Many ‘Dietary Supplements’ Sold by Amazon Are Defective, Misbranded Drugs, Class Action Alleges

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A proposed class action alleges many of the purportedly safe, legal and therapeutic dietary supplements sold by Amazon are in fact misbranded “defective drugs” that are illegal and unapproved by the Food and Drug Administration. 

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The 43-page lawsuit was filed in California nearly five months after Amazon received from the FDA a warning letter asserting that the retailer, through its Fulfillment by Amazon service, has placed into the stream of commerce a slew of unlawful drugs “masquerading as therapeutic dietary supplements” whose labels make “unapproved disease claims” and bear symbols that resemble FDA certification. 

The suit moreover alleges Amazon, the largest seller of health and wellness products in the country, and its partners’ promotion and sale of unapproved, misbranded drugs has led to “a proliferation of like violations and illegal sale[s]” by other companies and in other marketplaces, including for products implied to be able to treat, cure or prevent diabetes, high blood pressure, Alzheimer’s disease, arthritis, depression, prostate cancer and other ailments. 

A key distinction in the lawsuit is the difference between a drug and a dietary supplement. The case says that in order for a product to qualify as a dietary supplement instead of a drug requiring prior FDA approval before being sold publicly, the item must bear prominently on each panel of its label with a health-related claim a disclaimer that reads “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” 

The products at issue do not bear this FDA-mandated disclaimer and are thus “misleading, misbranded, unapproved, and unlawful drugs that may not be placed in interstate commerce,” the filing contends. 

“The disclaimer requirement exists for a reason: to warn consumers,” the lawsuit stresses, noting that the warning stems from the FDA’s express recognition that “few dietary supplements have been the subjects of adequately designed clinical trials.”

Among the misbranded products mentioned in the lawsuit is Carditone, which is touted as offering cardiovascular and blood pressure support and as “recommended by doctors” and “essential for heart health,” the filing says. As the product does not bear the FDA-mandated disclaimer, it is an unapproved drug that cannot be legally sold, the lawsuit contests. 

“As with other Products on Amazon.com, people who self-diagnosis [sic] and treat with Carditone are at risk of serious bodily injury in addition to suffering economic injury caused by purchasing an illegal and defective drug from Amazon.com,” the complaint relays. 

Another product, Himalaya Organic Arjuna, is similarly positioned as beneficial to heart health and blood pressure, and as “clinically studied for safety and efficacy,” the case continues. The item, like Carditone, lacks mandatory disclaimers, the suit says.

Products mentioned in the FDA's warning letter to Amazon include certain items touted as mole and skin tag removers. The agency pointed out that "[t]here are no over-the-counter ... drugs that can be legally sold for mole or skin tag removal," and that moles should be evaluated by a healthcare practitioner as self-diagnosis and treatment "could lead to delayed cancer diagnosis or even cancer progression."

According to the lawsuit, the “defective and illegal nature” of Amazon’s supplement labeling is common to items touted as treating a number of conditions and ailments, including diabetes and memory loss, which are historically expensive to treat. 

The lawsuit looks to cover all consumers living in California who bought one or more products purporting to be dietary supplements, as defined by the Federal Food, Drug, and Cosmetic Act, from Amazon.com during the applicable statute of limitations period. 

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