Regulatory Focus™ > News Articles > Should FDA Make Changes to the Way it Regulates Homeopathic Products? Agency Wants to Know

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Posted 24 March 2015 | By Alexander Gaffney, RAC

Should FDA Make Changes to the Way it Regulates Homeopathic Products? Agency Wants to Know


The US Food and Drug Administration (FDA) regulates many types of products—drugs, medical devices, cosmetics, food, lasers and tobacco among them. But you'd be forgiven if you forgot the agency regulates another type of medicine: homeopathy.

Now FDA wants to know if its regulatory framework for regulating homeopathic products is adequate, and whether changes are needed.


When you think of the term "drug," you most likely think of traditional pharmaceutical products—chemically or biologically derived products which treat the underlying cause of a disease or its symptoms.

But federal law defines the term "drug" more broadly. Under Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act), a "drug" is defined as any article(s):

recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

The key phrase there as it relates to drug regulation: Any product recognized by the US Homeopathic Pharmacopoeia (HPUS) is defined as a drug.

As a result, the regulation of homeopathic medicines is overseen by FDA, which regulates them under the terms of a 1990 Compliance Policy Guide (CPG), Conditions Under Which Homeopathic Drugs May be Marketed. Prior to the 1990 CPG, homeopathic products could only be sold with a prescription. The CPG allowed homeopathic products to be sold either with a prescription or directly to consumers as over-the-counter products.

While FDA defers to HPUS as to matters of product strength, quality and purity, the agency maintains that compliance with HPUS standards—or any other standards—"does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use."

Accordingly, homeopathic products must meet strict labeling standards set by FDA. OTC homeopathic medicines, for example, may only be sold "for self-limiting disease conditions amendable to self-diagnosis (of symptoms) and treatment."

Companies which fall afoul of this regulatory req

uirement may be subject to warnings or enforcement action by FDA. For example, in March 2015 FDA issued a warning that over-the-counter homeopathic asthma products shouldn't be used because they had "not been evaluated by the FDA for safety and effectiveness." Asthma is also not a "self-limiting" disease.

A New Look at Homeopathy

But now FDA has a question for the public: Are changes needed to the way it regulates homeopathic products?

FDA says it plans to soon revisit its regulatory framework—the 1990 compliance and policy guide—used to oversee homeopathic products.

In a notice posted on FDA's website, it said it will hold a public hearing in April 2015 "to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products."

The meeting comes in the wake of new research published by the Australian government, which found that homeopathic treatments simply do not work.

"There was no reliable evidence from research in humans that homeopathy was effective for treating the range of health conditions considered: no good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment," Australia's National Health and Medical Research Council wrote in a widely-publicized statement.

Whether or not that will influence FDA's homeopathic framework remains to be seen, but could be a source of contention at its upcoming meeting on 20-21 April 2015.


FDA Meeting Notice


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