Marketing of Homeopathic Drug Products: OTC vs. Rx-only
By Eric L. Foxman, Pharm. (Ret.)
On a single day in mid-November, FDA issued five warning letters* to a like number of distributors / manufacturers of homeopathic drug products. The cause? The firms were cited because “the labeling of your… drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as [see below], and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions….”
The list of conditions cited in one or more of the various warning letters include: ADD, ADHD, Alzheimer's disease, asthma, autism, cancer, conjunctivitis, cystic fibrosis, hepatitis C, malaria, measles, multiple sclerosis of the brain and spinal cord, ophthalmia neonatorum, pancreatic cancer, pancreatitis, stroke, typhoid, tuberculosis, and worm related complaints. Additional claims for some were: for brain oedema in ... patients suffering from brain stroke and other brain-related diseases; to help dissolve blood clots induced by stroke or other related diseases; prevention of coronary disease; the most effective homeopathic remedies to get rid of diabetes; and to help regulate blood pressure.
That is quite a list of therapeutic indications! Let’s step back and look at the bigger picture. Homeopathic products meet the legal definition of a drug: “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals [21 USC 321 (g)(1)(B)].” As drugs, they must comply with the labeling requirements for one of two categories: over the counter (OTC), or restricted to prescription (Rx-Only). One of the OTC requirements is that the labeling contain “adequate directions for use.” FDA has always interpreted it to mean “adequate” for a layperson. That phrase is a statutory standard; a drug is considered misbranded unless its label bears “adequate directions for use” which must contain the circumstances (conditions) for which the drug is to be used: the indication for use.
What is an appropriate indication for use for an OTC drug product (whether homeopathic or not)? The Agency’s position is that OTC drugs are intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment. Contrast this with the regulatory definition of an Rx-Only drug: a drug, with toxicity or other potential for harmful effect, or the method of its use, or the collateral measures necessary, which is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. (emphasis added) [21 USC 353 (b)(1)]
Look back at the list of conditions in paragraph two. All of the products were labeled and promoted for OTC sale. Are they self-limiting disease conditions amenable to self-diagnosis and treatment? Is it any wonder the warning letters were issued? Yet, more importantly, what can we learn (or have confirmed) from these?
That OTC homeopathic drug products with labeling which includes “claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions” are subject to regulatory action by FDA.
Before leaving those five warning letters, there is another point that easily could be overlooked. FDA specifically called out a product’s promotional statement as inappropriate for an OTC drug: “Promote cardiovascular well-being, address factors related to heart function, and contribute to the maintenance of a healthy circulatory system.” Obviously, these are all related to cardiovascular conditions, which should be restricted to Rx-only sale.
Yet, the FD&C Act definition of drug includes the following: “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [21 USC 321 (g)(1)(C)]. At the same time, a careful consideration of the wording should lead one to conclude this statement is not addressing any disease, illness or health concern. It is akin to a Structure/Function statement, which might be appropriate for a dietary supplement. However, the product under consideration is not a supplement to the diet, thus it does not fall into that safe harbor category.
I suggest that one should not assume the lack of any Agency comment about this circumstance means the use of Structure/Function-like statements are appropriate for drug products. Similarly, we should not assume the lack of any Agency mention that all of the warning letters’ products lack electronic Drug Listings, means it is legal to market a homeopathic drug in the United States without going through the drug listing process.
For a deeper look at the challenges of OTC indications as well as thoughts on the use of the Drug Facts Panel format, see the Homeopathic Drug Labels: Rx or OTC? which can be found here. For a convenient bullet point guide to differentiating between OTC and Rx status, see When is a Homeopathic Product OTC or Rx? which can be found here. Note: both were published before the CPG 400.400 was withdrawn, but the information is as relevant and binding today as it was at the time of posting.
* Five Warning Letters Published Nov. 17, 2025
FDA Warning Letter to Handelnine Global, LLC dba Navafresh
FDA Warning Letter to Mahita LLC dba PushMyCart
FDA Warning Letter to Swift Digital Group LLC dba Swadesii
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