Should the Dietary Supplement Industry Support FDA’s Push for Mandatory Product Listing?
Mandatory Product Listing
For those of us who have been around a while, it seems hard to believe that the Dietary Supplement Health and Education Act (DSHEA) just turned 27 years old. Unlike some laws, DSHEA seems to have aged well. The development of an ever-increasing multi-billion-dollar dietary supplement industry that has created incredible new ingredients and products that have benefited the health of the American public can be directly traced to its adoption.
We have seen FDA (U.S. Food and Drug Administration) issue final labeling regulations in 1997 that created and standardized Supplement Fact boxes; final regulations for statements of nutritional support (also known as “structure/function claims”) in 2000 that greatly expanded the scope of information that could be communicated to customers; and good manufacturing regulations in 2007 that provide for documented evidence that products are manufactured to a level of quality by design and quality systems to ensure product quality, strength, purity and identity. Mainstream industry has embraced the implementation of these regulations with little controversy.
The only significant statutory amendment specific to DSHEA, in December 2006, also with almost universal industry support, was the requirement to maintain records of adverse events and to report serious adverse events to the FDA. With few reports of serious adverse events, this amendment continues to demonstrate the record of safety enjoyed by the dietary supplement industry.
The industry now finds itself at a crossroad. There has been talk of creating a “DSHEA 2.0,” the centerpiece of which would be a “mandatory product listing” of all dietary supplement products that would involve mandatory submissions of information to FDA. Speaking at the Dietary Supplements Regulatory Summit in July 2021, Cara Welch, who was, at the time, the acting director of FDA’s Office of Dietary Supplement Programs (ODSP), spoke in favor of mandatory product listing, indicating that it would be valuable in terms of seeing how ingredients are used and helping the agency to allot inspectional resources. Theoretically, this would increase FDA’s ability to quickly undertake enforcement actions against non-compliant products. There are media reports that the office of Senator Dick Durbin (D-IL), who has generally not been supportive of the industry, is working on draft legislation to require mandatory listing of dietary supplement products with FDA.
The trade associations appear to be split on the question of mandatory product listing with CRN (The Council for Responsible Nutrition) “strongly” supporting the creation of a mandatory product listing1 and David Spangler, senior vice president of the Consumer Healthcare Products Association (CHPA), speaking in favor of it during a recent video blog. Daniel Fabricant, CEO and president of the Natural Products Association (NPA) has raised questions about the utility of such a list, arguing that enforcement of current laws should be the priority, while the American Herbal Products Association (AHPA) announced on Oct. 6, 2021, that opposition to mandatory product listing outweighs support in an AHPA member survey.2
Supporters of mandatory product listing argue that it would help FDA to know what is on the market, that failure to list could be an automatic prohibited act giving FDA an efficient enforcement mechanism, that retailers and consumers will look to the list as authoritative in making purchasing decisions and that its existence will serve to reduce the number of products with prohibited claims or ingredients that are currently on the market. All these goals, while well intentioned, are not likely to be solved or even significantly addressed by the creation of a mandatory product list.
First, one must ask what tools currently exist within DSHEA and are they being used by the agency to their full advantage. Section 403(r)(6)(C) of the Federal Food Drug and Cosmetic Act (21 U.S. Code § 343(r)(6)(C)) concerning misbranded food, states in addressing the requirements to make structure/function statements:
If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.
As promulgated by the agency in 21 CFR 101.93, this notification must include the name and address of the manufacturer, packer or distributor of the dietary supplement that bears the statement; the text of the statement that is being made; the name of the dietary ingredient or supplement that is the subject of the statement, and the name of the dietary supplement (including brand name).
Anyone who has taken any time to look at product labels knows that the vast majority of dietary supplement products use structure/function statements and would be subject to this notification requirement. Thus, FDA should already have a massive database of information concerning ingredients, products, claims and companies, yet FDA has never stated what they do with it or why it cannot be used as an enforcement tool. It also seems that FDA has rarely, if ever, cited a company for failing to submit the required notification. The only activity that seemingly takes place with the notifications sent to FDA is for FDA to send a “courtesy letter” if it questions the submitted claims. And, even when a courtesy letter is issued, there is little evidence to suggest that FDA follows up to ensure that changes are made to the claims. Why was this requirement incorporated into DSHEA if it was never to be used by FDA and should compliant companies be asking why is the agency seeking to increase the amount of time and money companies must spend in making submissions to the agency when complying with this existing requirement seems to be a total waste of time? If FDA has failed to utilize the information already in its possession from structure/function notifications, why would anyone expect anything different from a mandatory product list? It seems reasonable to ask what FDA is doing with this information before it asks Congress to mandate what will be mostly duplicative information.
Further, all facilities engaged in the manufacturing, processing, packing, or holding of dietary supplements for consumption in the United States must be registered with FDA, and all such facilities are subject to FDA inspection at any time, regardless of the owner or operator’s compliance with this registration requirement. During inspections, FDA may obtain all product labels, manufacturing records and interstate commerce shipment records.
Second, what will the penalty be for failure comply with mandatory product listing? Will the enforcement penalty be different for products that contain ingredients that are known to be an issue with FDA, such as those that are included on the Dietary Supplement Ingredient Advisory List,3 e.g., 1,4-DMAA, Higenamine or Sibutramine? Or will all failure be treated the same? What will be the penalty for otherwise compliant companies with hundreds of products that inadvertently fail to make a few submissions?
