CBDMD Response to Congressional Request for Information Page2

1. How should a new framework for CBD products balance consumer safety with consumer access?

 

We do not believe a new framework is necessary and we do not support a new framework for ingestible or topical CBD products classified as food, dietary supplements, or cosmetics. We support the existing Federal framework within the FDCA that has a proven track record for effectively balancing consumer safety with access. Rather than criminalize or prohibit products, utilizing the existing framework would make all hemp cannabinoid products accessible to consumers through appropriate channels. FDA would regulate non-impairing hemp products and apply the same robust manufacturing, labeling, and safety standards applicable to all food, dietary supplements, and cosmetics. Products that may be impairing would be strictly regulated in an adult-only framework by a separate agency such as TTB. This approach would be quick and easy to implement with minimal expenditures of public dollars, and would ensure consumers have immediate access to safe, quality products.

 

1. Some stakeholders have raised concerns that CBD products have inherent risks. What are those inherent risks, and at what levels of CBD do those risks present themselves? What data and other evidence support the existence of such risks, and from which products are such data and evidence derived?

 

Please see response to Question 11.

 

We are aware that CBD can present risks (e.g., liver and reproductive toxicity) at higher amounts such as those indicated to treat serious disease (e.g., the drug Epidiolex® is an FDA-approved prescription medication containing high doses of purified CBD intended to treat certain seizure disorders). However, as noted in our response above, recommended levels for safe use can be derived based on the available data, and these levels are much lower than the high levels indicated to treat disease. The typical dosage of Epidiolex® can range from 700 milligrams to over 1500 milligrams. By contrast the typical serving size of most CBD foods and supplements sold at retail is below 150 milligrams, and a range of data clearly demonstrates these lower levels present a low risk profile for healthy adults..

 

15. FDA approved Epidiolex, a drug containing CBD, based in part on a data package that included preclinical data from rodent safety models, as well as clinical trials. FDA has received safety data on CBD products from several manufacturers also based on rodent models. How should FDA consider data submitted for a CBD-containing drug as evidence to support that CBD is safe for human consumption in non-drug products, recognizing the inherent differences in the intended uses of such products?

 

Like all drug data submissions, the data package for Epidiolex® is the most comprehensive available and provides “important information that can be incorporated into an assessment of CBD consumer safety.” We agree this data is relevant to the extent it indicates that the risk of adverse events (e.g., liver toxicity) increases as the dosage of CBD increases, which is consistent with other safety and toxicological data on CBD. There is a growing body of scientific evidence demonstrating the safety of CBD at lower milligram amounts, such as the amounts typically found in CBD food and dietary supplement products sold at retail. Thus, the entire range of data on CBD – preclinical data from rodent safety models and other toxicological data, human clinical trials, observational data, and adverse event reports – should be considered in its entirety, as well as the intended use and target population of a given product. Ultimately, a NOAEL must be established by each company that places an article into commerce. This well established rule provides clarity and accountability and is based on science which is peer reviewed for completeness and accuracy. There is no need to seek out new pathways or new methods when this method has worked to protect public health for decades and is beyond reproach. It belies a hidden agenda to suggest otherwise.

 

1. Should there be limits on the amount of CBD in foods, dietary supplements, tobacco, or cosmetics? If so:

 

Yes. As there are with every other product on the market. The determination of a NOAEL for Dietary Supplements, or safe daily consumption levels for Foods/Food Additives, or unsafe conditions of use for Cosmetics, provides the necessary guardrails. All responsible companies in this industry welcome the idea of reasonable, science-based limits on CBD per serving in foods and dietary supplements. We do not believe limits are warranted for CBD in cosmetics. We take no position on CBD limits for inhalable products. Limits for ingestible hemp cannabinoids used in food or dietary supplements can be established using the available body of evidence and, under current authorities, each manufacturer of a hemp cannabinoid ingredient would be required to reasonably demonstrate safety through a NDIN or GRAS process, as is required under DSHEA for any new dietary ingredient introduced after October 15, 1994

1. Should Congress or FDA set such limits, recognizing the time it can take to complete the legislative process and the regulatory process at FDA?

