Regulation of Homeopathic Products in FDA
Many people ask me about the regulation of homeopathic drugs in the US and about the legal side of homeopathy in FDA in general. So, we’ve decided to provide more info on how the regulation of homeopathic drugs in FDA works. Let’s begin!
Homeopathy, which dates back to the 1700s, is based on the theory that the symptoms of a disease can be treated with minute doses of substances that produce similar symptoms when provided in larger doses to healthy people. Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.
Homeopathic medications are recognized as drugs under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., Section 201 (g)(1) which defines the term “drug” as “articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official national Formulary, (i) or any supplement to any of them .... “
Thus, homeopathic products are drugs as defined by FDA regulations.
In 1988, the FDA announced in the Federal Register (53, Fed. Reg. 21728) their compliance policy for homeopathic drugs: Compliance Policy Guide 7132.15, “Conditions under Which Homeopathic Drugs May Be Marketed.”
This Compliance Policy Guide (CPG), which was revised in March 1995, provides guidelines on the regulation of OTC and prescription homeopathic drugs and describes the conditions under which homeopathic drugs may be marketed in the US. The policy guide reiterates the statutory declaration of the Homeopathic Pharmacopoeia of the United States (HPUS) as the official compendium under the FD&C Act and recognizes the homeopathic status of any drug which is listed in the HPUS.
As previously stated, FDA recognizes the marketing of homeopathic products as long as they meet the conditions set forth in CPG 7132.15. For example, the homeopathic drug must be recognized by the HPUS or an alternative publication that establishes its status as being generally recognized as a homeopathic drug and there must be support for the labeled indications in the homeopathic literature.
According to this policy guideline, homeopathic drugs in general must meet the standards for strength, quality and purity as stipulated in the Homeopathic Pharmacopoeia.
Section 501 (b) of the FD&C Act (21 U.S.C. 351) states:
“Whenever a drug is recognized in both the Unites States Pharmacopoeia and the Homeopathic Pharmacopoeia of the Unites States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the Unites States and not to those of the Unites States Pharmacopoeia.“
The policy mentions A Dictionary of Practical Materia Medica by John Henry Clarke, MD and A Clinical Repertory to the Dictionary to the Materia Medica by the same author. Both historical homeopathic texts are guides and may be reviewed in conjunction with other available literature on homeopathic drugs. Other acceptable reference sources for the use of homeopathic remedies including potencies, dosing and other parameters, are mentioned in the HPUS and include, but are not limited, to the published works of Samuel Hahnemann, Constantine Hering, TF Allen, HC Allen, and John Tyler Kent (in addition to JH Clarke mentioned above).
Compliance of Product Active with HPUS
A first step in the assessment of a potential homeopathic product is to check whether the product’s active materials are listed in the HPUS in their own official monographs.
Each of the product’s active materials should be in compliance as regards strength, quality and purity as set forth in the HPUS and other international homeopathic compendia such as the German Pharmacopoeia, French Pharmacopoeia or European Pharmacopoeia.
It should be verified whether the active drug ingredient in the prospective homeopathic product meets the standards and control specifications of the HPUS or other international recognized pharmacopoeias if standards and controls are not specified in the HPUS.
The regulatory assessment should include whether the used biomarkers of the plant materials are similar to the “standard” plant material as specified in the HPUS.
It should also be confirmed that the plant parts utilized are within the guidelines of homeopathic regulatory documentation in that similar plant parts to those used in the proposed homeopathic drug products have been used previously in other homeopathic preparations marketed in the U.S.
For example, HPUS may specify the use of the whole plant for currently marketed US homeopathic drug products or only dried roots and rhizomes.
Please note that various internationally recognized pharmacopoeias have often been unclear as to the part of the plant that should be used, primarily due to lack of specificity in the historical homeopathic literature.
In addition, pharmacopeia often use descriptive terms for the reported indications or symptoms and therefore the applicant should ensure that these symptoms are associated with the proposed indication of the homeopathic product.
The Use of Homeopathic Drug Combinations
Homeopathic drugs could use one or a number of homeopathic preparations of herbal extracts at specific ratios.
The Homeopathic Pharmacopoeia Convention of the United States passed a resolution (in 1948, reaffirmed in 1981), which permits the combination of homeopathic drugs assuming that each homeopathic active drug is listed in the HPUS.
The homeopathic literature should support the prior use of each active ingredient for the proposed indication(s).
Finally, it should be confirmed that homeopathic product dosage is not only consistent with the homeopathic literature but that it is also compliant with the guidelines in the HPUS and other internationally recognized, official homeopathic compendia.
Homeopathic Products and Clinical Studies
In general, clinical studies are not required to market homeopathic drugs in the U.S.
However, it is recommended that a company performs clinical studies to establish the safety and efficacy of the product for the proposed indications.
Recent developments in the industry as a whole will further stimulate companies to provide satisfactory clinical data for their product claims.
On November, 15, 2016, the Federal Trade Commission (FTC) announced a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.”
The policy statement explained that the FTC will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. That is, companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions. The statement describes the type of scientific evidence that the Commission requires of companies making such claims for their products.
In light of this, besides assuring product safety and efficacy, clinical study data will be helpful to support advertising claims if challenged by the Federal Trade Commission or the National Advertising Division.
Homeopathic Product Labelling
Homeopathic drug products must comply with the labeling provisions of Sections 502 and 503 of the FDCA and part 201 of the Code of Federal Regulations (CFR).
All homeopathic drug products are subject to the FDCA’s prohibition against false and misleading labeling.
Furthermore, as noted in CPG 7132.15, homeopathic drug products “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment” may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
If you have any questions regarding homeopathic products or intend to register the product in US, BioReg is here for you to help.