Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block became law. For those who may be new to this area, DSHEA is the law that defined "dietary supplements" as a subset of "food" under the federal Food Drug and Cosmetic Act. DSHEA also created categories of dietary ingredients, i.e., "old" and "new," and authorized the Food and Drug Administration (FDA) to regulate dietary supplements, in part by establishing good manufacturing practices, codified in 21 C.F.R. §§ 111, et seq. Simply put, the reason that we have a product category called "dietary supplement" is because of the framework established by DSHEA and FDA's implementing regulations.

Panelists expressed gratitude for how well DSHEA has operated to support the industry but also expressed concern about whether the law needs to be updated to keep pace with consumer demands, technology, and the differences in advertising today versus three decades ago.

Here are six key takeaways:

• Consumers are more informed. By laying the groundwork for the dietary supplement industry, DSHEA also created a pathway for broader advertising and more informed consumers. As one speaker noted, "no one knew what gingko was in 1994" and now it's easily found at every mass retailer and online.
• Changes in advertising add to the compliance challenges. Influencer marketing and self-care messaging have been powerful tools in reaching consumers over social media platforms that were not even contemplated when DSHEA was passed, creating an entirely "different marketplace with new, innovative ingredients, claims, marketing tactics, and an environment that evolves in days, not years," to quote one speaker. Many panelists expressed concern about the difficulty in managing the limitations on claims, both from a substantiation and structure-function compliance standpoint. Panelists also expressed concern that the FDA and the Federal Trade Commission (FTC) have been resistant to allowing industry to feature claims that address clinical research and innovation because of existing structure-function limitations and the FTC's evolving standards for "competent and reliable scientific evidence."
• There is no consensus on how to improve enforcement. Panelists discussed the perceived lack of enforcement by the FDA and FTC on "bad actors" but did not agree on whether the solution would be to clarify or increase regulatory jurisdiction, increase involvement by other enforcers such as state attorneys general, or implement a broader self-regulatory program. As many readers may know, the National Advertising Division (NAD), an advertising self-regulatory body, regularly considers dietary supplement cases and provides multiple avenues for companies seeking to help ensure a compliant marketplace.
• Contract manufacturers may get more scrutiny. Focusing on product compliance, Dr. Cara Welch, FDA's director of the Office of Dietary Supplement Programs, noted that her office believes inspection and scrutiny of contract manufacturers' compliance is an efficient investment because contract manufacturers regularly produce products for several brands. The agency's challenge, Welch noted, is that FDA does not currently have pre-inspection transparency into which contract manufacturers produce which products. A mandatory product listing is one way to achieve such transparency, but …
• Mandatory product listing (MPL) isn't universally favored or opposed. Building on the potential for contract manufacturers as an avenue for evaluating compliance across brands, the potential use of MPL to achieve such transparency was met with mixed reaction. Welch favored it as a means of more easily identifying the party ultimately responsible for a product and giving the agency a full view of the market. Others noted that MPL would also drive public trust. Industry representatives countered that MPL details must be considered, including whether failing to submit materials to the MPL registry would render a product misbranded or ineligible for import or export. Industry also noted the need for a single regulator to help address recent state legislative efforts to restrict sales of certain products to persons under age 18, suggesting that to get industry on board with MPL, express preemption of state sale and labeling laws must be up for discussion. In short, if industry is going to broadly agree to submit to MPL, then there must be greater legal benefit and protection in it for them.
• Would DSHEA be possible today? DSHEA was built on legislative compromise. Multiple speakers expressed concern that this kind of compromise probably isn't likely in today's highly partisan political climate and because industry champions from the past are no longer in office.

Despite varying opinions on how best to tackle these challenges, there was optimism that Congress may be open to creating a new framework for functional foods, which would broaden allowable claims, and accept that their risk profile is greater than that of conventional foods or supplements. This optimism was based largely on FDA's position that there is no current pathway for cannabidiol (CBD) and that a new structure is necessary. A new program specific to CBD would be economically inefficient, but if a new program included other functional products, it could bode well for the future of the industry.