CBDMD Response to Congressional Request for Information Page1

 

 

 

August 17, 2023

 

Re:  Response to Bicameral Request for Information Regarding Food and Drug Administration (FDA) Regulation of Hemp-Derived Cannabidiol

 

Committee Members and Staff:

 

cbdMD appreciates the opportunity to provide Congress with crucial information to inform its efforts to provide a regulatory pathway through legislation for hemp derived products. We are respectfully submitting a response today to ensure Congress receives the requisite information from a top hemp brand that has taken the necessary steps to be fully compliant with the Food, Drug and Cosmetic Act (FD&C Act).

 

We know the FDA has the tools to regulate hemp derived products using the existing regulatory framework and have clearly pointed this out throughout our response. The hemp industry, including farmers, processors, manufacturers, and retailers, will continue to languish without regulatory clarity. Consumers’ freedom to choose how to best manage their health and wellness is also significantly impacted. We are not asking for special treatment; we are asking to be treated like every other dietary ingredient or cosmetic and apply the regulations within the FD&C Act to our industry. The American people deserve access to naturally derived products for everyday health and wellness.

 

We would be happy to provide Committee Members with additional information as they consider next steps.

 

Regards,

 

Sibyl Swift, Ph.D. and Lance M. Blundell, Esq. 

 

United States Congress Request for Information Regarding the Regulation of Cannabidiol Products: cbdMD Response

 

Current Market Dynamics

 

1.    What does the current market for CBD products look like? Please describe the types and forms of products available, manufacturing practices within the industry, market supply chain, how products are marketed and sold, the types of cannabinoids used in products, the marketed effects of CBD products, and the range of CBD doses currently found in the market.

 

Types and Forms of Products Available:

 

Hemp Extract/CBD Products are available in the following forms:

 

• Dietary Supplements and Foods/Beverages. The Dietary Supplements consist of many orally ingestible form factors including tinctures, gummies, capsules, softgels, pressed tablet pills, oral dissolvable strips, powdered drink mixes, single serving RTD shots, and aerosol mist. The Foods/Beverages consist of infused or enhanced traditional foods and beverages.
• Cosmetics/OTC: Topicals (e.g., lotion or roll ons) with hemp derived cannabinoids as cosmetic ingredients or as inactive ingredients in an OTC monograph product such as a topical analgesic.
• Inhalable: vapes or combustible plant matter
• Pet Products: Hard/Soft Chews, Tinctures, Topicals

 

Manufacturing Practices: Manufacturing depends on the product type and responsible manufacturers currently comply with all applicable regulations for the product category type under Food, Drug and Cosmetic Act (FDCA).

 

• Dietary Supplements/Foods: Products marketed as dietary supplements or conventional foods should comply with 21 CFR Part 117 for foods and 21 CFR Part 111 for dietary supplements, as well as applicable Food Safety Modernization Act (FSMA) requirements and other regulations applicable to Foods/Dietary Supplements.

 

• Cosmetics/OTC: Following the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), companies manufacturing Cosmetics with hemp derived cannabinoids, such as CBD, must adhere to the FDA’s cGMP framework for cosmetics. For combination OTC products that contain CBD as an inactive or cosmetic ingredient, it is expected that manufacturers adhere to federal cGMPs applicable to OTC drug products.

 

• Pet Products: All Pet Products fall into a regulatory gray area, including traditional non-hemp derived pet products, as there is no specific category under the FDCA for pet supplements or topicals.  Responsible  manufacturers  will  manufacture  to  the  standards  applicable  for Foods/Dietary Supplements or Topicals/OTC. 

Market Supply Chain: Responsible manufacturers and brand owners of Hemp Derived Products source their hemp raw materials from US suppliers. There are foreign suppliers of hemp biomass and hemp extracted cannabinoids and the lack of regulatory oversight by the FDA allows for substandard materials to enter the supply chain without proper verification of cGMP and other required regulatory standards. Raw  materials  include  hemp  biomass  for  extractors  and  hemp  extracted  cannabinoids  for formulators/manufacturers. Hemp biomass containing less than 0.3% THC is currently grown in most states and immediately after passage of the 2018 Farm Bill was a very profitable crop for US farmers. The price of hemp biomass, and its downstream hemp extracted cannabinoids, have dropped precipitously. Stalled growth of the market due to the regulatory uncertainty created through the FDAs inaction and misinformation campaign has led to an oversupply of hemp biomass and crude oil, driving prices down and negatively impacted hemp farmers. Many of those impacted are minority farmers who had turned to hemp as a lifeline to save their livelihood when other crops like tobacco had experienced a significant decline in demand.

