Regulatory
Increased FDA Scrutiny of Eye Care Category
By Alvin J. Lorman, AAHP Counsel The Food and Drug Administration (FDA) last week continued its heightened surveillance on ophthalmic drug products sold without FDA approval or without complying with…
Read MoreFTC Proposes Rule Against False or Misleading Consumer Reviews and Testimonials
By Alvin J. Lorman, AAHP Counsel The Federal Trade Commission (FTC) has announced that it is moving forward with a proposed Trade Regulation Rule that is intended to prevent fake,…
Read MoreA High-Level Comparison of Homeopathic Product Regulation in the US, EU, and Canada
Two members of the AAHP Board, Mark Land and Eric Foxman, attended a June meeting with members of similar organizations from the European Union (EU), the United Kingdom (UK), and…
Read MoreFDA Cracks Down on Testing for Glycerin Contaminants — Again
By Al Lorman, AAHP Counsel The Food and Drug Administration (FDA) has begun another campaign to protect consumers from products that contain glycerin potentially contaminated with diethylene glycol (DEG) or…
Read MoreFDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance
By Mark Land, M.S., RAC, AAHP President The Office of Compliance (OC) shields patients from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions. OC makes…
Read MoreFDA Office of Compliance Annual Report FY 2022
FDA’s Office of Compliance (OC) recently published its Annual Report for Fiscal Year 2022.1 The report was introduced by Director Jill Furman. Ms. Furman took over the director’s role in…
Read MoreWhat’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…
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