Dietary Supplements

“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.

Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.

When FDA warned Agebox about selling iKids-Growth IGF-1 Support supplements as unapproved drugs, agency along with CDC had for around a month been investigating outbreak of infant botulism linked to ByHeart formula.

FDA Human Foods Program’s list notes Kennedy’s GRAS focus as first item in “Food Chemical Safety” category, saying the agency in 2026 “will publish a proposed regulation to require the submission to FDA of GRAS notices for all substances claimed to be GRAS.”

Lawsuit filed in District of Columba federal court alleges FDA violated the authoritative statement provisions of FD&C Act, Constitutional Avoidance Doctrine and First Amendment by rejecting ANH-USA’s petition to allow 114 science-based health claims sourced directly from federal agencies.

“We remain fully committed to the integrated growth strategy that has enabled us to deliver significant growth and value creation, over the better part of the past decade,” says CEO Shailesh Jejurikar as firm reports net sales up 1% in latest quarter.

Consumer health product industry regulatory experts discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

Industry trade group executives discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

CRN’s support, a pivot from qualified backing for the previous bill, came after the senator added language to relieve firms of some responsibility around providing all claims for their products to FDA to include public-facing list.

HHS Secretary Kennedy says 2025-2030 guidelines “return us to the basics” and further his “Make America Healthy Again” campaign. CSPI says update “should have been based on high-quality scientific evidence, not trends, industry interests, or shifting cultural ‘wellness’ narratives.”

FDA rejects petition asking for approval to use, as health claims for supplements, nutrient–disease statements drawn directly from government publications and public-facing materials produced by NIH, CDC and other federal health agencies.

FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.