 

Methods of Sale: Hemp Derived Products are sold through all channels in the United States, including traditional brick and mortar retail and through direct to consumer channels such as the internet or direct sales organizations. Notably, large national and regional chains have been hesitant to offer CBD products for sale and companies like Amazon, Target, Walmart and Costco are staying on the sidelines awaiting regulatory clarity.

 

Types of Cannabinoids Used in Products: There are three types of Hemp Derived Products on the market generally defined as Isolate (single cannabinoid), Broad Spectrum (two or more cannabinoids plus terpenes with no THC), and Full Spectrum (two or more cannabinoids, one of which is THC, plus terpenes). The naturally occurring cannabinoids found in each category of product at this time are CBD (Cannbidiol),  CBG  (Cannabigerol),  CBC  (Cannabichromine),  CBN  (Cannabinol),  CBDV (Cannabidivarin), THCV (Tetrahydrocannabivarin), D9 THC (Delta 9 Tetrahydrocannabinol), D8 THC (Delta 8 Tetrahydrocannabinol), and the acid versions of several of the cannabinoids such as CBDA (Cannabidiolic  Acid),  CBGA  (Cannabigerolic  Acid)  and  THCA  (Tetrahydrocannabinolic Acid). Currently most testing laboratories can test for 16 Cannabinoids in the standard testing and 22+ cannabinoids with expanded testing. The majority of the cannabinoids other than CBD, CBG, CBC, CBN and THC are found in such small amounts that they are not used in isolate products and are only found in trace amounts in Broad Spectrum or Full Spectrum products.

 

Marketed Effects of Cannabinoid Products: Under DSHEA, the approved claims for Dietary Supplements are limited to structure/functions claims. Responsible brands do not make claims related to treating, curing, or preventing disease. Cannabinoids work on the Endocannabinoid System which generally regulates homeostasis. Proper claims for Dietary Supplement products include without limitation: general health and wellness, relaxation, healthy sleep, reduction in temporary/occasional pain from activity, reduction in activity induced inflammation, regulation of mood, and improved focus/mental clarity. Topical Products can help with moisture and improve skin condition. Combination Cosmetic/OTC products are limited to the claims specific to the OTC Monograph ingredient such as Topical Analgesic claims related to temporary relief from minor pain. Pet Products make similar claims as specifically related to pets. It should be noted here that the lack of regulatory clarity and refusal to use current authorities by the FDA is a disincentive for industry to conduct the research necessary to support structure/function claims. A decision to remove Drug Exclusion or legislation directing the FDA to treat Hemp Extracted Products under current authorities in the FDCA would spur investments by responsible companies into the research necessary to support structure/function claims and allow the FDA to review such claims and enforce against companies who do not conduct the requisite research to support claims.

 

Range of CBD Doses Found in the Market: Products containing CBD range from 25 mg per serving up to 250 mg per serving. Responsible manufacturers and brand owners will have already conducted the statutorily required safety studies to submit an New Dietary Ingredient Notification (NDIN) or maintain a Self Affirmed GRAS, as is required under the existing regulations for Foods/Dietary Supplements. The FDA’s current mis-application of Drug Exclusion under the Dietary Supplement Health and Education Act (DSHEA) is what precludes these responsible manufacturers and brand owners from submitting this safety data to the FDA as it will be summarily rejected.

 

1. How has the market changed since the passage of the 2018 Farm Bill?

 

The day the 2018 Farm Bill became effective, the Food and Drug Administration (“FDA”) released its opinion that despite the Farm Bill passing, it was still illegal to market CBD as a dietary supplement or to use CBD as a food additive based on CBD being Drug Excluded due to the prescription drug Epidiolex.

 

This opinion is flawed and unsupported as it does not account for the fact that Extract of Cannabis (a Full Spectrum Tincture product) is an old dietary ingredient as it was legally marketed in the United States from the mid 1800s thru the time when Cannabis prohibition began, and is clearly documented as such in the published United States Pharmacopeia (USP) during the relevant time periods. Time, and the fact it was prohibited and scheduled as a controlled substance, has hidden this from the public domain. Despite Extract of Cannabis, and by extension extract of hemp, being an old dietary ingredient and not subject to Drug Exclusion, the looming specter of potential impending regulatory action by FDA and a constant flow of misleading information has persisted since the 2018 Farm Bill, suffocating the market and stifling growth.