 

As the regulatory agency with the appropriate scientific expertise, we believe FDA is in the best position to set such limits via standard notice-and-comment rulemaking. We are also not aware of any precedent for Congress setting limits for a specific food or dietary ingredient via legislation. We recognize rulemaking could take considerable time, and therefore we suggest a reasonable interim limit set via legislation, and vetted through the interim final rulemaking process, or through a policy of enforcement discretion issued by FDA. Congress could look to the WHO or the UK or the TGA, all of which have set some form of baseline limit pending further scientific support by companies to support higher levels.

 

That being said, setting a serving size or daily limit for CBD is not necessary given the existing frameworks for food and dietary supplements. The ingredient safety standards and requirements for dietary supplements and food under the FD&C Act and FDA regulations (e.g., NDI, Self Affirmed GRAS, and adulteration provision for supplements, GRAS and food additive requirements for food) contemplate serving size limits based on the intended use of the product and target population, with adequate instructions for use and reasonable warnings. Dietary supplements that contain levels of CBD that pose a significant safety risk are deemed adulterated and are already prohibited under the current regulatory framework. By merely applying the existing rule set, companies would be required to walk through the front door with data in hand to present to the FDA, or would be required to have this information published in peer reviewed journals and available for public and Agency scrutiny. Those without the required data to substantiate their products on the market could be summarily removed. It is just that simple.

 

1. How should that amount be determined? What should the amount be?

 

As stated above, the amount should be determined on an ingredient by ingredient basis as has been required for decades under the FDCA. No new process, framework, or authorities are needed and this could be implemented immediately with the removal of Drug Exclusion. With that said, stakeholder input could be sought for any refinements made to the regulatory framework in the future, i.e., any permanent limits, if necessary, should be established through standard notice-and- comment rulemaking procedures. Moreover, scientific data and empirical evidence should drive the regulatory standards. Published data from clinical studies supports a dose of 150 to 160 mg/serving would be safe for healthy adults..

 

1. Should such limits be applied on the amount per serving, and/or per package?

 

Limits should be applied per serving, rather than per package, and be based on the safety data compiled by each company specific to their ingredient and indications of use. Dietary supplements are often packaged to provide a 30-, 60-, or 90-day supply of the product, and include instructions for use that direct users not to consume more than the recommended serving per day. We are not aware that consumers are misusing CBD products by consuming the entire package at once. We are also not aware of any other instances of per-package limits being set for Dietary Supplements/Foods/Cosmetics.

 

FDA has previously addressed a situation where they opted for serving limits, rather than package limits. In and around 2017-2018, dietary supplements containing highly concentrated caffeine in a form that prevented reasonable consumers from measuring a single serving were flooding the market. In response to this issue FDA published a guidance document, “Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry” in 2018.[4] Dr. Sibyl Swift, currently the CSO of cbdMD, and the co-author of this RFI response, played an integral part in the drafting of this Guidance while she was at the FDA. The Guidance was drafted in a manner to give consumers access to a product that was safe and effective below the set serving limit, but could present serious risk for injury above the serving limit the Agency set. The Agency recognized that consumers should be allowed to make a reasonable choice about their health and wellness without creating unnecessary regulations pertaining to packing limits. Although CBD products clearly do not pose the same safety risks as pure powdered caffeine, if serving size guidance is deemed necessary, we suggest that the Agency be directed to follow a similar process for hemp cannabinoid products.

 

1. Could FDA set such limits under its current statutory regulatory authorities for foods and dietary supplements to potentially address safety concerns, notwithstanding exclusionary clause issues?

 

FDA’s current authorities under the FDCA provide the Agency with the tools to effectively regulate Hemp Derived Products including abundant consumer safeguards. For example, the law precludes manufacturers and distributors of dietary supplements, food, and cosmetics from selling mislabeled or adulterated products. Both food and dietary supplement manufacturers must comply with cGMPs, as well as application provisions of the Food Safety Modernization Act. Soon, cosmetics will also be subject to mandatory cGMPs, product listing, and other requirements due to the passage of MoCRA. Reporting of serious adverse events and adverse event recordkeeping is also required for dietary supplements, and detailed labeling requirements are applicable to all product categories. FDA also has authority to require warnings against the use of products by children or other vulnerable populations, and currently all responsible CBD companies already include such warnings on their product labels. Finally, the FDA with the Consumer Product Safety Commission could require child-proof packaging via regulation, as is already the case for certain iron-containing dietary supplements.[5]

 

e.   How should the experience of states inform the setting of limits on amounts of CBD in products?

