Page 4 - Kattison Avenue Newsletter - Spring 2026 - Issue 16

FDA Enforcement, MAHA and the Expanding Scrutiny of Health and Ingredient Claims

Evolving Food and Drug Administration (FDA) enforcement priorities and broader political attention on food, wellness and ingredient
transparency are reshaping advertising risk across multiple industries.
• Compounded GLP-1 products remain under significant
scrutiny: The compounded GLP-1 market expanded rapidly
during federal drug shortages that temporarily permitted
503A and 503B compounding pharmacies to produce versions
of branded drugs despite exclusivity protections. After the
FDA determined in October 2024 and February 2025 that
shortages of tirzepatide and semaglutide, respectively, had
resolved, many companies continued marketing compounded
products, with some pivoting to “salt forms” (e.g., semaglutide
sodium) or adding vitamin B-12 to invoke patient-specific
exceptions. The FDA’s April 2026 guidance rejected these
workarounds, imposing a four-prescription monthly limit
for essential copies, eliminating the personalized-products
loophole and clarifying that cost is not a recognized clinical
need for compounding.
• Weight-loss supplement and wellness product claims
present heightened risk: The FDA is actively scrutinizing
supplements and wellness products that attempt to capitalize
on consumer demand for GLP-1 drugs through claims that
products “work like Ozempic,” or “activate” or “support”
the body’s natural GLP-1 response. The FDA views these
types of representations as implied disease or drug claims
that may cause products marketed as supplements to be
regulated as unapproved drugs. Careful claim substantiation
and marketing review are critical in this area, and advertisers
were cautioned that a supplement may be classified as an
FDA-regulated drug based on the product’s claimed intended
use as expressed through labeling and advertising.
• MAHA is increasing pressure on food additives and
ingredient disclosures: The “Make America Healthy Again”
initiative is creating significant political and regulatory
pressure for the FDA to take a more aggressive approach
to food additives and ultra-processed foods. The FDA has
increasingly relied on the Delaney Clause as a basis for action
against additives linked to cancer risk, including revoking
authorization for Red Dye No. 3, removing brominated
vegetable oil from approved use, and initiating proceedings
involving Citrus Red No. 2 and Orange B. HHS Secretary
Robert F. Kennedy Jr. has further directed the FDA to explore
reforms to the self-determined Generally Recognized as
Safe (GRAS) process, which could meaningfully expand FDA
oversight by requiring manufacturers to submit ingredient
safety determinations for agency review.

4 Kattison Avenue | Spring 2026