Three Decades of Engagement with FDA for Common Goals: 1980–2010
This article is part of a series on the history of AAHP that expands on information originally presented in AAHP’s 100th Anniversary Report.
Fueled by the natural movement in the 1970s, consumers rediscovered homeopathic medicines, which in turned attracted more manufacturers to enter the U.S. homeopathic market. European manufacturers joining Weleda (which had operated a retail pharmacy in New York City since 1931) included Heel’s founder who relocated and established operations in New Mexico in 1979; Boiron USA in 1983; and Similasan USA in 1987. Schwabe/DHU followed through Nature’s Way in 1992 and Nelson Bach in 1996. More active manufacturers resulted in more association activities such as launching AAHP’s “Compliance Through Education” events for industry members, which continue to this day.
In 1981, AAHP proposed to FDA criteria to categorize individual homeopathic products into either prescription drugs or over-the-counter drugs. The agency had been unevenly applying its categorization to imported homeopathic products verses domestically produced homeopathic products. This created problems for FDA, U.S. Customs, and manufacturers — a situation that needed a fair and even-handed resolution.
For five years, AAHP members worked together to address FDA’s concerns. Al Lorman was brought on as AAHP’s Legal Counsel to represent the industry during negotiations with FDA. This resulted in the regulatory framework that governed the marketing of homeopathic products for nearly 30 years: the 1988 Compliance Policy Guide 400.400, Conditions Under Which Homeopathic Drugs May be Marketed. This was a major victory for AAHP and significantly advanced the U.S. homeopathic market.
In the 1990s, the CPG 400.400 brought stability; manufacturers and retailers now felt safe investing in homeopathic products on a wider scale. This resulted in products jumping from health food stores with the then-niche natural shopper to the Food/Drug/Mass retail channel with a wider general audience of shoppers. With set government rules in place, retail barriers broken down, and demand for products building, the question became, “was the industry equipped to deliver?” AAHP turned its attention to educating manufacturers on quality issues to ensure public safety. At the same time, AAHP wrote and sponsored a Continuing Education Course for pharmacists.
In 1995, AAHP hosted a compliance roundtable for industry with FDA’s Edward Miracco, who was assigned by the agency to field questions about CPG 400.400. AAHP’s educational programs, now branded as “Compliance Through Education,” offered an efficient way for FDA to reach many manufacturers at once.
AAHP took full advantage of this decade-long pipeline into FDA created by Miracco, working on: drug listing complexities; the English names only requirement; an exemption from the Imprinting of homeopathic solid oral dosage forms; an exemption from Alcohol Content Limits; and a solution to BATF’s drawback issues. As an approachable liaison to the industry, Miracco formed an invaluable and successful relationship between FDA and the industry through AAHP. In turn, AAHP provided FDA with the industry-wide representation it required.
In the late 1990s a petition was filed with U.S. Customs Service (now the U.S. Customs and Border Protection). The petition argued that, although the starting material of a homeopathic product may be too dilute to test at that time, the sugar spheres used as the inactive substrate in homeopathic OTCs were different than sugar used as a sweetener. The Customs Service — much like BATF in the 1980s — asked for industry agreement on the point and AAHP assisted in verifying and speaking on behalf of the industry with an outcome that was favorable to all.
As the 21st century began, interest in natural products continued to grow. Increasing consumer demand enticed “Big Pharma” companies to purchase homeopathic product lines and smaller niche manufacturers. The association entered an era of widely diverse members: small and large, as well as companies solely dedicated to homeopathy and others with varying product lines.
A new era in adverse event reporting began in 2006. The reporting requirements applied to homeopathic products as well. From that point on, AAHP emphasized information to its membership on the importance of ensuring public safety through quality controls in production. Association activities throughout the 2000s included 13 educational events for the industry; conducting a market survey on size, sales, and product line distribution; and, contracting a survey of American Association of Poison Control Centers (AAPCC) on the safety of homeopathic drug products. Other successes as the association basked in the glow of its 75th anniversary; supporting AIH’s rededication of the Samuel Hahnemann Memorial; requesting an exemption for a stay of revocation of final product testing; and successfully reversing U.S. Customs Service’s classification of homeopathic drug products as “foods.”
This active era with much industry growth was followed by concerns. Read about the association’s next decade of accomplishments in our History of AAHP series.
This article is part of a series on the history of AAHP that expands on information originally presented in AAHP’s 100th Anniversary Report. The full series of articles includes sections on: