California Court Allows Case Against Homeopathic Drug Manufacturer to ProceedAugust 9, 2011
By Susan J. Matthees –
Apparently as a result of a misunderstanding of the basic principles of homeopathy, and how of necessity the efficacy testing for such drugs differs from non-homeopathic drugs, a judge in the U.S. District Court for the Central District of California recently decided that claims against a manufacturer of a homeopathic drug are not preempted by the Federal Food, Drug, and Cosmetic Act (“FDC Act”). The plaintiff in the case, Delarosa v. Boiron, Inc., alleged that Boiron violated the California Legal Remedies Act and the California Unfair Competition Law and committed common law fraud by claiming that its homeopathic product, Children’s Coldcalm, would provide relief from symptoms of a cold. Boiron filed a Motion for Judgment on the Pleadings, arguing that the plaintiff’s claims were preempted by the FDC Act. The court denied Boiron’s motion, concluding that the FDC Act did not preempt challenges to homeopathic products.
Homeopathic drugs have a unique status under the FDC Act. FDC Act § 201(g)(1) defines “drug” to include articles recognized in the official Homeopathic Pharmacopeia of the United States (“HPUS”) or National Formulary (“NF”). But, unlike other drugs, FDA does not evaluate homeopathic drugs for safety or efficacy prior to marketing, has not created any monographs under which an OTC homeopathic drug might be marketed, and does not impose standards for strength, purity, or quality of homeopathic drugs. Instead, homeopathic drugs must meet the standards of strength, quality, and purity set forth in the HPUS. Further, product claims are subject to the FDC Act’s misbranding provisions, and therefore claims for the drugs must be truthful and not misleading. Manufacturers of homeopathic drugs must follow labeling provisions in FDC Act sections 502 and 503 and 21 C.F.R. Part 201, register with FDA, and comply with GMP requirements. FDA has taken action against homeopathic products that may be unsafe, but the court noted that it could find no record of any investigation of homeopathic remedies due to a reported lack of efficacy. We note that the FTC has brought actions against manufacturers of homeopathic drugs for allegedly marketing a product without substantiation.
Because of this unique status within FDA, the court concluded that FDC Act preemption does not apply to homeopathic drugs. Section 751 of the FDC Act preempts any state or local laws that relate to the regulation of a drug and that are different or in addition to federal law, but the court explained that FDC Act § 751(d) contains exemptions to preemption, including an exemption for products that are not marketed pursuant to FDA approval or final FDA regulation. The court reasoned that a homeopathic drug falls within this exemption because homeopathic drugs are not approved and are not marketed pursuant to a final FDA regulation.
In the alternative, the court also concluded that plaintiff’s claims are not preempted because they do not constitute state-imposed requirements that are “different from or in addition to” the federal requirements. The court explained that plaintiff’s claims are premised on the allegation that Boiron’s marketing is false and misleading, and under the FDC Act, a drug with false or misleading labeling is misbranded. According to the court, the claims would be preempted only if the state law requirements are not identical to the FDC Act. Boiron argued that the state law requirements are not identical to the FDC Act because, if the plaintiff’s allegations were true, Boiron would have to change its labels and advertisements. The court disagreed, stating that if the allegations were true, Boiron would simply have to truthfully state the product’s efficacy or not sell its products, and such relief would not impose requirements different from or in addition to the FDC Act requirements. The court also distinguished the case National Counsel Against Health Fraud, Inc., v. King Bio Pharm, Inc. (133 Cal Rptr. 2d 207), a case where a California state court concluded that because homeopathic drugs were marketed pursuant to the HPUS, “the general efficacy and safety of the remedy ha[d] been substantiated to the extent required by federal law.” The court in this decision stated that it was “not persuaded by the reasoning set forth in King Bio Pharmaceuticals that inclusion in the HPUS is sufficient to guarantee the efficacy and safety of a homeopathic OTC drug.” This statement indicates that the court in Delarosa lacked understanding of the principles of homeopathy, or, despite the recognition of these principles in the FDC Act, simply rejected them.
Boiron also argued that FDA’s Compliance Policy Guide (“CPG”) 400.400, which provides FDA’s opinion on when a homeopathic drug may be marketed, is a formal FDA advisory opinion. The court disagreed, concluding that the CPG is not a formal advisory opinion. Although 21 C.F.R. § 10.85(d)(3) states that a CPG can be an FDA advisory opinion, the court explained that FDA’s foreword to the CPG, which states that CPGs “may derive from a request for an advisory opinion, from a petition outside the Agency, or from a perceived need for a policy clarification from FDA personnel,” shows that the opinion is not a formal advisory opinion.