Food Regulatory Update: FDA Issues Final Recall Guidance and Plans Strengthened Dietary Supplement Oversight, States and Cities Ramp Up CBD Enforcement
Despite the cold temperatures across much of the country, federal and state policy, regulatory, and enforcement developments have been heating up in the food and beverage space. In the last few weeks alone:
- The U.S. Food and Drug Administration (FDA or the Agency) issued final guidance regarding public warning and notification of recalls;
- FDA announced plans to strengthen regulation of dietary supplements by modernizing and reforming the Agency’s oversight;
- FDA and the Federal Trade Commission (FTC or the Commission) issued warning letters to a number of dietary supplement companies making unproven claims that their products can treat or cure Alzheimer’s disease and other conditions; and
- A number of states and municipalities, including Maine, Ohio, and New York City, have taken enforcement action against food and beverage products containing cannabidiol (CBD).
On February 7, 2019, FDA announced that it is taking new steps to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls, including issuance of final guidance related to public recall warnings (Final Guidance). As some will recall, in January 2018, the Agency announced a draft guidance for strengthening public warnings and notifications of recalls. This was the first in a series of actions taken by FDA last year related to recalls; the Agency also in September 2018 issued draft guidance that describes situations where FDA will disclose retail information for recalled food products, and in November 2018 finalized mandatory recall guidance for foods.
The Agency's Final Guidance, entitled "Public Warning and Notification of Recalls:"
- Outlines circumstances when a company should, in FDA’s view, issue a public warning about a voluntary recall (e.g., urgent situations and are issued to alert the public that a product being recalled presents a serious hazard to health, and where other means for preventing the use of a recalled product appear inadequate);
- Describes the general timeframe for companies to issue such a warning (generally within 24 hours of the Agency notifying the firm that it believes a public warning is appropriate);
- Discusses what information should be included in a public warning;
- Details situations where FDA may take action to issue its own public warning should a company’s warning be deemed insufficient (e.g., if it does not adequately identify the recalled product, describe the health hazard involved, or identify relevant information about the product’s distribution); and
- Notes the Agency’s policy for moving forward with posting recalls to FDA’s Enforcement Report – an internet listing of all recalls monitored by the Agency – in some cases before a final health hazard evaluation is completed.
Despite the fact that the number of recalls in Fiscal Year 2018 (7,420) represented a five-year low in that figure, consumers may feel like they are seeing more recalls. This is not surprising given the Agency’s more prominent publicizing of recalls, and increased communication directly with consumers regarding the same through FDA’s social media presence.
Overhaul of Dietary Supplement Regulation and Oversight; Enforcement Sweep
On February 11, 2019, FDA announced a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.
The steps announced by the Agency are aimed at achieving the twin goals of ensuring that FDA achieves the right balance between preserving consumers' access to lawful supplements while protecting the public from unsafe and unlawful products. The first step addressed by the Agency is communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that FDA’s regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation. In taking this step, the Agency has indicated that it will continue to both work closely with its industry partners, developing new enforcement strategies, and to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.
Simultaneously with its announcement, the Agency sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat, or cure Alzheimer's disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer. As the Agency was quick to remind the public, dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer's. FTC joined FDA on three of these letters because, per the Commission, the companies' advertisements may violate the FTC Act by making false or unsubstantiated health claims.
FDA also detailed in its announcement that it had established a Dietary Supplement Working Group at the Agency, led out of Commissioner Scott Gottlieb, M.D.’s office and comprised of representatives from multiple centers and offices across FDA. Commissioner Gottlieb has tasked this group with taking a close look at the Agency’s organizational structures, processes, procedures, and practices in order to identify opportunities to modernize FDA’s oversight of dietary supplements.
Among the steps the Agency is considering or actively formulating is developing new ways to communicate more quickly when FDA has concerns that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. More specifically, the Agency is developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with a certain ingredient, and to notify responsible industry participants to avoid making or selling them.
