Consumer Label Comprehension

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 toContinue Reading

Disclosing Relationships with Influencers on Social Media

By Deborah Kelly, public relations manager, Boiron USA March 1, 2017 The core mission of the Federal Trade Commission (FTC) is to regulate advertising so businesses won’t mislead consumers or engage in deceptive practices that would affect behavior or decisions about a particular product or service. One area of particular concern and scrutiny is endorsements.Continue Reading

Outlook 2017

By Mark Land, AAHP President March 1, 2017 2017 is shaping up to be a year in motion—both for our industry and our country. With a new Administration and Congress, continued effects of 2016 statements and warnings from federal agencies, and even personnel transitions within these agencies, 2017 will be full of changes, for betterContinue Reading

The FTC and the Web

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,Continue Reading

Manufacturers of Homeopathic Medicines Review FDA Test Results and New Application of Technology

MILWAUKIE, Ore., Feb. 14, 2017 — The U.S. Food and Drug Administration (FDA) announced on Jan. 27 that its laboratory analysis found inconsistent levels of some specific constituents in certain homeopathic teething tablets. While the industry fully supports and shares the agency’s efforts to safeguard public health, the American Association of Homeopathic Pharmacists (AAHP) cautionsContinue Reading

AAHP in 2016 and a Review of New Member Resources

Jan. 26, 2017 In 2016, the Education Committee produced four robust webinars, and industry leaders united at two membership meetings. As we step forward into 2017, it’s a good moment to reflect on other highlights that brought value to the membership. Legal & Regulatory AAHP recently met with the Federal Trade Commission (FTC) regarding theContinue Reading

The Tale of the Contract Manufacturer: A Story Based on an AAHP Member Question

By Eric Foxman, AAHP Secretary Once upon a time, a special creature, the CIAMP (Company Interested in Alternative Medical Products), wanted Phoxman Farmaceuticals (PhoxFarm) to contract manufacture a product for it. Over cheesecake and ice cream, they discussed the project and agreed to do business together. The CIAMP created the formula, designed the labeling andContinue Reading

Congress to Tackle “Must Pass” FDA Legislation Next Year

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 supportsContinue Reading

What About Your APIs and Q7 Requirements?

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 aContinue Reading

The European Pharmacopeia and How U.S. Manufacturers Can Use It

By Mark S. Phillips, Pharm. D. Jan. 26, 2017 On Jan. 1, 2017, the 9th edition of the European Pharmacopoeia (Ph. Eur.) became legally binding in its 37 European member countries and the European Union. Compared to the 8th edition, more than 50 percent of the text is new or revised. The European Pharmacopoeia isContinue Reading