Regulatory
What’s In a Name?
By Al Lorman, AAHP Counsel FDA’s issuance of its new guidance on homeopath drugs in December, 2022 has caused concern in some quarters because of the language used by the…
Read MoreA Retrospective Policy Analysis of FDA’s CPG 400.400
The origins of FDA’s CPG 400.400 go back to a series of meetings between industry and Agency enforcement personnel in the 1980s. The resulting CPG was unusual in that many…
Read MoreThe Regulation of Homeopathic Drug Products
Statutory Recognition of Homeopathic Drugs Since the passage of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938, homeopathic drugs are the only form of alternative or complementary medicine…
Read MoreThree Changes Proposed in 2024 Federal Budget that Could Affect Homeopathic Manufacturers
President Biden unveiled his 2024 Federal Budget Proposal on March 9, 2023. AAHP is highlighting three items that could impact homeopathic manufacturers. These items are among a variety of legislative…
Read MoreSummary of FDA’s “Report on the State of Pharmaceutical Quality: Fiscal year 2021”
By Mark Land, M.S., RAC, AAHP President Introduction In August of 2022, the United States Food and Drug Administration (FDA) published its fourth annual Report on the State of Pharmaceutical…
Read MoreFTC Updates Health Claims Substantiation Guidance
By Alvin J. Lorman, AAHP Legal Counsel The Federal Trade Commission last month released a lengthy guidance document on the substantiation it expects for health claims, Health Products Compliance Guidance.…
Read MoreFDA Finalizes Homeopathic Guidance
By Alissa Gould, AAHP Communications Chair Seven years after the U.S. Food and Drug Administration (FDA) held a public hearing on homeopathic product regulation and two rounds of public comments,…
Read MoreFTC Proposes Making Rules Affecting Endorsements and Testimonials
By Alvin Lorman, AAHP Counsel Calling fake and deceptive product reviews and endorsements “problematic” and its remedial authority “limited,” the Federal Trade Commission (FTC) has taken the first step toward…
Read MoreDevelopments on Capitol Hill of Interest for AAHP Members
Senate Leadership of Key Committees Overseeing FDA/FTC Will See Changes in Next Congress Leaders of Influential House Committee to Remain but Role Reversal Predicted By Pete Evich, Vice President, Van…
Read MoreFDA Warning Letters for Skin Tag and Mole Removal OTCs
By Alvin Lorman, AAHP Counsel The Food and Drug Administration (FDA) has reminded two OTC drug manufacturers that mole and skin tag removal are prescription-only indications. The agency issued Warning…
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