Is your pharmacy selling homeopathic products? If it is, think again.
September's column [“Fraud in the pharmacy?”] explored the legal definition of “health fraud.” To date, no homeopathic product has ever been proven safe or effective for any medical condition whatsoever. If medical claims are made for any homeopathic product, such claims fall solidly within the legal definition of health fraud.
A year ago, on September 25, 2013, FDA sent Standard Homeopathic Company a warning letter that can be seen at this government website: http://bit.ly/SHCwarning.
The letter reveals that after examining Standard’s website, the district director of FDA’s Compliance Branch charged that numerous Hyland’s homeopathic products were misbranded in violation of the Federal Food, Drug, and Cosmetic Act.
For example, “Arnicaid” was said by Standard to be useful for nerve injury due to blows. “Hyland’s Teething Tablets” were said to be useful for reducing redness and inflammation of the gums. The purported uses of “Hyland’s Vaginitis” and “Hyland’s Restless Legs” are self-explanatory. The company even sold “Hyland’s Infant Earache Drops” and “Earache Tablets.” The letter cites dozens of other examples of illegal claims.
FDA also noted the customer reviews found at the Standard website and stated that “your firm is responsible for ensuring that statements made by customers and included on your websites do not cause your product to be misbranded under sections 502 and 503 of the FD&C Act [21 U.S.C. 353(b)(1)].”
The FDA letter went on to indicate that these products raise several legal issues.
First, the conditions for which these Hyland’s products were marketed required diagnosis and treatment by a practitioner licensed to prescribe drugs. The labeling of these products made them prescription drugs, but they were all sold as nonprescription products (such as might be available in any gas station, airport store, or hairdresser’s salon). As a consequence, the products were all misbranded, because they did not bear the “Rx Only” symbol restricting them to prescription status.
The labeling was also found to be false or misleading because it represented the products as suitable for use by consumers to treat conditions not appropriate for OTC drugs.
FDA warned the company that failure to promptly correct violations could result in legal action without further notice, including, without limitation, seizure and injunction.
In the face of such clearly delineated violations of the law and such strict penalties, did the company take immediate action to avert further trouble? Did it eliminate the language in question or restrict sales of the products to prescription-only?
To see whether the company complied, one need look at just one example cited by FDA, Standard’s claims for “Hyland’s Vaginitis,” as found at http://www.hylands.ca/products/vaginitis.php, on August 19, 2014, almost a year after the letter was issued by the FDA. The wording on the website remains identical to the wording questioned by the FDA almost a year earlier.
It appears that to date, Standard Homeopathic has refused to rename the product, move it to prescription status, or modify the labeling to avoid charges of misbranding, while the company and FDA remain, apparently, in dialogue. It seems likely that its stalling actions have allowed it to reap additional profit.
The informed pharmacist is still the best line of defense against such products. When patients ask about them, it is our professional, legal, and moral obligation to disclose that there is no evidence of safety and efficacy for homeopathic products, and that many are marketed illegally. We should then recommend products of proven safety and efficacy, and refer patients to their prescribers when appropriate.
Selling misbranded homeopathic products is a dishonest act on the part of the individual pharmacist, and making claims for the safety and efficacy of any homeopathic product is fraudulent.
In a larger sense, homeopathic products make a mockery of the concept of pharmaceutical care and cast a cloud over all of us who value our patients’ health over profit.
Other healthcare professionals have every right to regard community pharmacists who peddle homeopathic products as little better than snake-oil salesmen. We must strive to be better than that.
Steven Prayis Bernhardt Professor at the College of Pharmacy at Southwestern Oklahoma State University. Contact him at email@example.com.