs
Statement for the Record: FDA Inaction on Regulatory Pathway for Cannabinoids
Thank you, Chairperson Comer, for allowing me to present a statement on behalf of cbdMD.
At cbdMD, we are keenly aware there are rules and guidelines for providing safe dietary
supplement products to consumers under the Dietary Supplement Health and Education Act
(DSHEA). We have adhered to the four corners of those guidelines through our commitment to
third party cGMP certifications, proper labelling with adequate instructions for use, adverse
event tracking and reporting, and independent safety testing of our hemp derived cannab inoid
ingredient. We go the extra mile by publicly posting current Certificates of Analysis detailing
the chemical analysis of every product we sell, which is something no other dietary supplement
does. With regards to safety and efficacy, we have made significant investment in both safety
and clinical studies for efficacy. We have successfully navigated the regulatory submission
process in other countries (UK, EU, several Latin American countries). Despite our wealth of
data proving the safety and efficacy of our products, we have attempted to work through this
process with the US FDA to no avail.
The Agency has posted guidance documents, held scientific meetings, and opened a docket for
the submission of cannabidiol safety data. Despite all of these efforts, they continue to ask for
more data. The multi-system safety study we executed on our broad spectrum extract was more
than sufficient for the rigorous review in the UK, and was done to the highest global standard
known as OECD. Our trade association, the Natural Products Association, filed a Citezen’s
Petition on our behalf, which pointed out that extract of cannabis was sold in commerce in the
United States and listed by the United Stated Pharmacopeia in the late 1800’s, prior to the shift
to prohibit cannabis in this country, and most importantly requesting the data compiled in our
safety study be provided the same opportunity for review in the U.S. as any other botanically
derived product intended for consumption as a dietary supplement. Our study explored many
of the endpoints for which FDA has expressed concern, including reproductive toxicology and
genetoxicology. We strongly argued that CBD is not drug precluded and is in fact, a new dietary
ingredient that can be regulated under current authorities afforded under DSHEA. FDA issued
a public statement in January whereby they summarily denied the three Citizen’s Petitions
filed to date on CBD, including ours. The statement included messaging around CBD and their
concerns shifted from safety alone to include cannabinoid’s potential activity in the body.
Cannabinoids are not the first constituent of a botanical dietary ingredient to exhibit
pharmacological activity. Food is well-known for having biochemical and physiological effects
on the cells, tissues, and organs, otherwise known as pharmacological effects. In fact, the sole
purpose of a dietary supplement in the diet is to have pharmacological activity in the human
body. Let’s be very clear and honest here and state for the record that a consumer would have
no reason to buy a dietary supplement unless it had pharmacological activity and the FDA
clearly knows this. Otherwise, it would just be snake oil. Some of the well known ingredients
which have a long history of use in dietary supplements while exhibiting pharmacological
activity including: caffeine, EGCG, EPA/DHA, carnitine, N-acetyl cystine, and quercetin.
Honey can exhibit anti-inflammatory effects through toll-like receptors. Paracelsus said it best,
“The dose makes the poison” and dietary supplements are not intended to be ingested in a dose
that is pharmaceutical, but will absolutely exhibit pharmacological effects, according to this
definition. The Structure-Function Claim Notification (SFCN) is a well-established, statutorily-
mandated process by which dietary supplement manufacturers submit statements that they
have used in marketing and the studies they have completed that support those statements.
This has been the process for demonstrating the efficacy of botanically derived dietary
supplements for over 30 years and is well within the current authorities of the FDA to require
for hemp derived cannabinoids. Consumers purchase dietary supplements, rather than
consume the food from which it was extracted, because the supplements exhibit activity in
support of health and wellness greater than any benefit derived from food or in a form that is
more convenient to obtain the pharmacological benefits. Hemp-derived cannabinoids are not
special or different from any other botanical ingredient. They have a long history of use in food
and traditional medicine. In the very low milligram levels commensurate with dietary
supplements, they are safe and efficacious.
For FDA to flag CBD and cannabinoid products as potentially dangerous due to their
pharmacological activity, and disseminate false and misleading statements, is disingenuous at
best and borderline fraudulent at worst. There are hundreds of unique new dietary ingredient
notifications for botanical ingredients that did not confuse FDA when they presented unique
activity on the structure of function of the body. I know this for a fact as I worked in the Office
of Dietary Supplement Programs for over 5 years, reporting directly to the Ofiice Director, and
I worked on these issues. FDA has essentially presented the unsupportable position that
cannabinoids are a new ingredient that does not fall into their defined regulatory categories.