 

The FDA’s continued comments in combination with its unwillingness to act have caused big box stores, large retail chains, and major food and beverage brands to reject the sale of products containing CBD and other hemp extracts. Stalled growth of the market has led to an oversupply of hemp biomass and crude oil, driving prices down and negatively impacted hemp farmers. Many of those impacted were minority farmers who had turned to hemp as a lifeline to save their livelihood when other crops like tobacco had experienced a significant decline in demand.

 

1. How is the lack of national standards for CBD products affecting the market?

 

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 multiple, varied state standards rather than one federal standard. Making matters worse, state officials and offices do not have the requisite scientific expertise or resources to address dietary supplement/food/cosmetic labeling, testing, cGMP, claim review, etc., and are not able to adequately inspect or enforce across state lines.

 

Lack of national standards has also led to the proliferation of unregulated products, many of which raise significant quality, safety, and other consumer protection concerns that would not exist if the FDA utilized their current authorities to regulate the products as Dietary Supplements/Foods/Cosmetics. Adding to these issues, surplus hemp derived CBD isolates are being chemically converted into impairing products, such as chemically derived Delta-8 THC (not to be confused with the small amounts of Delta-8 THC found in the hemp plant and which may be present in trace amounts in Broad/Full Spectrum Hemp Derived Products), which are being sold unregulated, sometimes to minors.

 

Any naturally occuring cannabinoid found in the hemp plant should be available to develop into safe and efficacious products under the current regulatory regime for Dietary Supplements/Foods/Cosmetics, following all guidelines. However, they need to be strictly regulated for safety, kept out of the hands of children, and similar to allowable food products containing trace amounts of alcohol such as Kombucha, products containing cannabinoids such as THC in amounts that could cause impairment could be regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). This is discussed in more detail below.

 

Under current authorities found in the FDCA, semisynthetic derivatives or biosynthetic cannabinoids would have no place in a regulatory submission for a Dietary Supplement or Food and would therefore be precluded from the market. 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 (such as hemp). 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.

 

Pathway

 

4.    Please comment on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.

 

Our initial response is that the FDA is misrepresenting facts and intentionally misleading the public and our elected leaders from the truth.

 

The FDA has data and has been offered additional data to support the safety of low dose Dietary Supplement/Food/Cosmetic products in the milligram strengths found in the market. Further, the current authorities require companies to validate the safety of their products and either submit that information in an NDIN or publish that information in a peer reviewed journal in order to validate a Self Affirmed GRAS status and the FDA could enforce against those without the requisite safety data, as has been within their authority since DSHEA was implemented in 1994. Their reference to data from studies that fed animals drug level doses without any intent to find a safe “No Observed Adverse Event Level” (NOAEL), or the use of animals predisposed to issues that skew the data to serve the (unstated) goal of NOT finding a safe level, is disingenuous at best and fraudulent at worst.

 

The FDA has tools, and they have applied the tools before many, many times since the enactment of DSHEA in 1994. 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 or review the peer reviewed publication of safety data required for a Self Affirmed GRAS, and inspect manufacturers for compliance.

 

Our company is keenly aware of the abilities the FDA actually has under their current authorities, regardless of if they actually use them properly or falsely claim they do not exist at all. We know this because Dr. Sibyl Swift is the Chief Science Officer for cbdMD, the company submitting this response to the RFI, and she was at the FDA’s Office of Dietary Supplement Programs for over 5 years. During her tenure at the Agency, she effectively used those very same tools on a number of scientific, compliance, and enforcement actions. We speak from experience and application of those self same rules the FDA claims are inadequate.

 

The only real issue is the drug exclusion rule (i.e., race to market clause). If drug exclusion were not being inappropriately applied, the FDA could review safety data in an NDIN submission or companies could publish their safety data in peer reviewed journals, and the FDA could make a reasoned determination of safety for the stated conditions of use and label on an ingredient by ingredient basis. This is their mandate under FDCA and has been their obligation under DSHEA for nearly 30 years, with a robust tool set available to them to regulate the market, regardless of any statements to the contrary. 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.

