DSHEA label disclaimer

    On December 11th, the U.S. Food and Drug Administration (FDA) released a letter to the Dietary Supplement industry confirming that it is considering amending 21 CFR 101.93(d) in response to several requests to change the current labelling regulation.

    As mandated by the Dietary Supplement Health and Education Act of 1994 (DSHEA), the disclaimer “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” must appear on every panel of the label where structure/function claims are made. However, the FDA has rarely, if ever, enforced this requirement. 

    The FDA will start the review of this request. If no major concerns are identified, the agency will propose a rule to amend this requirement. 

    No target dates were provided; however, the FDA acknowledges that formally amending the regulation will take time. In the meantime, the agency will exercise enforcement discretion regarding the “every panel” disclaimer requirement, providing immediate relief to industry from this obligation.

All Amazon sellers to undergo a third party Testing, Inspection and Certification for Dietary Supplements

    Amazon has initiated a new phased rollout for Dietary Supplements: all sellers on the platform must perform a third-party Testing, Inspection and Certification (TIC) from an accredited entity to confirm that their products are manufactured in facilities compliant with current Good Manufacturing Practices (cGMP).

    During this phased rollout, Amazon will reach out to companies, which will have 90 days to start a documentation request with a TIC provider. In cases where Amazon can verify cGMP compliance through third-party confirmations or public databases, outreach to companies may not be necessary.

    It is important to note that the cGMP requirement is in addition to and separate to the existing product testing requirements for already identified categories: sexual enhancement, weight management, bodybuilding, sports nutrition, and joint health products.

    In a separate initiative, Amazon has launched its Compliance Fast-Track program for certain Dietary Supplement products. This program allows Amazon to gather all required certified documentation directly from partner organisations. This means that companies using Compliance Fast-Track do not need to provide information directly to Amazon.

    At present, the organizations partnering with Amazon for the Compliance Fast-Track program are: BSCG, Clean Label Project, GRMA, INFORMED, NSF, and USP.