Cannabinoids did not come from an alien planet or get recently discovered in a cave. They are
constituents of a plant that has been safely consumed for tens of thousands of years. There is a
well-established process the FDA manages under current authorities for demonstrating the
safety of botanically derived dietary supplements and submitting notifications to the Agency
when a dietary supplement impacts the structure or function of the body. We consume dietary
supplements because they have an effect on the body that we could not achieve with our diet
alone.
As mentioned, we have a robust and adequate regulatory framework in place now under
DSHEA to handle all hemp extracted cannabinoids, including CBD and THC, once the Agency
properly recognizes them for what they are – well known and characterized constituents of an
old dietary ingredient (extract of cannabis) that is exempted from drug exclusion and eligible
for regulation under the current authorities in DSHEA . By taking a “drug” view of botanical
extracts and applying an extremely overbroad interpretation of drug exclusion, the Agency is
denying consumers access to safe, inexpensive, and effective alternatives to drug products. This
same Agency that should be focused on protecting the public health is instead allowing bad
actors to continue operating and proliferate the amount of dangerous products in commerce,
when they have regulations in place now to effectively control this market.
The public comments from the FDA with regards to drug exclusion and the status of
cannabidiol (CBD) as a dietary ingredient are merely statements of opinion and do not have
the force of law until there is an enforcement action against the ingredient CBD by the Agency
or a ruling by a court in an action to interpret the scope and application of drug exclusion.
definition. The Structure-Function Claim Notification (SFCN) is a well-established, statutorily-
mandated process by which dietary supplement manufacturers submit statements that they
have used in marketing and the studies they have completed that support those statements.
This has been the process for demonstrating the efficacy of botanically derived dietary
supplements for over 30 years and is well within the current authorities of the FDA to require
for hemp derived cannabinoids. Consumers purchase dietary supplements, rather than
consume the food from which it was extracted, because the supplements exhibit activity in
support of health and wellness greater than any benefit derived from food or in a form that is
more convenient to obtain the pharmacological benefits. Hemp-derived cannabinoids are not
special or different from any other botanical ingredient. They have a long history of use in food
and traditional medicine. In the very low milligram levels commensurate with dietary
supplements, they are safe and efficacious.
For FDA to flag CBD and cannabinoid products as potentially dangerous due to their
pharmacological activity, and disseminate false and misleading statements, is disingenuous at
best and borderline fraudulent at worst. There are hundreds of unique new dietary ingredient
notifications for botanical ingredients that did not confuse FDA when they presented unique
activity on the structure of function of the body. I know this for a fact as I worked in the Office
of Dietary Supplement Programs for over 5 years, reporting directly to the Ofiice Director, and
I worked on these issues. FDA has essentially presented the unsupportable position that
cannabinoids are a new ingredient that does not fall into their defined regulatory categories.
Cannabinoids did not come from an alien planet or get recently discovered in a cave. They are
constituents of a plant that has been safely consumed for tens of thousands of years. There is a
well-established process the FDA manages under current authorities for demonstrating the
safety of botanically derived dietary supplements and submitting notifications to the Agency
when a dietary supplement impacts the structure or function of the body. We consume dietary
supplements because they have an effect on the body that we could not achieve with our diet
alone.
As mentioned, we have a robust and adequate regulatory framework in place now under
DSHEA to handle all hemp extracted cannabinoids, including CBD and THC, once the Agency
properly recognizes them for what they are – well known and characterized constituents of an
old dietary ingredient (extract of cannabis) that is exempted from drug exclusion and eligible
for regulation under the current authorities in DSHEA . By taking a “drug” view of botanical
extracts and applying an extremely overbroad interpretation of drug exclusion, the Agency is
denying consumers access to safe, inexpensive, and effective alternatives to drug products. This
same Agency that should be focused on protecting the public health is instead allowing bad
actors to continue operating and proliferate the amount of dangerous products in commerce,
when they have regulations in place now to effectively control this market.
The public comments from the FDA with regards to drug exclusion and the status of
cannabidiol (CBD) as a dietary ingredient are merely statements of opinion and do not have
the force of law until there is an enforcement action against the ingredient CBD by the Agency
or a ruling by a court in an action to interpret the scope and application of drug exclusion.
The opinion of the FDA is limited to their interpretation and unfounded broad application
of the drug exclusion criteria for dietary supplements containing CBD and that interpretation has
never been adjudicated. FDA’s position that “given what we know about the safety of CBD so
far, it raises concerns for FDA about whether these existing regulatory pathways for food and
dietary supplements are appropriate for this substance,” is inappropriate by all standards. This
is a systematic and intentional misdirection to support dereliction of duty at the highest level
Our initial response is that the FDA is lying and fearmongering to misdirect the public and our
elected leaders from the truth. They have tools, and they have applied the tools before many,
many times. They have tools under the labeling rules, they have tools under the rules for
cGMP, and they have the most potent tools in their ability to review safety data in the new
dietary ingredient notification (NDIN) process and inspect manufacturers for comliance. As
stated above, I was at the FDA’s Office of Dietary Supplement Programs for over 5 years and
during my tenure at the Agency, I used those very same tools effectively on a number of
scientific, compliance, and enforcement actions. The only real issue is the drug exclusion rule
(i.e., race to market clause) and if drug exclusion were not being inappropriately applied the
FDA could review safety data in an NDIN submission and make a determination of safety for
the stated conditions of use and label on an ingredient by ingredient basis. Drug exclusion is
the false flag being presented by the FDA to justify and support their inaction and claim they
need additional authorities and millions of dollars to do their job. This is just not the case.
We spent in excess of $1MM on our safety dossier that included 5 OECD studies. Through
those studies, which align with the regulatory process established for dietary supplements and
are the highest standard of toxicology testing recognized globally,we identified levels that our
ingredient may be safely consumed. Our level is significantly lower than the dose supported by
studies for the CBD based drug Epidiolex. Milligrams per serving as opposed to several grams
per serving. Further, our conditions of use are appropriate for dietary supplements and are not
for the same conditions of use as a drug. For example, dietary supplement CBD products are
intended to support relaxation, help reduce inflammation caused by daily activities, support
health sleep patterns, and support a sense of well being. We do not, and would not ever, claim
to treat seizures due to various forms of childhood epilepsy. We have successfully
demonstrated the ingredient contained in our products is safe and our data was more than
sufficient when reviewed by regulatory agencies in other countries. cbdMD submitted a novel
food dossier to the EU and the UK. We are validated by both regulatory agencies as one of the
first naturally derived cannabinoid dossiers and we are under active review of our toxicology
data to support what is known as a Novel Food... similar to the New Dietary INgrediernt status
in the United States. Furthermore, we anticipate approval in the UK in the very near future. We
find it hard to believe that Europe has better science or unique tools to be able to analyze this
data and recognize these products for what they are... food, and more specifically, dietary
supplements. FDA should hold itself out as a leader in safety, but instead it is happy to bury its
head in the sand and lag behind other countries.
FDA recently shifted its tactics around messaging on CBD to question rodent models for
animal safety, despite the fact that they have served as appropriate preclinical safety models for
every drug and dietary supplement approved to date. In point of fact, the animal toxicology
studies underpinning the approval of Epidiolex were conducted on rodents, the same as
cbdMD’s OECD studies.
far, it raises concerns for FDA about whether these existing regulatory pathways for food and
dietary supplements are appropriate for this substance,” is inappropriate by all standards. This
is a systematic and intentional misdirection to support dereliction of duty at the highest level
Our initial response is that the FDA is lying and fearmongering to misdirect the public and our
elected leaders from the truth. They have tools, and they have applied the tools before many,
many times. They have tools under the labeling rules, they have tools under the rules for
cGMP, and they have the most potent tools in their ability to review safety data in the new
dietary ingredient notification (NDIN) process and inspect manufacturers for comliance. As
stated above, I was at the FDA’s Office of Dietary Supplement Programs for over 5 years and
during my tenure at the Agency, I used those very same tools effectively on a number of
scientific, compliance, and enforcement actions. The only real issue is the drug exclusion rule
(i.e., race to market clause) and if drug exclusion were not being inappropriately applied the
FDA could review safety data in an NDIN submission and make a determination of safety for
the stated conditions of use and label on an ingredient by ingredient basis. Drug exclusion is
the false flag being presented by the FDA to justify and support their inaction and claim they
need additional authorities and millions of dollars to do their job. This is just not the case.
