- New Citizen Petition Asks FDA to Require Homeopathic Drugs to be Tested for Effectiveness or Include a Disclaimer
- September 21, 2011 | Author: Susan J. Matthees
- Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
The Center for Inquiry, a non-profit organization with a mission to “promote scientific inquiry,” recently submitted a Citizen Petition to FDA requesting that the Agency initiate rulemaking for a proposed rule that would require all homeopathic drugs to be tested for effectiveness and, until the drugs are tested, require all advertisements for the products carry to state “WARNING: The FDA has not determined that this product is safe, effective, and not misbranded for its intended use.”
FDC Act § 505 prohibits a new drug from being introduced into interstate commerce without an application approved by FDA based, in pertinent part, on substantial evidence of effectiveness. Although homeopathic drugs are not exempt from FDC Act § 505, most are marketed under FDA’s Compliance Policy Guide (“CPG”) “Conditions Under Which Homeopathic Drugs May be Marketed” and are not approved by FDA. Pursuant to the CPG, marketed homeopathic drugs must meet the standards for strength, quality, and purity set forth in the Homeopathic Pharmacopeia of the United States, must have indications included in a Materia Medica, and must be labeled in accordance with the FDC Act and FDA’s regulations.
The Center for Inquiry does not explicitly ask FDA to revoke the CPG, remove homeopathic drugs from the market, or approve homeopathic drugs; the only explicit requests are that FDA use its authority to require efficacy testing for homeopathic drugs and a warning label for homeopathic drugs that are not tested. The petition is short on legal analysis, and instead is dedicated to explaining that scientific evidence demonstrates that homeopathic drugs are not effective. In particular, the Center for Inquiry mentions a product manufactured by Boiron as a product that allegedly has no credible scientific evidence of effectiveness. As you may recall, a federal court in California recently decided to allow a case against Boiron to proceed. The plaintiffs in that case allege that Boiron violated the California Legal Remedies Act and the California Unfair Competition Law and committed common law fraud by marketing homeopathic drugs that are not effective. The Center for Inquiry does not mention the California case.