FDA slammed for perpetuating “confusion and gray area” in CBD supplement regulation
The US food and drug agency holds its ground that risks run too high to allow the ingredient to be openly marketed
07 Feb 2023 --- Nutritional associations have “expressed dismay” following the US Food and Drug Administration’s (FDA) rejection of three citizens’ petitions to legally allow the marketing of cannabidiol (CBD) in dietary supplements.
The dismissal means further delay in finding a regulatory framework for CBD – an ingredient that is rapidly gaining traction across a range of categories that the FDA regulates, spanning supplements, foods, beverages, cosmetics and drugs.
“Indecision to regulate CBD has been the decision for far too long, and as a result, a confused marketplace of unregulated CBD products has emerged that does not serve the public health,” Duffy MacKay, senior vice president of supplements at the Consumer Healthcare Products Association (CHPA) tells NutritionInsight.
However, the FDA contends that marketing CBD without proper approvals can have far-reaching health implications.
“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective,” an FDA spokesperson tells NutritionInsight.
A tricky, gray area
President and CEO of the Council for Responsible Nutrition (CRN), Steve Mister, warns that the FDA is ignoring the realities of the current marketplace.
“FDA’s inaction and indecision have frustrated consumer interest in having safe and beneficial CBD products available to them and allowed a ‘gray’ CBD marketplace to emerge without meaningful oversight,” he says.
Marketing and labeling laws vary from state to state in the US, compounding confusion at a national level.
MacKay explains: “In states that have passed laws allowing the sale of hemp-derived products, companies may lawfully market these products based on that state’s manufacturing, labeling and marketing rules. Some states even have product and facility listing requirements and require a QR code to be placed on the label as an added precaution.”
“However, FDA has made it clear that these products should not be labeled as Dietary Supplements or Conventional Food and sold across state lines, or they are considered adulterated.”
He anticipates that the FDA maintaining the status quo will likely increase market and consumer confusion in states with laws that allow the sale of CBD products.
The FDA spokesperson adds that while interstate commerce is not allowed, often CBD products are sold online and are therefore available throughout the country.
Fears of misleading marketing
The FDA argues that there is still not enough evidence to show that CBD is safe, especially in vulnerable populations such as pregnant women.
An agency spokesperson says the FDA “continues to be concerned by the proliferation of products that contain CBD that are marketed for therapeutic or medical uses.”
Moreover, “deceptive marketing” of unproven treatments raises significant public health concerns because patients and other consumers may be influenced not to use approved drugs to treat serious and even fatal diseases, they add.
CRN disagrees with FDA’s findings, suggesting that the agency is looking only at extreme cases of high-dose CBD in their conclusions.
“During the last four years, FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements and continues to rely heavily on safety concerns related to high dosage Epidiolex to support the agency’s inaction,” says Mister.
“It seems that no level of safety evidence will be good enough for the FDA.”
A question of capacity?
The FDA is responsible for enforcing its rules and regulations, which is part of why there’s frustration surrounding last week’s citizen petition responses, underscores MacKay.
“As FDA itself said in denying our [CHPA’s] petition, ‘FDA does not have the resources to take enforcement action against every violative product in this exploding market.’”
The FDA has repeatedly maintained its stance against CBD by issuing numerous warning letters to companies marketing such as:
- CBD products marketed to treat diseases or for other therapeutic uses
- CBD products for food-producing animals
- CBD-containing products that people may confuse for traditional foods or beverages, which may result in unintentional consumption or overconsumption of CBD and CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies
- CBD products with concerning routes of administration, including nasal, ophthalmic and inhalation
- Delta-8 THC products
The agency says it will continue to monitor the marketplace and take action, as needed, against products that pose a risk of harm to the public.
The FDA spokesperson points out that other countries that currently provide lawful access to CBD products use authorities specifically intended for cannabis products, not their food authorities.
“Australia regulates CBD products through its regulatory framework for medical cannabis, while Canada regulates CBD through its regulatory framework for adult-use cannabis,” notes the spokesperson.
Is new pathway a further delay?
Meanwhile, the FDA recognizes that doing nothing is not an option, and there is a true need for a framework to mitigate risk, which is why it proposes a new regulatory path.
Last month, it announced that its high-level working group, the Cannabis Product Committee (CPC), would work with Congress to explore potential pathways for the lawful marketing of CBD products.
The collaboration would work to establish basic regulations to protect consumers. Examples include clear labeling laws, prevention of contaminants, CBD content limits and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.
The CPC is a large group with members from the Office of the Commissioner, the Office of Regulatory Affairs and the FDA Centers with authorities pertaining to cannabis products.
“FDA has now punted to Congress, and there is no plan to mitigate the risk created by unregulated gray market CBD products that are currently being sold to US consumers,” underscores MacKay.
The timeline for the new regulatory pathway remains to be seen. But both CHPA and CRN say they look forward to working with congressional lawmakers on the next steps.
For CHPA, that will mean helping to modernize the Dietary Supplement Health and Education Act (DSHEA) and to ensure that the “NDI (new dietary ingredient) process works as was originally intended.”
By Missy Green
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