The Federal Trade Commission (FTC) has slammed homeopathic drugs with a guidance document on substantiation. This is perhaps the biggest regulatory backlash against homeopathic medicine since the homeopaths were labeled “cultists” during the war by allopathic medicine.
CPG 400.400: FDA’s Homeopathy Compliance Guide
FDA regulates homeopathic drugs under its Compliance Policy Guide, Section 400.400, Conditions Under Which Homeopathic Drugs May be Marketed (“Homeopathic CPG”).
In this guidance, FDA notes that the FDCA “recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (the “HPUS”).
The guidance defines “homeopathic drug” as:
Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements. The potencies of homeopathic drugs are specified in terms of dilution, i.e., 1x (1/10 dilution), 2x (1/100 dilution), etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics. Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.
The Homeopathic CPG sets forth labeling requirements for homeopathic drug products, including:
- Specific information that must be on the label, such as name and place of the manufacturer, packer, or distributor.
- Directions for use.
- Statement of ingredients.
- Established name; container size, statement of identity, declaration of net quantity of contents and statement of dosage.
- Prescription drug legend and statement of dosage, for prescription drug products.
- Indications for use, for OTC homeopathic drug products.
Additional regulatory requirements include:
- All firms which manufacture, prepare, propagate, compound, or otherwise process homeopathic drugs must register as drug establishments.
- Homeopathic drug products must be packaged in accordance with the FDCA.
- Homeopathic drug products must be manufactured in conformance with current good manufacturing practice, Section 501(a)(2)(B) of the Act and 21 CFR 211. However, due to the unique nature of these drug products, some requirements of 21 CFR 211 are not applicable.
Even if a manufacturer of homeopathic drugs meets these standards, the manufacturer still has to make valid claims.
OTC v Rx
In the Homeopathic CPG, FDA distinguishes over-the-counter (OTC) from prescription (Rx) homeopathic drug products as follows:
Those products that are offered for treatment of serious disease conditions, must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC.
… [FDA] compliance personnel should particularly consider whether a homeopathic drug is being offered for use (or promoted) significantly beyond recognized or customary practice of homeopathy. If so, priorities and procedures concerning the agency’s policy on health fraud would apply. (See CPG 7150.10 “Health Fraud-Factors in Considering Regulatory Action” 6/5/87).
The Homeopathic CPG also notes, with respect to prescription/OTC Status:
The criteria specified in Section 503(b) of the Act apply to the determination of prescription status for all drug products, including homeopathic drug products. If the HPUS specifies a distinction between nonprescription (over-the-counter (OTC)) and prescription status of products which is based on strength (e.g., 30x) – and which is more restrictive than Section 503(b) of the Act – the more stringent criteria will apply. Homeopathic products intende solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
The guidance document also discusses homeopathic home remedy kits:
Homeopathic home remedy kits may contain several products used for a wide range of conditions amenable to OTC use. When limited space does not allow for a list of those conditions on the labels of the products, the required labeling must appear in a pamphlet or similar informational piece which is enclosed in the kits. However, as a minimum, each product must also bear a label containing a statement of identity and potency.
FDA’s rules, though, are only one part of the equation. FTC is the other.
FTC Enforcement Policy on Marketing Claims for OTC Homeopathic Drugs
FTC threw down the regulatory gauntlet to homeopathic drug manufacturers with its Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs With this Policy Statement, FTC has signaled more active enforcement against manufacturers and distributors of homeopathic drug products with regard to efficacy claims.
The Policy Statement states that it applies only to OTC products intended solely for self-limiting disease conditions amenable to self-diagnosis of symptoms and treatment. However, the Policy Statement notes that marketing claims about the efficacy about other homeopathic products are subject to similar requirements.
Further, the Policy Statement takes a dim view of homeopathy, as noted by this statement:
In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts….
“Not based on modern scientific methods?”
This harkens back to the times when AMA called chiropractors, homeopathic doctors, and others, “cultists.”
Citing the Homeopathic CPG, FTC notes that OTC homeopathic drugs must be labeled as homeopathic and their labeling must display at least one major OTC indication for use; however, homeopathic drug product claims must be truthful and must be substantiated.
Efficacy and safety claims for homeopathic drugs are held to the same standards as similar claims for non-homeopathic drugs.
Put another way, claims about homeopathic drug products that involve efficacy or safety will be subject to the same standards as new drugs that are not homeopathic.
FTC Ups the Ante
FTC will evaluate “the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts believe is reasonable.”
For health, safety, or efficacy claims, FTC requires “competent and reliance evidence,” defined as:
Tests, analysis, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and [that] are generally accepted in the profession to yield accurate and reliable results…. In general, for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing.
It’s not only that the standards are very rigorous, though; FTC goes back to the idea that homeopathy doesn’t work, because it can’t (and therefore it doesn’t work!).
The Policy Statement goes on to note that for most OTC homeopathic drugs, “the case for efficacy is based solely on traditional homeopathic theories,” and that is inadequate substantiation.
Read that again. Because homeopathy isn’t based on the science everyone else agrees on, the efficacy of homeopathic drugs can’t be proven.
Further, “perfunctory disclaimers are unlikely to communicate the information necessary to make claims for OTC homeopathic products non-misleading.”
The Policy Statement goes on to discuss disclaimers in some detail, noting “the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion.”
FTC looks to the overall “net impression” of marketing to assess whether the marketing complies with applicable law. All marketing must be truthful, non-misleading, and effective in disclosing “the basis for an efficacy claim.”
This is worth reading very carefully. Trying to substantiate homeopathic drug claims is an “inherent contradiction.”
The Policy Statement does state that a marketer “may include an indication for use that is not supported by scientific evidence so long as the marketer effectively communicates the limited basis for the claim in the manner discussed above.” This allowance is of course qualified by the Policy Statement’s discussion of disclaimers and disclosures, and general expression of skepticism toward homeopathic drug product claims. While we have yet to see what enforcement action FTC will take, on the heels of the Policy Statement, the regulatory environment looks fairly hostile.
The bottom line is that manufacturers and distributors of homeopathic drugs must tread carefully in terms of claims, given FDA rules and FTC’s enforcement stance around homeopathic drug products.