USA: Dietary supplement ingredient advisory list

17/05/2022 / infoAlimentario

The U.S. Food and Drug Administration removed 5-alpha-hydroxy-laxogenin and octopamine from the Dietary Supplement Ingredient Advisory List because, based on available information, the ingredients fall into one of the three categories described:

The ingredient appears to be excluded from use in a dietary supplement;
The ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use; or
The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied.

Although this list reflects ingredients for which the FDA has made a preliminary assessment, it is not an exhaustive list of ingredients that may or may not be lawfully included in dietary supplements. Ingredients may be added to or removed from this list as the FDA continues its evaluation.

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The Americas – USA: Draft Guidance for Industry: Policy Regarding N-acetyl-L-cysteine

26/04/2022 / infoAlimentario

The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of our intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled as dietary supplements. As described below, the enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

For further information, you can access the original source

The Americas – USA: FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol

26/03/202227/03/2022 / infoAlimentario

The U.S. Food and Drug Administration is issuing a 30-day procedural notice on the preliminary quantitative consumer research it plans to conduct on voluntary symbols that could be used in the future to convey the nutrient content claim “healthy.

The update to the definition and study of a potential symbol for the “healthy” nutrient content claim are part of the FDA’s broader efforts to help reduce the burden of diet-related chronic diseases and advance health equity. Updating labeling and making it more accessible helps empower consumers.

For further information, you can access the original source

The Americas – USA: FDA opened the application portal to participate in the Food Analysis Laboratory Accreditation program – LAAF

20/02/2022 / infoAlimentario

The U.S. Food and Drug Administration (FDA) opened the application portal for accreditation bodies interested in participating in the Laboratory Accreditation for Analyses of Foods (LAAF) program.

Under the LAAF program, the FDA will recognize accreditation bodies that will accredit food testing laboratories to standards established in the final rule on Laboratory Accreditation for Analyses of Foods (referred to as LAAF-accredited laboratories).

The final rule, issued by the FDA on December 3, 2021, established the LAAF program and outlined eligibility requirements that accreditation bodies and laboratories wishing to participate in the program will need to satisfy. The final rule also describes the procedures for how the FDA will manage and oversee the program. The FDA will maintain an online public registry of recognized accredited bodies and LAAF-accredited laboratories.