Regulatory/Legislation

FDA Guidance Document Development Process 

January 23, 2024

By Alvin J. Lorman, AAHP Counsel The Food and Drug Administration (FDA) is seeking public comment on a draft “Report and Plan on Best Practices for Guidance.” Guidance documents, rather…

118th Congress: Legislative Productivity Stymied by Partisan Divide

November 15, 2023

The 2022 midterm election resulted in putting Republicans in control of the House of Representatives by the narrowest of margins (222 to 213). With the Democrats succeeding in maintaining control…

The History and Future of Regulations for Homeopathy

November 14, 2023

The principal federal regulators of the manufacture, sale, and marketing of homeopathic drug products are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Both agencies recognize…

Increased FDA Scrutiny of Eye Care Category 

September 18, 2023

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…

FTC Proposes Rule Against False or Misleading Consumer Reviews and Testimonials

August 22, 2023

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,…

A High-Level Comparison of Homeopathic Product Regulation in the US, EU, and Canada

July 19, 2023

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FDA Cracks Down on Testing for Glycerin Contaminants — Again

June 13, 2023

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…

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance

June 13, 2023

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…

FDA Office of Compliance Annual Report FY 2022

June 7, 2023

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…

What’s In a Name?

April 19, 2023

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…

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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