A bill before U.S. Congress proposes a new requirement that all dietary supplement products be electronically listed with Secretary of Health and Human Services. This move will enable the creation of a publicly available on-line registry in support of consumer decision making and to provide FDA better oversight of dietary supplement products sold in the U.S. market. The bill is commonly known as the Dietary Supplement Listing Act of 2022.
If passed, it would amend Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) with the insertion of dietary supplement listing requirements in 403D, after section 403C.
Historically, the dietary supplement industry has operated under the U.S. federal requirements of current Good Manufacturing Practices (cGMPs) (11 CFR 111) and labeling (21 CFR 101) but has avoided the additional requirements placed up on the Rx and OTC pharmaceutical industry of listing products.
The passage of this bill would be a major undertaking and shift with tens of thousands of products and companies affected. Each dietary supplement product would be required to conform to the additional listing requirements or be considered to be misbranded. “Responsible parties” would be formally designated as a front-line communication between the company and the federal government. That responsible person may be an employee of the firm directly or a third-party (such as EAS) if the firm is domestic. Foreign entities selling supplement products in the U.S. must always utilize a U.S. Agent as their responsible party, (EAS also provides U.S. Agent services).
As part of the Listing Act, dietary supplement manufacturers must obtain and utilize a Unique Listing Identification Number (ULIN) to be included in the electronic listing as well as display this ULIN on product labels. A ULIN enables identification of the product not only for listing purposes but to expeditiously identify products in the event of an adverse event or recall.
If passed, required information as part of the Dietary Supplement Listing Act of 2022 will include:
- proprietary name of the product
- statement of identity
- full name and contact information for the responsible person
- full name and contact information of the owner, operator, or agent in charge
- full name and contact information for U.S. Agent
- identification of manufacturing, packaging, labeling and/or holding locations
- electronic copy of the product label
- electronic copy of any package insert
- list of all ingredients
- number of servings per container for each container size
- conditions of use
- warnings and precautions including major food allergens
- dosage form
- marketing claims
- unique dietary supplement identifier
There are also requirements applicable to some but not all products such as amount of nutrients per serving and daily values of nutrients.
If you haven’t conducted a review of your product labels in a while, consider doing so. EAS offers resources such as a supplement labeling handbook and type size guides so that this review can be conducted in-house. We offer comprehensive label reviews, in-house training programs where our experts not only educate your labeling team but utilize your company labels as part of the exercises. We also offer public labeling trainings, the next being offered October 24, 26 and 28, 2022. More information on the specifics of these services can be found in the hyperlinks and on the EAS website.
Whether or not the Dietary Supplement Listing Act of 2022 passes, the exercise of reviewing product labels, perhaps even revisiting specifications, validation and verification can go a long way to continuing to provide safe products to the consumer.
Contact EAS to understand the proposed Dietary Supplement Listing Act of 2022 and how your company should prepare.
Posted in Dietary Supplements, Issue of the Month.