Regulatory/Legislation

Disclaimers in Advertising and Labeling: What Do They Do? Who Does What?

April 26, 2017

By Mark Land, AAHP President The FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. This is FTC’s way of saying disclaimers may cure potentially misleading claims in general or, in our case, homeopathic therapeutic claims specifically. Communicating information to consumers in the noisy marketplace…

United States Food and Drug Administration Office of Pharmaceutical Quality

April 26, 2017

By Mark Land, AAHP President May 1, 2017 The Office of Pharmaceutical Quality (OPQ), created in Jan. 2015, enhances the U.S. Food and Drug Administration Center for Drug Evaluation and Research’s (FDA CDER) Quality Initiative. It creates a drug quality program as robust as the programs the agency already has in place for drug safety…

FDA Office of Surveillance and Epidemiology

April 3, 2017

By Mark Land, AAHP President April 1, 2017 FDA’s Office of Surveillance and Epidemiology (OSE) is positioned within the Center for Drug Evaluation and Research (CDER). OSE evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of drugs. OSE maintains a system of…

Consumer Label Comprehension

March 3, 2017

By Mary Borneman, Sr. Director of Communications & Public Affairs, Hyland’s, Inc. March 1, 2017 It’s not news that the Internet and access to information has created what one could argue is the most knowledgeable consumer any business has ever had. From using crowdsourcing and reviews to determine the best electronic or household appliance to…

The FTC and the Web

February 28, 2017

By Alvin J. Lorman, Association Counsel March 1, 2017 The recent claim by the Federal Trade Commission (FTC) that its policy statement on marketing of homeopathic drugs applies to labels and labeling as well as advertising has caused many to ask about the legal boundaries of the FTC’s jurisdiction. When you think of the FTC,…

Congress to Tackle “Must Pass” FDA Legislation Next Year

January 26, 2017

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and DrugAdministration (FDA) to collect fees from Rx pharmaceutical companies to help fund the agency’s drug review work, hire FDA staff, and improve systems. The end goal of this user fee collection system is more timely approval of human drug applications. The regulated industry supports…

What About Your APIs and Q7 Requirements?

January 26, 2017

By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients—Guidance for Industry. The document applies to the manufacture of Active Pharmaceutical Ingredients (APIs) for use in human drug products and closely follows a…

Regulatory Policy Analysis

January 4, 2017

A Tool for Evaluating the  Regulatory Framework for Homeopathic Drug Products By Mark Land, AAHP President Today the combination of drug regulations, approval options, cost controls and societal health care goals yield outcomes that are no longer obvious or predictable. So complex is the process that the field of regulatory science emerged to address the…

Who Regulates Your Product Labels?

January 4, 2017

Does the U.S. Food and Drug Administration (FDA) regulate homeopathic product labels? Or does the U.S. Federal Trade Commission (FTC)? Is it both? While most members of the homeopathic industry have long understood that the FDA is responsible for over-the-counter (OTC) drug labels and labeling and the FTC is responsible for OTC drug advertising, the…

A Trump Administration and a Republican-Controlled Congress

January 4, 2017

An Assessment and Outlook of the Political and Regulatory Climate for 2017 By Pete Evich, AAHP government relations January 1, 2017 The election of Donald Trump and a Republican-controlled Congress will mark a change from the “divided government” norm that has reigned over Washington during the last six years. While the new political environment will…

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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