We spent in excess of $1MM on our safety dossier that included 5 OECD studies. Through
those studies, which align with the regulatory process established for dietary supplements and
are the highest standard of toxicology testing recognized globally,we identified levels that our
ingredient may be safely consumed. Our level is significantly lower than the dose supported by
studies for the CBD based drug Epidiolex. Milligrams per serving as opposed to several grams
per serving. Further, our conditions of use are appropriate for dietary supplements and are not
for the same conditions of use as a drug. For example, dietary supplement CBD products are
intended to support relaxation, help reduce inflammation caused by daily activities, support
health sleep patterns, and support a sense of well being. We do not, and would not ever, claim
to treat seizures due to various forms of childhood epilepsy. We have successfully
demonstrated the ingredient contained in our products is safe and our data was more than
sufficient when reviewed by regulatory agencies in other countries. cbdMD submitted a novel
food dossier to the EU and the UK. We are validated by both regulatory agencies as one of the
first naturally derived cannabinoid dossiers and we are under active review of our toxicology
data to support what is known as a Novel Food... similar to the New Dietary INgrediernt status
in the United States. Furthermore, we anticipate approval in the UK in the very near future. We
find it hard to believe that Europe has better science or unique tools to be able to analyze this
data and recognize these products for what they are... food, and more specifically, dietary
supplements. FDA should hold itself out as a leader in safety, but instead it is happy to bury its
head in the sand and lag behind other countries.
FDA recently shifted its tactics around messaging on CBD to question rodent models for
animal safety, despite the fact that they have served as appropriate preclinical safety models for
every drug and dietary supplement approved to date. In point of fact, the animal toxicology
studies underpinning the approval of Epidiolex were conducted on rodents, the same as
cbdMD’s OECD studies.
They have also questioned their ability to regulate hemp products
using the current framework and authorities,
using the current framework and authorities,
citing the multitude of product formats that hemp products are found in as concerning.
The FDA is the federally mandated Agency
responsible for drugs, foods, and inhalable products, including several other areas. In direct
contravention to the Agency’s recent statements, cannabinoid products fit neatly into the
categories regulated by the FDA. Products that are labeled for inhalation in a non-combustible
manner are regulated by the Center for Drug Evaluation and Research (CDER). Products that
are labeled for inhalation in a combustible dose form are (or can easily be) regulated by the
Center for Tobacco Products (CTP). Products that are ophthalmic are regulated by CDER.
Products labeled for topical use are either regulated by CDER or the Center for Food Safety and
Applied Nutrition (CFSAN), where the Office of Colors and Cosmetics (OCAC) is located.
Products that are labeled for ingestion are regulated in CFSAN by the Office of Dietary
Supplement Programs (ODSP) or in the Office of Food Additive Safety (OFAS). Each of the
Centers and Offices described above has existing regulations, guidance documents, and subject
matter experts to review product submissions that contain novel botanical ingredients. Hemp
is a botanical ingredient, like t he hundreds of other botanical ingredients whose components
and constituents have been used in products labeled for inhalation, ingestion, topical use, or
others.
The laws that govern dietary supplements address combinations of ingredients, another area
FDA has included in the red herring statements about their concerns with hemp products.
Under the current framework, the manufacturer is responsible for ensuring that an ingredient
or combination of ingredients is safe for consumers before marketing a product. Unlike drugs,
dietary supplements are not allowed to cause any harm, and therefore by extension are not
permitted to contain combinations of ingredients that present harm to consumers.
Responsible, regulatorily compliant dietary supplement companies, including companies that
manufacture products containing hemp-derived cannabinoids, ensure and document for
inspection that any ingredients they use in manufacturing are safe for consumers. No dietary
supplement manufacturer should make a product that contains a combination of ingredients
that is potentially harmful and the FDA currently has the authority to inspect and verify
compliance. The laws pertaining to dietary supplements also address the other areas that FDA
has highlighted as a concern, including labeling, cGMP compliance, and warnings on
packaging. The onus is on the manufacturer to ensure that their product complies with all
applicable regulations and the FDA’s inspection and enforcement authorities under current law
allow them to ensure such compliance or remove products from the market, if only they would
do their job. The current framework has existed since 1994 and has successfully protected
consumers while allowing them to have access to non-pharmaceutical options to maintain or
improve their health. In fact, it was never the intent of the drafters of DSHEA and the drug
exclusion clasuse to prohibit an article from being both a drug and dietary supplement at the
same time. The drafters envisioned that the intended use and the labelling and marketing of
the article would determine the classification and that only in cases where the intended use of
the article was the same would drug exclusion be applied. That cannot be said about hemp
derived CBD dietary supplements.