The argument is that failure to comply will be an “automatic” prohibited act, so FDA can enforce with little to no effort. Failure to submit a structure/function notification as currently required by law causes a product to be misbranded. Introduction of a misbranded product into interstate commerce is a prohibited act. If FDA has failed to enforce this prohibited act, why would anyone expect FDA to enforce against a newly created notification requirement? It is also fair to ask what would be the consequences of a newly created “automatic” prohibited act and what will the penalty be? A warning, simple fine, product seizure or a complete suspension of further sales? Will FDA be able to seize product or enjoin a company’s sales for the mere failure to submit information? Or will a company be able to “cure” by simply submitting the missing information? Also, will FDA be required to obtain judicial intervention (file evidence with a U.S. Federal Court) or act independently? It seems extraordinary if the agency were permitted to enforce any type of harsh penalty without first alleging and establishing a further violation of the Food and Drug Act in federal court beyond the mere failure to submit to stop the sale of a product?
Moreover, what will be the mechanism for FDA to verify that any submitted information is accurate and complete? If a person or a company is willing to market a product “spiked” with undisclosed ingredients, it seems highly unlikely that they will inform FDA in a submission. Therefore this seems like a potentially massive burden on compliant companies while the companies to be “exposed” by mandatory product listing are most likely to continue to remain “in the shadows.”
Third, is the argument that a mandatory product listing will serve as an “authoritative” listing upon which retailers and consumers will be able to rely. Labels might even be required to bear registration numbers. But how will that work?
Will the FDA review each listing at the time of submission to ensure that each product is compliant? If so, this certainly smacks of agency preapproval of dietary supplements, something that would certainly upset the “balance” of FDA’s authority created by DSHEA. A few of us may remember that DHSEA was unanimously enacted by Congress, in part, because FDA had tried to argue that dietary supplements were subject to agency preapproval as food additives but lost in federal court. See U.S. v. Two Plastic Drums, 984 F.2d 814 (7th Circuit 1993) and U.S. v. 29 Cartons, 987 F.2d 33 (1st Cir. 1993). Industry should oppose any scenario that serves to give FDA even the appearance of authority to preapprove dietary supplements. Note that the structure/function notification currently required by DSHEA was purposely crafted in the law to be required to be submitted to FDA “no later than 30 days after the first marketing of the dietary supplement” and not before marketing to ensure that it could not be interpreted as preapproval.
If there is no “preapproval” or automatic review at the time of submission, and the agency simply accepts all filings for the mandatory product listing, then how can inclusion on such a list be considered authoritative? Along these same lines, FDA has expressly stated that “it is currently illegal to market cannabidiol (CBD) by adding it to a food or labeling it as a dietary supplement” and that “CBD has the potential to harm you, and harm can happen even before you become aware of it.4” Will FDA accept mandatory product listings for CBD products, or will the agency be able to refuse submission making any sales automatically a prohibited act?
What about N-acetyle-L-cysteine (NAC), an ingredient currently in hundreds of products? In July of 2020, FDA sent warning letters to two companies stating, among other things, that NAC cannot be lawfully marketed as a dietary supplement because it was investigated as a drug before it was marketed as a dietary supplement. Despite the warning letters, many companies are continuing to market products containing NAC until the agency takes final action. With a mandatory product listing, will the agency be able penalize an otherwise compliant company or even remove its products from the market with the ease of flipping a switch? Again, are we that ready to risk the current structure and balance created by DSHEA that has worked so well over the past 27 years?
It seems that FDA has made little effort to use all the enforcement tools currently in its arsenal and is instead seeking new power that could upset the current balance created by DSHEA. Instead of additional funding for mandatory product listing, why not additional funding for enforcement with real “teeth?” Industry critics argue that FDA is ineffective because it issues warning letter with little or no follow-up. It is difficult not to agree. For example, in April 2019, FDA issued a series of warning letters on dietary supplements containing DMHA and phenibut.5 Critics of DSHEA have argued that the issuing warning letters was insufficient because products containing DHMA and phenibut remain on the market. If that is the case, what will the mandatory product listing accomplish? Do its advocates believe that companies that continue to market DMHA and phenibut are going to make mandatory product listing submissions? Will these companies that have ignored FDA warning letters because they have no fear of actual enforcement beyond a letter suddenly decide to stop marketing their products because a new mandatory product listing? It seems that after issuing a series of warning letters and alerting the public and industry that DMHA and phenibut are violative of the law, a real solution to the problem would be to have future violators face injunctive or perhaps criminal penalties.
Similarly, companies invest substantial resources in developing new dietary ingredients and complying with the law by filing new dietary ingredient (NDI) notifications only to be knocked off by potentially unsafe knockoffs that flout the notification process. Many of these knockoff ingredients are imported into the U.S. FDA can stem the flow of potentially unsafe knockoffs that have not filed NDI notifications by simply issuing an import alert at the border where FDA has its greatest authority. It would be a simple matter for compliant products to be released from import alert by submitting evidence of compliance by the law, but FDA refuses to act despite repeated requests from industry.
Given the failure of FDA to remotely come close to utilizing its existing enforcement powers, the question that must be answered is “does industry really want to support opening the law that has allowed for over a quarter-century of uninterrupted growth to solve a “problem” that FDA has not seriously attempted to address under the law as currently written.” To put it another way: Is the real problem that FDA has undercut its enforcement authority by repeatedly failing to follow up on a variety of high-profile warning letters (CBD, phenibut, GMP failures) or that FDA lacks some kind of authority that a product registry can magically address? NIE
References:
1 www.crnusa.org/Top-10-for-2021/advance-mandatory-prooduct-listing.
2 www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/1728/Opposition-to-mandatory-product-listing-outweighs-support-in-AHPA-member-survey.aspx.
3 www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list.
4 www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis.
5 www.fda.gov/food/cfsan-constituent-updates/fda-acts-dietary-supplements-containing-dmha-and-phenibut.
Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.
