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…
A 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…
The 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…
Three 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…
Summary 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…
FTC 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.…
FDA 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,…
FTC 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…
Developments 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…
FDA 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…
AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.
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