 

The FDA is the federally mandated Agency responsible for drugs, foods, and inhalable products, including several other areas. They have existing authorities to regulate these product categories and in direct contravention to the Agency’s recent statements, the Hemp Derived Products at issue all 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 the hundreds of other botanical ingredients whose components and constituents have been used in products labeled for inhalation, ingestion, topical use, or others. If the Agency needs subject matter experts specifically for Cannabis/Hemp, the proper solution is to place those experts within the existing infrastructure, in the appropriate currently existing center. The solution is not to recreate the wheel for a single plant. When it comes to combinations of ingredients in a single product, the current laws that govern Dietary Supplements address combinations of ingredients, another area FDA has included in the red herring statements about their concerns with Hemp Derived 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 all 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, warnings on packaging, claims substantiation, and adverse event tracking and reporting. 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 clause 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 labeling 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/Foods/Cosmetics.

 

Scope

 

1. How should CBD and/or cannabinoid-containing hemp products be defined? What compounds should be included and excluded from a regulatory framework?

 

We believe ingestible and topical hemp cannabinoid products can be effectively regulated under existing frameworks for food, dietary supplements, or cosmetics. Drug products, as defined in the FD&C Act, and inhalable/combustible products are obviously not considered food, dietary supplements, or cosmetics and should remain outside the scope of these regulatory frameworks, but drug products have a place within the current framework for drugs and inhalable/combustible products could easily be placed within CTP and therefore all options can be covered by existing authorities. AS stated above, if subject matter expertise is needed for cannabis products, the subject matter expert can be hired into the applicable existing Center and avoid the needless time and expense of recreating each specialty within a new center.

 

1. Should Congress or FDA limit the amount of intoxicating or potentially intoxicating substances produced by Cannabis sativa L. in food and dietary supplements? Which substances, if any, warrant greater concern? How should these substances of concern be addressed? What products, if any, should not be allowed on the market?

 

Congressional or Federal Limitation of the Amount of Intoxicating Substances in Food and Dietary Supplements: The clear answer is yes, potentially intoxicating cannabinoids should be limited in the food supply. As has been stated repeatedly herein, the FDA’s failure to regulate Hemp Derived Products under current authorities has created a disincentive for companies to invest in what would be statutorily required studies to determine things like safety, efficacy for claims, and threshold levels of potentially impairing substances in order to be compliant with the existing statutory requirements..

 

There is precedent for this with alcohol and how it is regulated in the food supply as an adulterant if it is above a threshold level. This level should be determined by companies as part of their safety submissions based on the indications for use, instructions and warnings related to the products. FDA could set a reasonable level based on science by studying the threshold of impairment when healthy adults orally consume potentially impairing cannabinoids.

 

There is an existing regulatory framework for products which may cause impairment. The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates products that fall into an adult-only framework when those products may cause impairment, like alcohol. Products with small amounts of alcohol, like kombucha, containing less than a 0.5% ABV limit are considered food. FDA would regulate Hemp Derived Products which are below a threshold level of impairment, while those that may be impairing would fall under the jurisdiction of TTB. TTB has the requisite expertise and experience regulating products intended for adult use, such as tobacco or alcohol and should be directed to regulate ingestible products containing impairing cannabinoids. Further, those products should be taxed similar to alcohol and tobacco, which falls under the authority of TTB and not FDA. Topical Products containing CBD and other hemp-derived cannabinoids do not require a new framework and should continue to be regulated under the current comprehensive framework for cosmetics.

 

The reality is, if products that are potentially impairing were to be banned rather than regulated, they would continue to persist in illicit markets with poor manufacturing, posing harm to consumers.

 

b.   How should Congress or FDA identify appropriate limits for THC and other cannabinoids in finished products? Relatedly, how should a framework account for “total THC,” including tetrahydrocannabinol acid (THCA), in FDA’s regulation of intermediate and finished products?

 

Relatively simple and inexpensive human clinical studies could be conducted and completed in a short amount of time to determine threshold impairment levels of specific cannabinoids when ingested orally. These tests currently exist for alcohol impairment and have been used to successfully determine threshold consumption levels of alcohol that lead to impairment and public safety risks associated with automobile use. There is no reason to establish a different paradigm for cannabinoids.

