08.23.23
It’s the unanimous belief of five dietary supplement trade associations that FDA should utilize the existing regulatory framework on dietary supplements to regulate CBD products, and that Congress shouldn’t afford the agency with a new set of rules. All five consider FDA’s request to Congress for a new regulatory pathway for CBD to be unnecessary, and that FDA should consider CBD-containing products to be dietary supplements and not a unique class of products.
Judging by statements made at a first-of-its-kind House Subcommittee hearing, the first of its kind on CBD’s legal pathway to market, it’s clear that opinions among legislators are mixed when it comes to whether Congress should afford FDA its requested new set of rules to regulate CBD as its own product category.
FDA Could be Regulating CBD Today
Following comments submitted by the Council for Responsible Nutrition and Natural Products Association earlier this week in response to a Congressional Request for Information (RFI) on a regulatory fix for CBD, three more trade associations also agreed that the dietary supplement rule set is enough to maintain quality and consumer safety. The joint statement was made by the American Herbal Products Association (AHPA), United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA).
In the five years since the 2018 Farm Bill removed CBD and other hemp-derived cannabinoids from the list of scheduled drugs, the FDA has objected to using its current regulatory authority to perform any kind of enforcement against CBD-containing products, the three groups argued. Meanwhile, CBD-containing products have proliferated, with zero quality controls in place due to the absence of FDA enforcement.
“FDA could today, under its current authority and in the existing regulatory framework, move CBD containing dietary supplements out of the shadows and into the bright light of regulatory compliance,” said Michael McGuffin, AHPA president. “AHPA remains committed to advocating for FDA's prompt initiation of rulemaking to grant an exception to the exclusionary clauses for CBD as a dietary supplement, with appropriate controls, under the existing regulatory framework.”
Much like the comments submitted by NPA and CRN, the three other trade groups characterized FDA’s inaction as having harmed consumer safety, as well as all businesses dealing in hemp-derived CBD. The three other trade groups also noted that the agency has been inconsistent in its positions – the agency only began requesting a new regulatory path for CBD in 2022 after years in which it considered CBD to be classified as a drug due to the introduction of Epidiolex, which contains extremely high doses of CBD, to the market.
But FDA has always had the authority under existing federal regulatory framework to engage in independent rulemaking on its own to approve of CBD-containing dietary supplement products.
“Clearly, the Congress did not intend the approval of an article as a new drug prior to its marketing as a dietary supplement to automatically preclude its sale as a dietary supplement for all time,” AHPA, UNPA, and CHPA jointly argued. “Resolution of the legal status of CBD through application of the Secretary’s authority to grant an exception to the exclusionary clause provisions would solve one piece to the CBD regulatory puzzle, after which other challenges, including the key issue of product safety, can be addressed through existing laws and regulations.”
For instance, “there is nothing to prevent FDA from granting this exception with whatever conditions it may establish, through a science-based process, as necessary to ensure that CBD containing dietary supplements are reasonably expected to be safe. The Agency could, for example, grant this exception only for dietary supplements that contain no more than a specified quantitative limit of CBD and of delta-9 THC (or total THC), and that contain only plant-derived cannabinoids. The Agency could also limit an exception to the exclusionary clause provisions to CBD dietary supplements that are labeled with appropriate warning or usage instruction, for example, to exclude certain populations, such as children and pregnant women, or to limit dosage and duration of use,” the three associations concluded.
CbdMD: FDA is Concerned with Pharma IP Over Safety
Along with many other companies, hemp-derived CBD manufacturer CbdMD, Inc. also submitted comments, agreeing with the trade organizations that offering FDA a new regulatory path for CBD products is unnecessary.
“The FDA has spent more time plotting their public relations campaign to malign hemp-extract cannabinoid ingredients than they have spent addressing any public health matter and reasonably regulating these ingredients under their current authorities provided in existing frameworks. The real issue is about the role of natural products and pharmaceutical IP in the marketplace and the FDA’s historical refusal to properly recognize natural products in that ecosystem,” wrote Dr. Sibyl Swift, CbdMD’s chief science officer. "The Dietary Supplement Health and Education Act (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. That is just not the case for CBD products sold as dietary supplements, foods, and cosmetics. Congress's intent from the start was clear, that articles could exist at the same time as both a drug and a dietary supplement, and that such articles could continue to exist as a dietary supplement so long as it is properly labeled and marketed."
