Consumers have a right to expect that products that claim to prevent, diagnose, treat, or cure serious medical conditions have been reviewed by the Food and Drug Administration (“FDA”) and approved for such marketing. Accordingly, when unscrupulous companies mislead consumers by marketing such products without having been approved the FDA, consumers have a right to hold that company to account in a court of law.
Recently, the Food and Drug Administration (FDA) issued a warning letter to the makers of just such a product — PoppySeed Wash (www.poppyseedwash.com). The FDA found that the product, though advertised as a natural alternative to opioids for relaxation and pain relief, is really just an unlicensed drug. Specifically, the FDA found that the company’s product labelling, website, and social media accounts all made claims that consumers could use PoppySeed Wash for the cure, mitigation, treatment, or prevention of disease.
The FDA noted, however, that the product “is not generally recognized as safe and effective” for its advertised use and is, therefore, a “new drug” that “may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA,” which has not been given. Moreover, the FDA noted in its warning letter:
A drug is misbranded . . . if the drug fails to bear adequate directions for its intended use(s). . . . Your PoppySeed Wash product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for use for a layperson to use your product safely for its intended purposes. Accordingly, your PoppySeed Wash product fails to bear adequate directions for its intended use and, therefore, the product is misbranded . . . .
When consumers purchase a product reasonably believing, because of deceptive and misleading product claims, that the product is safe and approved to use, when it is not, the company selling that product has been unjustly enriched at consumers’ expense. The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully brought lawsuits on behalf of consumers aggrieved by such deceptive product claims. If you or someone you know has purchased products from PoppySeed Wash based on the claims made on its website or social media accounts, please contact us today for a free consultation regarding your legal options.