While FDA did not mention cannabidiol (CBD) by name in its February 11th announcement, some will recall that just two months ago, and as we discussed, the Agency reminded the public that, in FDA’s view, it is unlawful under the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) to introduce food containing added CBD or delta-9 tetrahydrocannabinol (THC) into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. The Agency included this position in its statement issued in response to the signing into law of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which, among other things, removed hemp from the definition of "marihuana" (marijuana) in the Controlled Substances Act (CSA), thus taking it out of Schedule I.
Significantly, FDA is also considering an update to modernize its approach to new dietary ingredients (NDIs), including updating its compliance policy related to the same and developing guidance for preparing NDI notifications to ensure the Agency can thoroughly review the safety of these ingredients. At a public meeting this spring, FDA will address challenges that may act as barriers to supplement innovation and safety, including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients. Not discussed in the February 11th announcement was Commissioner Gottlieb’s indication in the post-Farm Bill statement that the Agency has authority to issue a regulation allowing the use of a pharmaceutical ingredient (e.g., CBD) in a food or dietary supplement, but that FDA would only consider doing so if all other requirements in the FD&C Act are met, including those required for food additives or NDIs.
Recognizing that the Agency must do more to leverage its existing resources and authorities to evaluate dietary supplements, Commissioner Gottlieb indicated in the announcement that FDA recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia, and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness.
Finally, the Agency plans to engage a public dialogue around whether additional steps to modernize the Dietary Supplement Health and Education Act (DSHEA) are necessary. One such step FDA is considering is having congress amend DSHEA to establish avenues for dietary supplement exclusivity and to add a product listing requirement. In the Agency’s view, a mandatory listing requirement could improve transparency in the marketplace, promote risk-based regulation, help facilitate efficient enforcement of the law, and establish new mechanisms to identify bad actors. While supplement exclusivity would be a boon to industry, product listing requirements would be burdensome.
State and Municipal CBD Enforcement
Despite the federal legality of hemp and hemp-derived CBD post-2018 Farm Bill, a number of states and municipalities are taking their cue from FDA when it comes to not allowing CBD in food and beverage products.
Two weeks ago, the New York City Department of Health (NYC DOH or the Department) ordered restaurants and bars to stop selling foods and drinks that contain CBD. NYC DOH noted that “Restaurants in New York City are not permitted to add anything to food or drink that is not approved as safe to eat…Until cannabidiol (CBD) is deemed safe as a food additive [by FDA], the Department is ordering restaurants not to offer products containing CBD.” Department inspectors reportedly embargoed CBD-containing products, meaning that bars and restaurants were asked to stop selling CBD-containing products, but that such products were not seized. Interestingly, in its frequently asked questions document on the state’s industrial hemp pilot program, the New York State Department of Agriculture and Markets indicates that a product that contains CBD as an ingredient can be sold in New York for human consumption if, among other things, the item is properly labeled and packaged for sale pursuant to FDA regulations for dietary supplements. As noted above, however, the Agency has taken the position that CBD is excluded from the FD&C Act’s definition of dietary supplement (i.e., CBD cannot, per FDA, be sold as a dietary supplement).
Earlier this month, the Maine Department of Health ordered stores to stop selling CBD edible products (e.g., foods, tinctures, and capsules), and the Ohio Department of Agriculture, in coordination with health departments and police agencies throughout the state, took similar action.
Despite the exploding CBD market, the increase in state and municipal enforcement in this space could have a chilling effect. Industry continues to wait with bated breath for FDA to clarify the rules of the road when it comes to adding the cannabinoid to food and beverage products. As discussed in our post on FDA’s reaction to the 2018 Farm Bill being signed into law, the Agency intends to hold a public meeting "in the near future" for stakeholders to share their experiences and challenges with products in this space, although a date and time for the same have not been set. Meanwhile, FDA continues to receive letters, from regulators and legislators, asking the Agency to review its position on hemp-derived CBD (e.g., letter from Vermont Secretary of Agriculture, Foods, and Markets, Anson Tebbetts, to FDA Commissioner Gottlieb; letter from Senators Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) to FDA Commissioner Gottlieb).
We are continuing to monitor developments in these areas, and will issue updates as appropriate. In the meantime, if you have questions regarding an issue raised in this post, please contact the authors or the attorney at the firm with whom you are regularly in contact.