What happens if the Dietary Supplement Listing Act of 2022 passes? What if it doesn’t?

We recently published an article on the Dietary Supplement Act of 2022, and the potential dangers of supplements which led to the bill’s introduction. While the current lack of regulations have raised concerns with consumers and regulators alike, some say that that proposed bill would not achieve the intended effects. 

What does the Dietary Supplement Act of 2022 propose?

If the Dietary Supplement Act of 2022 passes it would form a mandatory product listing (MPL) system, in which the manufacturers and suppliers of dietary supplements would be required to submit certain product information to the FDA prior to it being sold on the market (Hekking & Guggenheim, 2022). 

This product information would include:

• The brand and proprietary name of the dietary supplement,
• An electronic copy of the dietary supplement label and any package insert,
• A list of all ingredients and the amount of each ingredient per serving,
• The conditions of use,
• The warnings and precautions,
• The presence of any major food allergens,
• The dosage form, and
• A list of health claims or structure/function claims.

The FDA would then take this information and create a database with unique identifying numbers for each product. This would easily enable consumers and regulators alike to gain transparency into the Dietary Supplement Industry. For instance, consumers would be able to determine which ingredients they are consuming and whether they have any adverse interactions, and the FDA could better enforce safety standards by having a list of which supplements are made by which companies. 

Any new ingredient would require another listing. This would also be the case if a manufacturer wanted or needed to use an alternative ingredient. For instance, “if Kellogg switched from, say, high-fructose corn syrup to sucrose in its Frosted Flakes” (Jacobowitz, 2022). 

The American Herbal Products Association (AHPA) estimated that the initial cost to the dietary supplement industry of complying with the new MPL requirements would be $20 million, noting that this “does not include associated training costs or other year-over-year costs of continuing compliance” (Grebow, 2022). On the government’s end, The Dietary Supplements Act of 2022 sets aside $4 million in the 2022 fiscal year to support the creation of the MPL database, and another $1 million every year after through 2026 ($8 million in total) (S. 4090 – 117th Congress, 2022). The AHPA’s Regulatory Affairs Director spoke to the MPL’s cost estimate, stating that it is an essential aspect to consider when deciding whether to support the proposed bill. This is particularly concerning to some others, after the last several years, as, between fires, droughts, and the COVID-19 pandemic there have been increasing need for companies to use alternative ingredients in their products, and the cost estimate does not include the maintenance of the database. 

This being said, dietary supplement databases actually already exist. For instance, the Supplement Online Wellness Library (OWL) was formed in 2017 by the Council for Responsible Nutrition. In fact, other critics of the bill argue that the bill would not be enacting enough change, as it would merely be duplicating a resource which already exists (McGuffin, 2022). For, while participation in Supplement OWL is voluntary, it currently contains product information for over 13,000 products, and is widely used by the FDA and National Institutes of Health to gain insight into the market (Supplement OWL, 2022; Hekking & Guggenheim, 2022).