In the absence of a federal standard, states have been forced to do the job of the federal
government and locally regulate hemp derived dietary supplements by passing legislation to
provide consumer access to hemp-derived products while ensuring that consumers are
protected from harm. In doing so, there is now a patchwork of state laws that were well-
intentioned but cause more confusion and hinder responsible manufacturers from producing
contravention to the Agency’s recent statements, cannabinoid products fit neatly into the
categories regulated by the FDA. Products that are labeled for inhalation in a non-combustible
manner are regulated by the Center for Drug Evaluation and Research (CDER). Products that
are labeled for inhalation in a combustible dose form are (or can easily be) regulated by the
Center for Tobacco Products (CTP). Products that are ophthalmic are regulated by CDER.
Products labeled for topical use are either regulated by CDER or the Center for Food Safety and
Applied Nutrition (CFSAN), where the Office of Colors and Cosmetics (OCAC) is located.
Products that are labeled for ingestion are regulated in CFSAN by the Office of Dietary
Supplement Programs (ODSP) or in the Office of Food Additive Safety (OFAS). Each of the
Centers and Offices described above has existing regulations, guidance documents, and subject
matter experts to review product submissions that contain novel botanical ingredients. Hemp
is a botanical ingredient, like t he hundreds of other botanical ingredients whose components
and constituents have been used in products labeled for inhalation, ingestion, topical use, or
others.
The laws that govern dietary supplements address combinations of ingredients, another area
FDA has included in the red herring statements about their concerns with hemp products.
Under the current framework, the manufacturer is responsible for ensuring that an ingredient
or combination of ingredients is safe for consumers before marketing a product. Unlike drugs,
dietary supplements are not allowed to cause any harm, and therefore by extension are not
permitted to contain combinations of ingredients that present harm to consumers.
Responsible, regulatorily compliant dietary supplement companies, including companies that
manufacture products containing hemp-derived cannabinoids, ensure and document for
inspection that any ingredients they use in manufacturing are safe for consumers. No dietary
supplement manufacturer should make a product that contains a combination of ingredients
that is potentially harmful and the FDA currently has the authority to inspect and verify
compliance. The laws pertaining to dietary supplements also address the other areas that FDA
has highlighted as a concern, including labeling, cGMP compliance, and warnings on
packaging. The onus is on the manufacturer to ensure that their product complies with all
applicable regulations and the FDA’s inspection and enforcement authorities under current law
allow them to ensure such compliance or remove products from the market, if only they would
do their job. The current framework has existed since 1994 and has successfully protected
consumers while allowing them to have access to non-pharmaceutical options to maintain or
improve their health. In fact, it was never the intent of the drafters of DSHEA and the drug
exclusion clasuse to prohibit an article from being both a drug and dietary supplement at the
same time. The drafters envisioned that the intended use and the labelling and marketing of
the article would determine the classification and that only in cases where the intended use of
the article was the same would drug exclusion be applied. That cannot be said about hemp
derived CBD dietary supplements.
In the absence of a federal standard, states have been forced to do the job of the federal
government and locally regulate hemp derived dietary supplements by passing legislation to
provide consumer access to hemp-derived products while ensuring that consumers are
protected from harm. In doing so, there is now a patchwork of state laws that were well-
intentioned but cause more confusion and hinder responsible manufacturers from producing
products as they must comply with a 50-state standard rather than one federal standard. State
officials and offices often do not have the requisite scientific expertise or resources to address
dietary supplement or food labeling, testing, etc.