 

Several leading industry scientists have worked with the US Hemp Roundtable to develop a white paper using peer-reviewed publications to identify a level of THC in finished products that we believe will not lead to impairment in most consumers. That paper will be submitted to members of Congress as part of the RFI process. In that paper, it was determined that 5 milligrams of THC per serving in ingestible products, when presented with adequate instructions for use and warnings, can serve as a reasonable threshold. Any products falling below that limit would be in FDA’s jurisdiction; products above 5 milligrams of THC per serving would fall under TTB’s jurisdiction.

 

Ultimately, Congress and/or FDA should set levels for impairment using scientific studies. In the absence of federal regulation, states have set varying levels that do not appear to be based upon manufacturing or science, but rather by constituents with the loudest voices. This is not sound and causes confusion in the marketplace and disincentives for companies to do real science to establish actual threshold levels.

 

c.   Should FDA regulate the manufacture and sale of “semisynthetic derivatives,” or “biosynthetic cannabinoids,” which are still scheduled under the CSA?

 

Purely synthetic cannabinoids that have no origin from the cannabis plant have no place in ingestible products under FDA’s jurisdiction. There is no path for a synthetic ingredient in dietary supplements, outside of specific exceptions for vitamins. There is no path for a synthetic ingredient through the Generally Recognized as Safe pathway either, as synthetic cannabinoids are mostly intended to impair, which is federally illegal for an ingredient in food.

 

The term “semisynthetic derivatives” should be clearly defined under a federal definition and regulation. FDA should regulate non-scheduled, semi-synthetic derivatives under the existing framework with mandatory cGMPs, labeling requirements, and safety evaluations required as appropriate. Impairing products, including semi-synthetic derivatives, would be regulated by an agency such as TTB and reserved for adult use only.

 

6.   Other non-cannabinoid products are available on the market that have raised safety concerns among some individuals, which FDA has regulated without a substance-specific regulatory framework (e.g. kratom, caffeine, etc.). How has FDA dealt with products containing those substances? How might these products be implicated by a CBD-specific product framework?

 

We are acutely aware of the challenges posed by substances such as highway concentrated, pure powdered caffeine, including the potential challenges faced by FDA in regulating these substances. In fact, Dr. Swift was a key participant in analyzing and drafting the FDAs guidance document on highly concentrated caffeine. We can therefore state with absolute certainty that the FDA has the ability to analyze and guide on the use of ingredients of concern without creating new centers or banning entire categories completely. The FDA, under current authorities, has the ability to study and draft guidance and reasonable required warnings related to products which are allowed to stay on the market subject to responsible companies following the guidance or being subject to inspection and enforcement. This has been done time and time again with great success in protecting public health while at the same time allowing products with demonstrated benefits to remain on the market.

 

With that experience in mind, and based on the safety data available to date, including our own company’s extensive toxicity study portfolio, we do not believe CBD or the many other hemp-derived cannabinoids, when manufactured under cGMP and labeled appropriately, pose the same challenges or health risks and therefore should not be regulated in the same manner. We believe the existing frameworks for Dietary Supplements/Foods/Cosmetics  provide  adequate  safeguards  for  non-impairing  hemp-derived cannabinoids.

 

1. How has the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others?

 

Lack of national standards has led to the proliferation of unregulated products, and an inability or lack of desire to enforce and remove such products from the market, some of which raise significant quality, safety, and other consumer protection concerns.

 

1. What is the public health impact of these novel compounds?

 

Potentially impairing compounds like Delta-8 THC, Delta-10 THC, THC-O, and HHC, which are most commonly produced by chemically converting hemp-derived CBD extracts, outside of some state-based regulations, are being sold unregulated at retail. Some of these products pose public health impacts because of their high concentrations of THC, their manner of being marketed in ways that are appealing to children, and the lack of manufacturing controls that leave dangerous solvents and pesticides in products. Many of these products do not even contain the impairing cannabinoids listed on the labels, they contain other even more potentially harmful unregulated substances, as the companies have no concern for being audited or inspected by the FDA.

 

1. How have FDA and state regulators enforced against products containing these compounds?

 

Apart from the “5 Things to Know” consumer update issued by FDA about Delta-8 THC and Warning Letters issued to manufacturers and distributors of Delta-8 THC products, we are not aware of any regulation of Delta-8 THC or enforcement against such products by FDA. We are not aware that FDA has issued Warning Letters, public statements, or taken other action against similar impairing products such as Delta-10 THC, HHC, THC-O, etc.

