Happy Friday! 

Dietary Ingredients Exempt from Global and Reciprocal Tariffs

Although some Global or Reciprocal Tariffs may be suspended for 90 days, certain Dietary Supplement ingredients have been declared exempt.

According to Annex II of the executive order that implemented these tariffs, the following dietary ingredients are exempt:

• Vitamin A
• Vitamins B1, B2, B5, B6, and B12
• Vitamin C
• Vitamin E
• Folate
• Niacin and Niacinamide
• CoQ10
• Choline
• Fatty Acids of animal and vegetable origin
• Calcium
• Barium
• Magnesium
• Iron
• Manganese
• Copper
• Zinc
• Chromium
• Silicon
• Selenium
• Otherwise unspecified minerals
• Lysine and unspecified amino acids and amino acid esters

FDA Opinion on New Dietary Ingredient (NDI)

The FDA has recently published its opinions on 10 NDI notifications, with only one application considered compliant: the herbal extract QishenYiqi (NDI 1335). The remaining applications were rejected due to:

• Incomplete dossiers;
• Safety concerns raised by the FDA;
• Failure to meet the legal definition of a Dietary Ingredient under 21 U.S.C. § 321(ff).

FDA instructed to assess the potential elimination of GRAS process

The FDA is expected to revise their Final Rule on Substances Generally Recognized as Safe (GRAS) and related guidance to eliminate the self-affirmed GRAS process.

Currently, the FDA strongly encourages manufacturers to submit GRAS notices through the agency’s GRAS Notification Program.  However, the industry has the option to self-affirm that a substance is GRAS, which allows them to skip notifying the FDA.

If the self-affirmation process is eliminated, companies looking to introduce new ingredients in food would be required to publicly notify the FDA in advance of their intended use of those ingredients and provide safety data.

This announcement did not include a specific timeline for evaluation or details on how the elimination process would take place. 

FDA plans to postpone to July 2028 the compliance date for Food Traceability

The FDA will delay the compliance date for its “Food Traceability Rule” from January 2026 to July 2028 (2.5 years). This change has yet to be formalized by notice and comment rulemaking.

The “Food Traceability Rule”:

• Establishes additional traceability record-keeping requirements beyond what is already required in existing regulations. 
• It will apply to persons who manufacture, process, pack, or hold foods on the “Food Traceability List”.
• Applies to domestic and foreign entities producing food for US consumption.

Restriction of sale of Dietary Supplements, including those containing creatine, to children and adolescents

The US Government agencies were attempting to restrict the sale of Dietary Supplements, including the ones containing creatine, to children and adolescents. 

In response, the International Society of Sports Nutrition (ISSN) issued a statement. The ISSN letter argued that the legislation restricting the sale of creatine-containing products to young people is not supported by scientific evidence, In fact, research strongly supports the importance of creatine in the diet and its safety as a supplement.

This is a developing narrative; we will update it as new information emerges.