While FDA was busy issuing statements and warning letters pertaining to egregious claims
instead of doing their job and actually regulating these products as dietary supplements, the
market shifted to products that contained designer ingredients that do not qualify as dietary
supplements and are not manufactured according to GMP standards, knowing FDA was not
going to enforce. These substances are often controlled substances, are synthetically produced,
or elicit effects that cause them to be deemed to be controlled substances. Any substance that is
scheduled under the Controlled Substances Act (CSA) should not be sold to consumers through
direct-to-consumer or retail channels. Semisynthetic derivatives or biosynthetic cannabinoids
have no place in a regulatory submission either. Those substances would not be considered
legal dietary ingredients by FDA for a regulatory submission as a food additive or a dietary
supplement. Dietary supplements must contain ingredients that are extracted from a naturally
derived, botanical source. Food additives are allowed to be semisynthetic or biosynthetic in
origin, however, the designer cannabinoids that have emerged on the market do not meet the
requirements for their intended use to be a food additive and therefore, have no place in the
current regulatory framework. FDA issued warning letters about delta-8
tetrahydrocannabidiol-containing products but has not issued a warning letter that only
addressed a product’s legal status based upon the ingredient alone (CBD).
As we discussed, states have authorizing and implementing regulations allowing the
manufacture and sale of hemp extracted orally ingestible CBD products, major retailers across
the country openly and conspicuously sell hemp extracted orally ingestible CBD products, the
Securities and Exchange commission allows the listing and trading of hemp extracted CBD
company securities, major banks and insurance companies write accounts for hemp extracted
orally ingestible products, and the courts in multiple jurisdictions have stayed or dismissed
lawsuits challenging the legal status of CBD until such time as there is a final agency action on
the ingredient or the status is adjudicated in court. All of which goes to show that the FDA is
not being truthful, and the market is moving forward without their oversight. They have tools
and they refuse to use them. We can speculate on the reasons behind their position, but it is
clear they are simply abdicating their duties to protect the public health and instead choosing
to deny consumers access to safe and efficacious products. We are deeply disappointed that
FDA has chosen to make excuses for their dereliction, rather than use their tools and find a
reasonable solution.
The FDA has spent more time plotting their public relations campaign to malign hemp
extracted cannabinoid ingredients than they have spent addressing any public health matter
and reasonably regulating these ingredients. The real issue is about the role of natural products
and pharmaceutical IP in the marketplace and the FDAs historical refusal to properly recognize
natural products in that ecosystem. This is most clearly manifested in the issue presented
before you of the FDAs failures and inaction when it comes to properly regulating botanically
derived, orally ingested, hemp extracted cannabinoids as dietary supplements. DSHEA was
never intended to exclude these natural products, even when an approved drug exists, except in
the rare cases where the drug and the dietary supplement are effectively the same thing,
meaning the same dose marketed for the same purpose.
dietary supplement or food labeling, testing, etc.
While FDA was busy issuing statements and warning letters pertaining to egregious claims
instead of doing their job and actually regulating these products as dietary supplements, the
market shifted to products that contained designer ingredients that do not qualify as dietary
supplements and are not manufactured according to GMP standards, knowing FDA was not
going to enforce. These substances are often controlled substances, are synthetically produced,
or elicit effects that cause them to be deemed to be controlled substances. Any substance that is
scheduled under the Controlled Substances Act (CSA) should not be sold to consumers through
direct-to-consumer or retail channels. Semisynthetic derivatives or biosynthetic cannabinoids
have no place in a regulatory submission either. Those substances would not be considered
legal dietary ingredients by FDA for a regulatory submission as a food additive or a dietary
supplement. Dietary supplements must contain ingredients that are extracted from a naturally
derived, botanical source. Food additives are allowed to be semisynthetic or biosynthetic in
origin, however, the designer cannabinoids that have emerged on the market do not meet the
requirements for their intended use to be a food additive and therefore, have no place in the
current regulatory framework. FDA issued warning letters about delta-8
tetrahydrocannabidiol-containing products but has not issued a warning letter that only
addressed a product’s legal status based upon the ingredient alone (CBD).