 

On the other hand, some states have chosen to regulate impairing products like Delta-8 THC on their own. Their regulations vary and range from legalization to restriction to adult-use markets, to complete prohibition. States that have chosen to regulate impairing products have seized products and shut down operations for those companies they deemed to be in violation of their regulations.

 

1. How should Congress consider the inclusion of these products in a regulatory framework for cannabinoid hemp products, if at all?

 

As discussed extensively herein, we propose using the existing framework whereby FDA sets a threshold level for per-se impairment from orally consuming certain potentially impairing cannabinoids and then regulates the non-impairing hemp products and TTB regulates products that may be impairing in an adult-only framework. By utilizing existing frameworks and setting reasonable threshold limits above which a product would be considered adulterated, the FDA could quickly and easily take control of the market for impairing cannabinoids by reviewing labels and product certificates of analysis, by obtaining products from the market and having them tested, and aggressively enforcing against bad actors. In addition, state attorneys general and private citizens under consumer protection laws would provide a significant disincentive to companies putting adulterated products on the market through threat of legal action.

 

1. CBD products are not limited to just ingestible routes of administration—some are interested in products with alternative routes of administration (e.g., inhalable, topical, ophthalmic drops, etc.).

 

1. For which non-ingestible routes of administration are consumers interested in consuming CBD products?

 

Consumers have expressed interest in non-ingestible inhalable, topical, ophthalmic drops, and injectable products. Each of which already has a place to be regulated under current frameworks and authorities.

 

1. How should a regulatory framework for cannabinoid products account for non- ingestible routes of administration?

 

Existing authorities, such as those in place for drugs, alcohol, tobacco and cosmetics are the appropriate means for non-ingestible products to be regulated. Cosmetics will be regulated by FDA through the Modernization of Cosmetics Regulation Act (MoCRA), and issues such as THC and CBD limits and child-proof packaging that plague ingestible products are not an issue for non- ingestible products.

 

We support a regulatory framework for inhalable products and believe this can be done through the Center for Tobacco Products (CTP). It is important, however, that ingredients used in inhalable products be considered separately from those used in ingestible products. They differ significantly in terms of how the body metabolizes them and the potential adulterants, among other things. In addition, different categories of inhalable products require different considerations and tolerances, separate and apart from food, dietary supplements, or cosmetics. Proper subject matter experts should be placed in each Center in order to properly address the issues using existing frameworks and authorities.

 

Federal-State Interaction

 

1. In the absence of federal regulation or enforcement over CBD products, many states have established state regulatory programs to safeguard public health and create market certainty for industry participants.

 

1. Which  product  standards  relating  to  warning  labels,  minimum  age  of  sale, manufacturing and testing, ingredient prohibitions, adverse event reporting, and others, have states adopted to protect consumer safety?

 

States have enacted various requirements for hemp cannabinoid products, including manufacturing and testing standards, threshold pollutant levels, registration and product listing, product approval, age limits, adverse event reporting, cannabinoid and THC limits per serving and per package, ingredient prohibitions, warning labels, child-proof and tamper-evident packaging, and storage restrictions. The various requirements exist in a non-uniform patchwork of regulations. 

 

b.   Which such standards, if any, should Congress look to as models?

 

Congress should look to all state standards and mandate the FDA take a “best in class” approach to what should be reasonably required. Product testing and establishing maximum pollutant/adulterant levels in Dietary Supplements/Foods/Cosmetics is already something the FDA requires under various provisions of the FDCA. Many of the state mandated requirements such as those for labeling would be handled as a matter of course under the FDCA and the requirements to provide adequate instructions for use and warnings. Hemp-derived cannabinoids do not require a new facts panel, as they can be listed like any other botanically derived Dietary Supplement/Food/Cosmetic. Reasonable consumer information requirements that are reasonably related to the existing authorities would be welcomed by industry to provide a level playing field and provide a national standard by which all companies could be held accountable.

 

10. How should Congress consider federal preemption as it works towards a regulatory pathway? Should states be able to continue to build upon federal regulation of CBD products?

 

Given the disruptive and conflicting patchwork of state laws that have emerged in recent years due FDA inaction, the new federal law should preempt state laws, particularly when it comes to labeling, packaging, and the criminal prohibition of certain hemp products. We oppose legislation that sets a “federal floor” of standards, allowing states to be more prescriptive, particularly as it relates to cGMPs, testing, packaging, and labeling. The current patchwork of state requirements has left both consumers and industry confused, and therefore preemption is necessary to establish comprehensive, uniform requirements that help ensure consumer health, safety, and transparency in labeling.

