[T]he FDA allows a private organization [Homeopathic Pharmacopoeia of the United States (“HPUS”)] to designate which homeopathic drugs meet certain (and unknown) standards for strength, quality and purity. . . . [T]he FDA did not review any studies or information on homeopathic drugs .
The FDA does not impose additional standards for strength, purity, quality, safety, or efficacy on homeopathic OTC remedies. Indeed, the FDA has advised that unless a homeopathic remedy is being offered for use (or promoted) significantly beyond recognized or customary practice of homeopathy, federal policies on health fraud do not apply. And perhaps most significant, a product’s compliance with requirements of the HPUS . . . does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.
The . . . decision to defer to the FDA’s labeling regulations relie[s] in no small part on the FDA’s comprehensive process that test[s] the safety and efficacy of the drugs which it regulate[s].