Supply Chain
Agency exercises enforcement discretion on requirement for products to be labeled as containing artificial colors or dyes when those aren’t native to foods or ingredients, including added colors made from natural sources.
In contributed commentary, Susan Levy, SBL Consulting Group founder and principal, discusses likely health and wellness market developments which would reflect a steady shift toward more accessible, consumer-centric models of care complementing traditional healthcare.
“Dietary Supplement Regulatory Uniformity Act” would prohibit states from adding requirements and rules for supplement manufacturing and sales on top of FDA regulations.
Hawaii proposes age-restricted sales but, unlike similar bills also filed in Alaska, Massachusetts, Michigan and Washington legislatures, would require behind-the-counter storage to limit consumer access in stores.
“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.
Wonderbelly reached market in 2022 and has notched nationwide footprint through major retailers over the years, Target stores starting in March 2023, CVS since June 2024 and Walmart since May 2025.
Lanreotide supply issues cloud Cipla’s Q3 FY26 earnings, with impact seen in Q4 as well, though pipeline assets augur well for US growth continuity. Perpetual rights to Novartis’s Galvus effective Jan 1, seen adding momentum to India diabetes gains.
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.”
Lanreotide supply issues cloud Cipla’s Q3 FY26 earnings, with impact seen in Q4 as well, though pipeline assets augur well for US growth continuity. Perpetual rights to Novartis’s Galvus effective Jan 1, seen adding momentum to India diabetes gains.
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.