 

States are not properly equipped to address these issues and they are mostly political solutions and not science based. Therefore we do not advise the states to serve as a model in this regard. With that said, few states have set limits for hemp-derived cannabinoids. For example, currently, New York imposes a limit of 3,000 milligrams of total cannabinoids per package for orally consumed products, with no more than 100 milligrams of total cannabinoids per individual serving (exclusive of THC); products in the form of a tincture cannot exceed 4,000 milligrams of cannabinoids per package.[6] In general, state requirements for CBD products vary widely, and the current patchwork of state requirements has left both consumers and industry confused. Uniform federal requirements are needed to help ensure consumer health, safety, and transparency in labeling.

 

1. How should a regulatory framework account for CBD products marketed in combination with other substances that may alter or enhance the effects of CBD (e.g., caffeine, melatonin, etc.)?

 

The existing frameworks for food, dietary supplements, and cosmetics already account for the safety of combination products through the applicable adulteration provisions under the FDCA. Thus, CBD products should not be subject to additional regulatory requirements concerning combination products.

 

1. What precedent is there for FDA restricting certain otherwise allowable ingredients in legally marketed products? What amount and type of evidence has been required/demonstrated to support any such restrictions?

 

See our response to 16 (c) above. This precedent was set when ingredients presenting serious risk of illness and injury after their consumption was linked to several consumer deaths in 2018. Hemp cannabinoid products do not present a risk for serious illness or injury when formulated as we have described in this document.

 

1. What functional ingredients combined with cannabinoids raise safety concerns?

 

There are no known safety concerns with regards to any specific functional ingredient when combined with cannabinoids, other than what would be present with any such specific functional ingredient by itself. As described above, existing frameworks for food, dietary supplements, and cosmetics already address adulterated products, including combination products. The current regulatory framework places the onus on manufacturers to demonstrate that their products, and all of the ingredients contained within, are safe according to the conditions for use.

 

Quality

 

20. How should Congress create an FDA-implemented framework to ensure that manufacturers provide appropriate consumer protections and quality controls?

 

Congress does not need to create a new manufacturing framework for dietary supplements, food, or cosmetics, as the existing cGMPs for dietary supplements and food and future cGMPs to be developed by FDA for cosmetics will provide appropriate consumer safety standards and quality controls. 

 

1. How should such a framework compare to the current Good Manufacturing Practice (cGMP) requirements that apply to food, dietary supplements, and cosmetics?

 

A new framework is unnecessary given cGMPs for food and dietary supplements are already in place and have a proven track record.

 

1. Are those food, dietary supplement, and cosmetics GMP frameworks adequate for regulating quality in CBD? Why or why not?

 

Yes. The existing cGMP framework is more than adequate. The existing cGMP frameworks for food and supplements cover a range of mandatory compliance areas including: in process controls, manufacturing, quality and others. They are also fully auditable and can be validated by third party Certifying Bodies. We anticipate that the cGMPs for cosmetics, once established, will cover similar areas. In addition, federal law (and state law) already precludes manufacturers and distributors from selling mislabeled or adulterated products, including products that fail to comply with cGMP requirements for food and supplements.

 

Existing frameworks also provide for FDA facility inspections to ensure compliance with cGMPs and prevent adulterated products from entering the marketplace, and to issue Warning Letters in cases of non-compliance. Where there are instances of repeated violations, FDA could coordinate with the Department of Justice to seek an injunction.[7]

 

21. What are alternative quality approaches that Congress should consider for CBD products? For example, how should third parties be leveraged for the creation and auditing of manufacturing and testing requirements?

 

We believe the current market conditions for Dietary Supplements/Foods/Cosmetics are robust and provide adequate safeguards. We believe that industry self-regulation can complement federal and state regulation. Further, with clear regulations the market will regulate itself as retailers will look to responsible suppliers who can document their cGMP compliance and those who cannot will be naturally excluded from the market. By way of example, in 2019, NSF began certifying CBD and hemp products. NSF certifies products to NSF/ANSI 173/455 (Dietary Supplements Contents Certified), NSF 229 (Functional Foods), NSF 306 (NSF Certified for Sport®), and NSF 527 (Personal Care Contents Certified).[8] NSF’s certification program helps ensure products do not contain unacceptable levels of contaminants, including those specific to hemp, like THC and certain solvents and verifies the validity of label claims. Finished products seeking NSF Certified for Sport® certification must meet the additional strict THC requirements of NSF 306 in addition to the over 280 banned substances banned by professional sports leagues and anti- doping organizations. In addition, NSF GMP certification (for dietary supplement, functional foods or cosmetic  and  personal  care  manufacturers  or  packers)  or  registration  (for  dietary  ingredient manufacturing) provides consumers and retailers, as well as regulators, with assurance that products produced are consistent with GMPs, appropriate quality-control procedures and industry best practices. Several retailers have implemented across the board requirements for all products they sell to be certified by NSF, or in some cases by a comparable third party Certifying Body, which is how the natural progression of the market works to include responsible companies and exclude those who are not able to meet the required standards. 