As we discussed, states have authorizing and implementing regulations allowing the
manufacture and sale of hemp extracted orally ingestible CBD products, major retailers across
the country openly and conspicuously sell hemp extracted orally ingestible CBD products, the
Securities and Exchange commission allows the listing and trading of hemp extracted CBD
company securities, major banks and insurance companies write accounts for hemp extracted
orally ingestible products, and the courts in multiple jurisdictions have stayed or dismissed
lawsuits challenging the legal status of CBD until such time as there is a final agency action on
the ingredient or the status is adjudicated in court. All of which goes to show that the FDA is
not being truthful, and the market is moving forward without their oversight. They have tools
and they refuse to use them. We can speculate on the reasons behind their position, but it is
clear they are simply abdicating their duties to protect the public health and instead choosing
to deny consumers access to safe and efficacious products. We are deeply disappointed that
FDA has chosen to make excuses for their dereliction, rather than use their tools and find a
reasonable solution.
The FDA has spent more time plotting their public relations campaign to malign hemp
extracted cannabinoid ingredients than they have spent addressing any public health matter
and reasonably regulating these ingredients. The real issue is about the role of natural products
and pharmaceutical IP in the marketplace and the FDAs historical refusal to properly recognize
natural products in that ecosystem. This is most clearly manifested in the issue presented
before you of the FDAs failures and inaction when it comes to properly regulating botanically
derived, orally ingested, hemp extracted cannabinoids as dietary supplements. DSHEA was
never intended to exclude these natural products, even when an approved drug exists, except in
the rare cases where the drug and the dietary supplement are effectively the same thing,
meaning the same dose marketed for the same purpose.
Congresses intent from the start was clear, that articles could exist at the same time as both
a drug and dietary supplement, and that
such article could continue to exist as a dietary supplement so long as it is properly labelled
and marketed.
It is our position at cbdMD, based on a reasonable interpretation of applicable federal law, that
our products are fully compliant and legal dietary supplements under the Food Drug and
Cosmetic Act, as amended by the Dietary Supplement Health and Education Act. We
maintain compliance the same as all responsible dietary supplement brands by addressing the
four corners of the Act: GMP, Labelling/Claims, Adverse Event Reporting, and Ingredient
Safety. We would welcome an audit and inspection by the FDA, as any responsible dietary
supplement manufacturer would. We have a fully documented safety dossier and have
completed multiple double blind, placebo controlled clinical studies to demonstrate the efficacy
of our products. We have sold millions of servings to hundreds of thousands of consumers
without any adverse events. Our products have been consumed by Olympic athletes, UFC
champions, top professional golfers, motorsports champions, and athletes in the NFL, NHL,
NBA and MLS just to name a few. First responders rely on our products to help them with
maintain health and wellness. cbdMD has earned customer trust and established ourselves as
leaders in the industry. We will not stand idely by while the FDA uses fearmongering to smear
our brand and industry and remove a consumer’s choice to use our products to maintain and
improve their health and wellness. We are considering all of our options to ensure that our
customers are not denied access to safe, efficacious dietary supplements and we hope that this
oversight hearing can shed light into why the FDA has failed in their statutory obligations and
possibly bring a reasonable conclusion to this farce without the need to seek redress in the
courts.
We have included questions below, which we believe FDA should respond to on the record:
1. The FDA has received an ongoing appropriation for research on CBD. What research
have they done to date and when will those results be made public?
a. Are the testing levels consistent with general use by the public in food, or are they
only replicating the extremely high levels more appropriate for drug studies?
b. Were they designed according to current toxicological principles?
c. What were the dose ranges used?
d. Were they designed to derive a “no observed adverse effect level” (NOAEL)?
e. If the Agency has initiated and/or completed tests in which species, were they
performed?
2. What is the biological and chemical basis for determining that hemp products are so
drastically different from other botanical ingredients that they are not able to be
regulated by the framework that has functioned appropriately for all other botanical
ingredients?
3. Why has the FDA taken such a unique stand in CBD, when another cannabinoid CBN,
with a similar safety profile, has been allowed to be sold as a dietary supplement?
a. Are other cannabinoids viewed as being drug precluded or are they allowed to
proceed through a food additive or NDIN path?
and marketed.
