The U.S. Food and Drug Administration (FDA) has called for Congress to require mandatory product listing (MPL) for all dietary supplements in the U.S. marketplace. In its 2021 budget request, FDA stated that this concept would “require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products”. AHPA has received reports that MPL legislation may soon be proposed in the U.S. Congress. As the debate over MPL continues to develop, and as part of his “Short Legal Briefs” series, Informa Markets editor Josh Long has conducted a pair of interviews with major dietary supplement industry figures delving into the cases for and against MPL.
The case for MPL
In the first interview, David Spangler, Senior Vice President of the Consumer Healthcare Products Association, and Scott Bass, partner with Sidley Austin LLP and outside counsel to CHPA, argued that MPL would be a “win-win-win” for industry, FDA and the public. Among other issues, David Spangler observed that FDA already has access to relevant labeling information for many products from sources such as the National Institutes of Health Office of Dietary Supplements’ Dietary Supplement Label Database (DSLD). However, David noted that currently available sources are not authoritative or comprehensive, and lack an enforcement mechanism. David argued that unlike the DSLD, MPL would give FDA definitive visibility into the marketplace, allowing more efficient enforcement, and would be accompanied by a provision making it a prohibited act to fail to list a product. David believed that the “pretty bureaucratic” enforcement of a listing requirement would be the easiest, most efficient use of mislabeled supplements. Scott Bass added that MPL would enable “smarter enforcement”, and give the agency a tool to rapidly pursue products that fail to list- and that because compliance was mostly computer driven, additional costs for industry would be no more than a few full-time employees.
In response to arguments that some have made that FDA has failed to use its existing regulatory authority, Scott Bass asserted that MPL would let the agency know about the existence of thousands of potentially harmful products that they currently are not aware of, rather than enforcing on products that aren’t causing harm. Legislative authority for MPL could also be accompanied by additional enforcement funding. Additionally, Scott argued that if the label database were public, large retailers would choose not to purchase unlisted products, creating a form of secondary enforcement beyond FDA.
The case against MPL
In the following interview, Mitch Coven, CEO of Vitality Works, a private label manufacturer, Aaron Secrist, the executive VP of NOW Health Group, and Steven Shapiro, of counsel with Rivkin Radler LLP, presented a very different picture of the effects of MPL. Mitch Coven stated that at the outset, it wasn’t clear what the problem was: supplements are a very safe product category, and there is no similar requirement for listing high risk products in other fields, such as peanut butter, ice cream or meat. Responding to the belief that mandatory listing would increase industry compliance and root out bad actors, Steven Shapiro argued that bad actors would have little reason to comply with a listing requirement; they would simply fail to list or submit incorrect labels and pay any fines that occur as a cost of business. Mitch Coven observed that MPL would be much more expensive for legally compliant industry, estimating at least a six-digit cost in compliance and staffing for his company to maintain accurate, updated label listings with FDA. Private label or contract manufacturers would be forced to pass these costs on to their clients, including small businesses that subsist on tight margins.
Steven Shapiro pointed out that FDA has not followed up on existing enforcement authority that already targets noncompliant companies, such as by systematically following up on “courtesy letters” sent to companies that the agency believes are making inappropriate label claims, or by making greater use of import controls to address unapproved new dietary ingredients entering the country. Aaron Secrist noted that FDA has access to other stores of information that are currently underutilized, including adverse event reporting requirements that are more strenuous for dietary supplements than for higher-risk food products.
Both interviews, which go into further depth on the potential effects of MPL, are available from the Natural Products Insider website.