Judging by statements made at a first-of-its-kind House Subcommittee hearing, the first of its kind on CBD’s legal pathway to market, it’s clear that opinions among legislators are mixed when it comes to whether Congress should afford FDA its requested new set of rules to regulate CBD as its own product category.
FDA Could be Regulating CBD Today
Following comments submitted by the Council for Responsible Nutrition and Natural Products Association earlier this week in response to a Congressional Request for Information (RFI) on a regulatory fix for CBD, three more trade associations also agreed that the dietary supplement rule set is enough to maintain quality and consumer safety. The joint statement was made by the American Herbal Products Association (AHPA), United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA).
In the five years since the 2018 Farm Bill removed CBD and other hemp-derived cannabinoids from the list of scheduled drugs, the FDA has objected to using its current regulatory authority to perform any kind of enforcement against CBD-containing products, the three groups argued. Meanwhile, CBD-containing products have proliferated, with zero quality controls in place due to the absence of FDA enforcement.
“FDA could today, under its current authority and in the existing regulatory framework, move CBD containing dietary supplements out of the shadows and into the bright light of regulatory compliance,” said Michael McGuffin, AHPA president. “AHPA remains committed to advocating for FDA's prompt initiation of rulemaking to grant an exception to the exclusionary clauses for CBD as a dietary supplement, with appropriate controls, under the existing regulatory framework.”
Much like the comments submitted by NPA and CRN, the three other trade groups characterized FDA’s inaction as having harmed consumer safety, as well as all businesses dealing in hemp-derived CBD. The three other trade groups also noted that the agency has been inconsistent in its positions – the agency only began requesting a new regulatory path for CBD in 2022 after years in which it considered CBD to be classified as a drug due to the introduction of Epidiolex, which contains extremely high doses of CBD, to the market.
But FDA has always had the authority under existing federal regulatory framework to engage in independent rulemaking on its own to approve of CBD-containing dietary supplement products.
“Clearly, the Congress did not intend the approval of an article as a new drug prior to its marketing as a dietary supplement to automatically preclude its sale as a dietary supplement for all time,” AHPA, UNPA, and CHPA jointly argued. “Resolution of the legal status of CBD through application of the Secretary’s authority to grant an exception to the exclusionary clause provisions would solve one piece to the CBD regulatory puzzle, after which other challenges, including the key issue of product safety, can be addressed through existing laws and regulations.”
For instance, “there is nothing to prevent FDA from granting this exception with whatever conditions it may establish, through a science-based process, as necessary to ensure that CBD containing dietary supplements are reasonably expected to be safe. The Agency could, for example, grant this exception only for dietary supplements that contain no more than a specified quantitative limit of CBD and of delta-9 THC (or total THC), and that contain only plant-derived cannabinoids. The Agency could also limit an exception to the exclusionary clause provisions to CBD dietary supplements that are labeled with appropriate warning or usage instruction, for example, to exclude certain populations, such as children and pregnant women, or to limit dosage and duration of use,” the three associations concluded.
CbdMD: FDA is Concerned with Pharma IP Over Safety
Along with many other companies, hemp-derived CBD manufacturer CbdMD, Inc. also submitted comments, agreeing with the trade organizations that offering FDA a new regulatory path for CBD products is unnecessary.
“The FDA has spent more time plotting their public relations campaign to malign hemp-extract cannabinoid ingredients than they have spent addressing any public health matter and reasonably regulating these ingredients under their current authorities provided in existing frameworks. The real issue is about the role of natural products and pharmaceutical IP in the marketplace and the FDA’s historical refusal to properly recognize natural products in that ecosystem,” wrote Dr. Sibyl Swift, CbdMD’s chief science officer. "The Dietary Supplement Health and Education Act (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. That is just not the case for CBD products sold as dietary supplements, foods, and cosmetics. Congress's intent from the start was clear, that articles could exist at the same time as both a drug and a dietary supplement, and that such articles could continue to exist as a dietary supplement so long as it is properly labeled and marketed."
