As the result of the American Association of Homeopathic Pharmacists’ (AAHP) first grassroots effort, 38,000 letters from consumers and health care providers poured into offices of U.S. senators and representatives this spring. The letter-writing campaign urged Congressional leaders to ask the U.S. Food and Drug Administration (FDA) to incorporate key elements of the 1988 guidance regulating homeopathic products into the newly proposed guidance that FDA released last December.
The proposed guidance will help FDA pursue products that do not conform to the rules. While homeopathic manufacturers applaud FDA’s effort to ensure public safety, the industry believes that the new guidance is counterproductive because it does not provide clear labeling and manufacturing quality guidelines. Homeopathic manufacturers are asking FDA to include details from the 1988 guidance into the proposed new guidance, such as:
Definition of What Constitutes a Homeopathic Product
- A product that contains active ingredients listed in the Homeopathic Pharmacopeia of the United States
- A product that is supported by references that describe appropriate homeopathic uses
- A product with documentation to support active ingredients that are not recognized in the HPUS as being homeopathic
- Products that contain a combination of a homeopathic and non-homeopathic active ingredients are not considered homeopathic
For roughly six weeks, email alerts were sent to nearly 2.3 million consumers or health care providers through AAHP member companies’ databases, as well as through partners including the Alliance for Natural Health USA, American Institute of Homeopathy, National Center for Homeopathy, Organic Consumers Association, among other organizations. States that produced the most letters correlate with states with large population, but a couple states made the top 10 due to extra e-blasts targeting constituents of particular Congressional committees. The top 10 letter-writing states were: Pennsylvania (1,529 letters), Florida (1,413), Washington (1,321), California (1,265), Colorado (1,074), Texas (864), New York (616), Minnesota (557) Tennessee (557) and Arizona (487).
“The grassroots campaign allowed the homeopathic community to come together and give voice to our consumers,” said Mark Land, AAHP president. “Their message? They want safe and effective homeopathic medicines. AAHP’s proposed additions to FDA draft guidance will give manufacturers they clarity they need to do that.”
AAHP leaders and members also conducted 60 meetings on Capitol Hill since early January to encourage Congressional members to amplify the homeopathic community’s message to FDA. Congressional members were asked to co-sign one of two letters: one from the Senate sponsored by Sen. Orin Hatch of Utah, a longtime champion of alternative medicine; and the other from the House of Representatives, sponsored by Rep. Ryan Costello of Pennsylvania, which is the home state of four homeopathic manufacturers. This successful campaign yielded the support of five senators and 10 representatives!
The House of Representatives letter sponsored by Rep. Costello was co-signed by:
- Mike Coffman (Colorado’s 6th congressional district)
- John Curtis (Utah’s 3rd congressional district
- Brian Fitzpatrick (Pennsylvania’s 8th congressional district)
- Mike Gallagher (Wisconsin’s 6th congressional district)
- Jamie Herrera Beutler (Washington’s 3rd congressional district)
- Steve King (Iowa’s 4th congressional district)
- Mia Love (Utah’s 4th congressional district)
- Cathy McMorris Rodgers (Washington’s 5th district)
- Erik Paulsen (Minnesota’s 3rd congressional district)
The Senate letter sponsored by Sen. Hatch was co-signed by:
- John Boozman (Arkansas)
- Joni Ernst (Iowa)
- Martin Heinrich (New Mexico)
- Shelley Moore Capito (West Virginia)
The association also prepared its comments to the proposed guidance, which were submitted the by the May 20 deadline. All together this is the most significant effort undertaken by AAHP in the past decade.
For more information, visit www.aahp.info.