The US hemp ingredient industry, consumers and anyone else waiting for the lawful use of hemp-derived ingredients in dietary supplements have another seasonal reminder that the Food and Drug Administration doesn’t recommend hemp-containing entrees with Thanksgiving meals.
Three years after it marked Thanksgiving week with a larger number or similar warnings to make the same point, the FDA on 21 November announced warning letters to five US firms about using in food or beverage products cannabidiol, the cannabinoid derived from hemp most commonly found in the US marketplace, and delta-8 tetrahydrocannabinol, a subject of ongoing discussion over whether it qualifies as hemp. One firm also was warned about using CBD in a sunscreen product and several about using hemp ingredients in products for animals as well as humans.
With four of the five offering CBD and delta-8 THC in lollipops, other candy forms and cookies, the agency says in warnings to those firms that it “is particularly concerned that some of your products are in forms that are appealing to children.”
“The warnings are somewhat consistent with the FDA’s previous warning letters in that they allege the recipient company is selling an adulterated food product, mislabeling their products, potentially causing consumer confusion, and that the company’s marketing allegedly targets children,” said attorney Rachel Gillette, a partner Holland & Hart LLP in Denver and leader of its Cannabis Industry Group.
However, three of the five warned by the Office of Compliance in the Center for Food Safety and Applied Nutrition and the Office of Unapproved Drugs and Labeling Compliance in the Center for Drug Evaluation and Research weren’t making drug claims for their food or beverage products
“CBD product retailers and manufacturers are often confused by the FDA’s position on CBD in food or pet products and dietary supplements and how that position comports with state laws allowing their manufacture and sale, and claims that hemp derived CBD products are ‘legal in all fifty states’,” Gillette said in an email responding to HBW Insight questions.
“The reality is it is a confusing legal landscape and it does not help that the FDA is silent on many other hemp-derivative cannabinoid products and the products are literally sold everywhere.”
‘Know Of No Basis For’ GRAS
The FDA centers repeatedly make clear in their warnings to those three – mood33 LLC in Newtown, PA, dba as 11-11-11 Brands; CBD American Shaman LLC in Kansas City, MO; and Infusionz LLC in Henderson, NV – that the agency doesn’t need to find violative claims about hemp ingredients preventing or treating a disease to deem unlawful the ingredients’ use in food and beverages.
Identifying CBD or any hemp ingredient as a “food additive” – any substance with an intended use as a component of any food, unless the substance is generally recognized as safe among qualified experts under the conditions of its intended use, the centers state in each of the five warnings, “There is no food additive regulation which authorizes the use of CBD.”
The warnings also advise, “FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food.”
Additionally, the centers quash any argument that hemp was used as an ingredient in food or beverage products available in the US ingredient before the botanical, as part of cannabis, was studied for use as a drug: “We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958.” American Shaman and Infusionz are among the four firms warned about marketing products attractive to children.
The other two firms, Naturally Infused LLC in New Port Richey, FL, and Newhere Inc. dba CBDFX, in Chatsworth, CA, also were warned about human and animal drug claims for hemp-containing food and be beverages and about during delta-8 THC in their products.
While delta-8 THC is like other hemp ingredients in that it hasn’t been evaluated or approved by FDA for safe use and it may be marketed in ways that put the public health at risk, the warnings state that the FDA is concerned delta-8 THC has psychoactive and intoxicating effects, about processes used to create concentrations claimed in the marketplace and products that may be consumed by children due to their packaging and labeling.
The warning to American Shaman also states it was marketing a sunscreen product labeled as containing CBD, which is noncompliant with the FDA’s OTC monograph for sunscreen formulations. “CBD is not an active ingredient allowed in any applicable final monograph,” the CDER and CSFAN offices state, adding that classifying CBD as an inactive ingredient in the product also would be violative.
American Shaman isn’t the first US business warned about using CBD in a product sold as an OTC drug. In May 2021, the FDA warned a Wisconsin physician that the CBD-containing nasal sprays and topical and animal drugs he was marketing were unapproved new drugs. (Also see “Wisconsin Doctor’s CBD Nasal Sprays, Topical Offered OTC Diagnosed As Unapproved Drugs” – HBW Insight, 3 Aug, 2021.)
‘Consumers May Confuse With Traditional Foods’
Another strike against mood33 without connection to making drug claims or to offering products attractive to children was the form of its products.
The CDER and CFSAN offices say they are “particularly concerned that your products are in a form (herbal tea or beverage) that consumers may confuse with traditional foods” and that some of the products also appear to contain caffeine. “Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects,” the warning states.
The warning to the Pennsylvania firm reflects the FDA’s intention it explained in 2019 with its initial batch of warnings to firms marketing food or beverage products or dietary supplements containing CBD or other ingredients derived from hemp. Saying then it was not aware of evidence supporting CBD as GRAS, the FDA pointed to NDI notifications as the only option that manufacturers, marketers and other businesses would have to convince the agency about reasonable expectations of safety for CBD and other hemp-derived substances used in supplements. (Also see “Future Of CBD In Supplements: NDI Notification Looms As Regulatory Path ” – HBW Insight, 3 Dec, 2019.)
Hemp was de-scheduled as a controlled substance in the 2018 farm bill, legislation defining hemp as any part of the cannabis plant containing no more than 0.3% delta-9 THC by dry weight but maintaining the FDA’s authority over the substance’s use in any product subject to its regulatory oversight. That meant hemp was prohibited from use in food, beverages and supplements marketed in the US because it already had been studied or approved as a drug.
The FDA, under enforcement discretion, would allow marketing of hemp-containing supplements made, labeled and marketed with all other relevant regulations, but it didn’t intend to allow hemp ingredients’ use in products marketed as food and beverages.
The FDA also has pointed out consumers typically don’t track intakes of ingredients in foods. Allowing cannabinoids in food would run a risk of consumers using unknown amounts of the ingredients from multiple food products daily in addition to taking cannabinoid-containing supplements.
FDA officials have acknowledged the agency needed to determine whether to allow lawful use of hemp in supplements but also suggest that rulemakings typically extend for multiple years and lawmakers could expedite the changes through legislation. (Also see “CBD Public Hearing Could Extend FDA’s Hand Further For Help From Congress” – HBW Insight, 29 May, 2019.)
Numerous bills have been introduced since then, either as standalone legislation or as provisions added to broader legislation, to authorize the FDA to establish lawful use of hemp ingredients in supplements. A Senate bill introduced during the current session included food products, but lawmakers otherwise have limited their legislation to affecting hemp ingredients’ use in supplements. (Also see “Mixing Food In Legislation Changing US FDA Cannabinoid Rules Could Choke Its Progress” – HBW Insight, 25 May, 2021.)
Until a regulation for lawful use is in place, hemp food, beverage and supplement product businesses should to expect the FDA not only will continue to make them aware their products are available currently under enforcement discretion, but conduct additional enforcement, Gillette observed.
“I think the federal government moves incredibly slowly. There will eventually be federal regulation and hopefully that comes with more clarity, but until that happens, the FDA is going to remind the industry that it is watching and it can and will enforce when necessary. Sure, today these companies may only get a letter, but don’t think for a second the FDA or other federal regulatory agencies aren’t willing to ‘make an example’ out of any one company,” she said.
House appropriators, in a report accompanying legislation for the FDA’s fiscal year 2023 budget, stated they expect CBD to be the “one” hemp ingredient that will be deemed lawful for use in supplements, a designation potentially answering all questions or raising more about the future of the hemp product market. (Also see “CBD Will Be US FDA’s ‘One’ Lawful Hemp Compound, House Appropriators Anticipate” – HBW Insight, 13 Jul, 2022.)
The committee members’ statement about hemp ingredients was more pointed than in previous reports they’ve published with their annual Department of Agriculture, Rural Development, FDA and Related Agencies appropriation bill.
The use of delta-8 THC in food or supplements not only is a concern to the FDA, it also is a top sales driver in the hemp market. (Also see “Emerging US Cannabinoid Market Sales Driver Could Drive Lawful Use Legislation Off The Rails” – HBW Insight, 30 Aug, 2021.)
The agency’s previous warnings about unlawful claims for products labeled as containing delta-8 THC also stated concerns about it safety. (Also see “First US Warnings On Drug Claims By Delta-8 THC Supplements Also Describe Safety Concerns” – HBW Insight, 4 May, 2022.)
However, with delta-8 ingredients meeting the farm bill’s definition of hemp as any part of the cannabis plant containing no more than 0.3% delta-9 THC by dry weight, proponents contend supplements and other products containing the ingredients aren’t in violation of the farm bill’s de-scheduling of hemp.
Prior to Congress considering legislation to change the FDA’s rules on hemp-derived cannabinoids, the FDA in 2019 opened a docket for comment, and has since deemed it open indefinitely – FDA-2019-N-1482, on proposing a rulemaking to open a regulatory pathway for using the ingredients in products other than drugs subject to its oversight.