It is our position at cbdMD, based on a reasonable interpretation of applicable federal law, that
our products are fully compliant and legal dietary supplements under the Food Drug and
Cosmetic Act, as amended by the Dietary Supplement Health and Education Act. We
maintain compliance the same as all responsible dietary supplement brands by addressing the
four corners of the Act: GMP, Labelling/Claims, Adverse Event Reporting, and Ingredient
Safety. We would welcome an audit and inspection by the FDA, as any responsible dietary
supplement manufacturer would. We have a fully documented safety dossier and have
completed multiple double blind, placebo controlled clinical studies to demonstrate the efficacy
of our products. We have sold millions of servings to hundreds of thousands of consumers
without any adverse events. Our products have been consumed by Olympic athletes, UFC
champions, top professional golfers, motorsports champions, and athletes in the NFL, NHL,
NBA and MLS just to name a few. First responders rely on our products to help them with
maintain health and wellness. cbdMD has earned customer trust and established ourselves as
leaders in the industry. We will not stand idely by while the FDA uses fearmongering to smear
our brand and industry and remove a consumer’s choice to use our products to maintain and
improve their health and wellness. We are considering all of our options to ensure that our
customers are not denied access to safe, efficacious dietary supplements and we hope that this
oversight hearing can shed light into why the FDA has failed in their statutory obligations and
possibly bring a reasonable conclusion to this farce without the need to seek redress in the
courts.
We have included questions below, which we believe FDA should respond to on the record:
1. The FDA has received an ongoing appropriation for research on CBD. What research
have they done to date and when will those results be made public?
a. Are the testing levels consistent with general use by the public in food, or are they
only replicating the extremely high levels more appropriate for drug studies?
b. Were they designed according to current toxicological principles?
c. What were the dose ranges used?
d. Were they designed to derive a “no observed adverse effect level” (NOAEL)?
e. If the Agency has initiated and/or completed tests in which species, were they
performed?
2. What is the biological and chemical basis for determining that hemp products are so
drastically different from other botanical ingredients that they are not able to be
regulated by the framework that has functioned appropriately for all other botanical
ingredients?
3. Why has the FDA taken such a unique stand in CBD, when another cannabinoid CBN,
with a similar safety profile, has been allowed to be sold as a dietary supplement?
a. Are other cannabinoids viewed as being drug precluded or are they allowed to
proceed through a food additive or NDIN path?
4. What adverse events have been reported to FDA that are associated with CBD dietary
supplements and foods, excluding products labeled or marketed as delta-8 THC or
related compounds including delta-10 THC, HHC, THC-O, and THC-P?
a. Have adverse events been reported for products containing the designer
compounds listed above?
b. What is FDA’s plan to enforce against products with designer compounds if they
have adverse events attributed to those products?
5. If FDA has concerns with rodent models for hemp safety studies, has FDA considered
this impact on preclinical pharmaceutical safety studies?
a. Has FDA considered a framework supporting the submission of in silico or in
vitro studies in lieu of animal safety studies?
6. Explain in detail the Agencies understanding and interpretation of the drug exclusion
rule as applied to a botanically derived article intended to be sold as a dietary
supplement which does not purport to serve the same function as an approved drug,
which is presented in significantly smaller servings, and which is not marketed for the
prevention, treatment, or cure of the same indication as the approved drug.
Thank you for this hearing and for the opportunity to submit this statement today.
Sibyl Swift, Ph.D.
Chief Science Officer & VP Regulatory Affairs
cbdMD, Inc.
8845 Red Oak Blvd
Charlotte, NC 28217
sibyl.swift@cbdmd.com
Mobile: 301-586-5482
related compounds including delta-10 THC, HHC, THC-O, and THC-P?
a. Have adverse events been reported for products containing the designer
compounds listed above?
b. What is FDA’s plan to enforce against products with designer compounds if they
have adverse events attributed to those products?
5. If FDA has concerns with rodent models for hemp safety studies, has FDA considered
this impact on preclinical pharmaceutical safety studies?
a. Has FDA considered a framework supporting the submission of in silico or in
vitro studies in lieu of animal safety studies?
6. Explain in detail the Agencies understanding and interpretation of the drug exclusion
rule as applied to a botanically derived article intended to be sold as a dietary
supplement which does not purport to serve the same function as an approved drug,
which is presented in significantly smaller servings, and which is not marketed for the
prevention, treatment, or cure of the same indication as the approved drug.
Thank you for this hearing and for the opportunity to submit this statement today.
Sibyl Swift, Ph.D.
Chief Science Officer & VP Regulatory Affairs
cbdMD, Inc.
8845 Red Oak Blvd
Charlotte, NC 28217
sibyl.swift@cbdmd.com
Mobile: 301-586-5482