Safety

 

11. What is currently known about the safety and risk-benefit profile of CBD and other hemp derived cannabinoids? What safety and toxicity data are available to support this knowledge. Please include in your answer any relevant information about safety with regard to specific populations, such as children and pregnant individuals.

 

Current Safety Knowledge: Publicly available toxicity studies from around the globe covering a range of CBD-containing ingredients, combined with the safety data in humans reflected in clinical trials, and observational studies, provide ample evidence that CBD can be safely consumed at the serving sizes found in most CBD dietary supplements and foods sold at retail, i.e., lower milligram dosage CBD products not intended for use as drugs, and regulated under the existing regulatory frameworks for dietary supplements and food.

 

Available Safety and Toxicity Data: There is a growing body of scientific evidence demonstrating the safety of orally consumed CBD at milligram amounts commensurate with a dietary supplement level, such as the amounts typically found in CBD food and dietary supplement products sold at retail. There are multiple toxicity studies published between 2020 and 2023 demonstrating the safety of CBD at these lower amounts, as well as other studies we expect to be published soon. Our study focused on male and female reproductive toxicity, however, the majority of the studies published to date were designed to establish safe intake levels of CBD for healthy adults who are not pregnant or nursing. Additional studies are required to establish safe consumption levels of CBD as a dietary supplement or food for vulnerable populations such as children and pregnant individuals, but clear warning labels can be used until such time as those studies are conducted.

 

Notably, international regulatory bodies have reviewed the same publicly available evidence and determined that CBD products can be safely marketed to healthy adults who are not pregnant or lactating. The World Health Organization determined that pure CBD is “generally well tolerated with a good safety profile” and presents little risk of abuse or dependence potential, recreational use, or public health-related problems.[1] Australia’s Therapeutic Goods Administration concluded that CBD “presents a good safety and tolerability profile” and approved CBD products, up to a maximum of 150 mg/day, for use in adults, to be supplied over-the-counter by a pharmacist, without a prescription.[2] The United Kingdom’s Food Standards Agency determined that CBD products can be regulated and marketed as novel foods, provided they meet standards for safety and content, recommending a 70mg daily limit for healthy adults.[3]

 

The animal studies conducted by GW Pharma as part of their studies of Epidiolex, and which have been in the possession of the FDA since well before the 2018 Farm Bill, also support a NOAEL for CBD at the low milligram levels found in Dietary Supplements/Foods/Cosmetics currently on the market.

 

The current regulatory environment is a disincentive for companies to invest the substantial amounts of money required for safety studies. Despite the economic disincentive our company, cbdMD, invested over

$1MM to conduct extensive toxicity studies in order to establish the safe serving size for our ingredient, as is required under Title 21. We are aware of several other responsible companies who have done the same. We are also aware that many of those companies, ourselves included, have offered our data to the FDA if they would openly and honestly review it, but such offers were met with a blanket rejection due to the misapplication of drug exclusion.  Proper regulation of hemp cannabinoids as food, dietary supplements or food additives under current authorities in Title 21 would require all companies to conduct safety studies in order to keep products on the market. Again, a federal framework utilizing current authorities would help ensure that CBD and other cannabinoid products sold as food or dietary supplements do not exceed levels that may be unsafe, and importantly, that such products are only marketed to healthy adults and those who are not pregnant or nursing.

 

12. What actions, if any, should the Federal government take to better understand the potential benefits or harms of CBD products and other cannabinoids?

 

We do not believe any further actions are needed to better understand the potential benefits or harms of hemp derived cannabinoids. At this point there is not much hope that the FDA will act in a reasonable and responsible manner with regards to this subject. The body of evidence on safety and efficacy has grown throughout the world despite the FDA’s failures to honestly analyze the safety and efficacy of cannabinoids. The Agency has received millions to study the safety of CBD over the last few years. They have released studies touted to be dietary supplement studies that are nothing more than thinly veiled drug studies that were not designed to derive a NOAEL. If the Agency were to review the safety studies on CBD that have been completed to date and offered to them by responsible companies they would have the information they need to better understand the safety profile of CBD. The safety of other hemp-derived products can be evaluated using the same approaches already in place for other dietary ingredients, i.e., under existing frameworks. The Agency is not tasked or responsible for understanding the benefits of any dietary supplement, including CBD.