Government Relations Committee

FDA has released a draft guidance outlining a proposed policy of enforcement discretion regarding the late submission of new dietary ingredient (NDI) notifications. Upon the release of a finalized guidance, companies will be able to electronically submit late NDIs to FDA for a set period (currently 180 days in the draft guidance) without penalty.

The American Herbal Products Association (AHPA) has estimated the dietary supplement industry will need to spend nearly 20 million dollars for initial compliance with the Dietary Supplement Listing Act, a bill introduced by Senators Richard Durbin (D-IL) and Mike Braun (R-IN) that would establish a requirement for mandatory product listing (MPL) for all dietary supplements marketed in the United States.

The United States Senate Committee on Health, Education, Labor and Pensions (HELP) has released a “discussion draft” of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, a piece of must-pass legislation that reauthorizes drug and medical device user fee programs.

The American Herbal Products Association (AHPA) is announcing opposition to the Dietary Supplement Listing Act introduced by Senators Richard Durbin (D-IL) and Mike Braun (R-IN) that would establish a requirement for mandatory product listing (MPL) for all dietary supplements marketed in the United States.

In the most recent episode of “Short Legal Briefs,” AHPA President Michael McGuffin joined host Josh Long and fellow industry trade association leaders to discuss mandatory product listing (MPL), N-acetyl-L-cysteine (NAC), and modernizing dietary supplement regulations.

The American Herbal Products Association (AHPA) has contacted the U.S. Trade Representative requesting the removal of punitive tariffs from a range of products relevant to the herbal products industry.

The U.S. Food and Drug Administration (FDA) has decommissioned an inaccurately titled repository of references following several years of requests by the American Herbal Products Association (AHPA) for the agency to address confusion created by this FDA product.

The United States District Court for the Southern District of New York last week entered summary judgment in favor of the United States Food and Drug Administration (FDA) in a suit filed in 2017 that sought to overturn FDA’s allowance for the GRAS self-affirmation process commonly used to document the safety of new food ingredients.

The Food and Drug Administration (FDA) has called on the U.S. Congress to pass legislation that would require mandatory product listing (MPL) for all dietary supplements in the United States.

On September 1, 2021, AHPA submitted comments to the Senate sponsoring offices for the “Cannabis Administration and Opportunity Act” (CAOA) Discussion Draft.