Form, Packaging, Accessibility, and Labeling

 

1. What types of claims should product manufacturers be permitted to make about CBD products? Please reference how such permitted claims compare to the types of claims that may be made about drugs, foods, dietary supplements, and cosmetics.

 

We believe that CBD fits into the existing frameworks for foods, dietary supplements, and cosmetics. Therefore, CBD products should be permitted to make structure/function claims in accordance with 21

C.F.R. § 101.93. The FDCA and laws enforced by the Federal Trade Commission prohibit the labeling and marketing of products with unlawful claims and untruthful, unsupported, misleading claims.

 

1. What is the evidence regarding the potential benefits of including a symbol or other marking on product labeling to provide clarity for consumers who would purchase products that contain CBD?

 

There is no evidence or reasonable need for a special symbol or other marking on a non-intoxicating hemp cannabinoid product. We are aware of a handful of states that require a symbol or marking on certain hemp cannabinoid products. It makes reasonable sense to include some form of symbol on a product which contains potentially impairing cannabinoids or those which could result in a failed drug test. We are not aware of any evidence regarding the efficacy or potential benefits of requiring such a symbol or marking. We support the addition of a THC symbol on products that are manufactured with hemp containing less than 0.3% THC by weight and less than 5 milligrams of THC per serving if it is detectable by industry accepted testing standards to inform consumers when they may ingest a product that could lead to them failing a drug test for detectable THC.

 

1. What are the potential benefits or drawbacks of an additional or substitute standardized label panel for CBD products, compared to the current Nutrition Facts Label and Supplements Label?

 

The existing labeling regulations for food and dietary supplements are sufficient. We do not support additional label panels for CBD products in lieu of Nutrition Facts or Supplement Facts panels or labels. New facts panels would be confusing and require additional space on labels which might not be available on smaller package sizes found in dietary supplements. The current rules are robust and comprehensive with regards to how to label botanically derived ingredients, including the latin binomial and part of the plant from which the ingredient is derived.

 

1. What precedent exists in foods, dietary supplements, tobacco, and cosmetics for requirements of labeling to present risks to special populations in labeling (e.g., children, pregnant and lactating women, consumers taking certain drugs, etc.)? What amount and type of evidence has been required to support such requirements?

 

As discussed above, the FDCA prohibits the distribution of adulterated food, dietary supplements, and cosmetics, and products are considered misbranded if their labeling is “false or misleading in any particular” – which is a broad prohibition that covers labeling that omits warnings that are necessary to ensure safe use, including by vulnerable populations.[24] Responsible companies are already labeling products for full consumer transparency, either on a voluntary basis or to comply with state mandates. For example: 

• Restricting sales of CBD and other cannabinoids products to consumers 18 and older;
• Restricting sales of THC-containing products to consumers 21 and older;
• Use of child-resistant and tamper-evident packaging on products containing THC;
• Clear and consistent labeling with marketed cannabinoids and THC milligrams disclosed in Supplement Facts panels;
• Including QR codes or similar scannable codes on labels that provide access to a product’s Certificate of Analysis (COA) that includes milligrams of marketed cannabinoids and THC, as well as levels of pesticides, residual solvents, microbials, mycotoxins, and heavy metals;
• Use of product warnings, e.g., advising consumers who have a medical condition or are pregnant, nursing, under 18, or taking medication not to consume the product or to consult a healthcare practitioner prior to use, and for products containing THC, that consumption of the product may lead to a positive drug test.
• Ensuring product packaging, labeling, and marketing is not attractive to children, and that products are not marketed for their impairing or intoxicating effects.

 

The existing regulations currently prescribe the format and placement of the warnings, e.g., requiring a warning to appear prominently and conspicuously on the principal display panel of the package label and any other labeling. FDA has ample authority under existing frameworks to require warnings for vulnerable populations where necessary, and a new framework is not required.

 

1. Some suggest requiring labels for CBD products to include “potential THC content.” Would THC content be unknown in a particular product? Is there precedent for such a labeling requirement?

 

Standard testing available from ISO 17025 certified labs across the United States provide adequate testing to determine if there is any THC or THCA (which could be converted to THC after consumption) that is contained in a hemp cannabinoid product. There is no basis for claiming the amount of THC in any hemp cannabinoid product could not be determined. We are not aware of any precedent for a labeling requirement regarding “potential THC content” and would oppose such a requirement due to its likelihood to cause confusion.

 

1. How should access to CBD products by children be regulated? For example, would it be appropriate to have an age restriction on the purchase of CBD products? If so, what is an appropriate age limit?

 

We support requiring child-resistant packaging by adding cannabinoids derived from Cannabis sativa L. to the list of substances requiring special packaging.[31] We also support restrictions on product formats that resemble candy or snacks; labeling depicting characters, animals, vehicles, or fruit; and products in the shape of characters, animals, vehicles, or fruit.

However, we oppose prohibitions such as a ban on the use of “bright colors” for products and packaging, as this would unnecessarily limit the formulation of flavored, non-intoxicating products. We also want to ensure that gummies—which are a standard, safe, and widely used product format within the dietary supplement industry—are not included in the prohibitions against candies.

We are open to age restrictions for the sale of non-intoxicating products, provided our concerns regarding serving sizes and THC/CBD content are addressed. If there must be age limits, we believe the appropriate benchmark should be 18, whereby consumers under this age could not purchase products. For impairing products, under our proposed TTB framework, these products would be restricted to consumers 21 and older. 

 

28. What specific additional restrictions should apply to CBD products regarding their appeal to or use by children with regard to marketing, packaging, and labeling? Is there precedent in the food, dietary supplement, tobacco, or cosmetics space for restricting certain product features that would make products appealing to children? Please describe.

 

Please see our response to Question 27.

 

29. Some suggest requiring packages with multiple servings to be easily divisible into single servings. Does a framework like this exist today for any other product or substance?

 

We are opposed to requiring packages with multiple servings be easily divisible into single servings. Existing dietary supplement regulations address product packaging and adequate means for delivering a single serving according to the conditions for use.

 

[1] World Health Organization, CANNABIDIOL (CBD) Critical Review Report, Expert Committee on Drug Dependence Fortieth Meeting, Geneva, 4-7 June 2018, available at: https://www.who.int/docs/default- source/controlled-substances/whocbdreportmay2018-2.pdf.

[2] Australia Therapeutic Goods Administration, Over-the-counter access to low dose cannabidiol (December 2020), available at: https://www.tga.gov.au/news/media-releases/over-counter-access-low-dose-cannabidiol.

[3] United Kingdom Food Standards Agency, Food Standards Agency sets deadline for the CBD industry and provides safety advice to consumers (May 2022), available at: https://www.food.gov.uk/news-alerts/news/food- standards-agency-sets-deadline-for-the-cbd-industry-and-provides-safety-advice-to-consumers.

[4] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-highly- concentrated-caffeine-dietary-supplements.

[5] 21 C.F.R. § 101.17, available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part- 101/subpart-A/section-101.17.

[6] N.Y. Comp. Codes R. & Regs. tit. 9 § 114, available at: https://cannabis.ny.gov/system/files/documents/2021/11/part_114_cannabinoid_hemp_regulation_11-10-21.pdf.

[7] See, e.g., Federal judge enters permanent injunction against New York-based dietary supplement manufacturer (Mar. 2021), available at: https://www.fda.gov/news-events/press-announcements/federal-judge- enters-permanent-injunction-against-new-york-based-dietary-supplement-manufacturer; Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations (Sept. 2019), available at: https://www.fda.gov/news- events/press-announcements/federal-judge-enters-consent-decree-against-tennessee-drug-dietary-supplement- and-device.

[8] NSF, CBD and Hemp Product Certification, available at: https://www.nsf.org/health/dietary-nutrition- supplements-personal-care-products/nutritional-supplements-cosmetics-personal-care-products/hemp-and- hemp-derived-cbd-product-certification.

 

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