Despite FDA pronouncements, industry coalition action the coronavirus claims warning letters keep coming

By Hank Schultz

- Last updated on GMT

FDA photo
FDA photo

Related tags regulations coronavirus COVID-19

The US Food and Drug Administration has issued an additional six warning letters in recent days on coronavirus claims. The letters coincide with an industry coalition raising a red flag on the growing flood of such claims on dietary supplement-type products.

The warning letters, which were issued in conjunction with the Federal Trade Commission, were posted on FDA’s website on April 7 and 8.  They were all the result of reviews of marketing language on company’s websites.

Warning letters run gamut of products on market

The letters are addressed to two companies manufacturing CBD products, two homeopathic companies, one company marketing essential oils, a company manufacturing TCM herbal products, and even one company manufacturing a product for pets’ respiratory health that it claimed was “good for all species.”

Among the claims cited in the warning letter was this claim from Ananda Apothecary, an essential oils purveyor: “Build and Manage Your Immunity: A Coronavirus Antidote? What if you had a magic key to help keep your immune system strong and less likely to succumb to illness?”

Another claim on CBD comes from the company Indigo Naturals: “Is CBD An Anti-Viral Agent For Coronavirus, Influenza, MERS, and SARS . . . CBD Anti VIRAL? . . . The headlines are frightening from Wuhan, China when we first wrote this. . . .What about CBD? We’ve seen reports of CBD having both antibacterial and antiviral effects.”

Another CBD claim from the company CBD Online Store: “Can CBD Help With The Corona Virus? . . . Inflammation is the problem here . . . We have been saying on our blog since the beginning about the powerful anti-inflammatory effects of CBD.” 

As part of an urgent response to the disease crisis, FDA is giving companies only 48 hours to respond via email to the combined FDA/FTC warning letters.  Typical practice up to the advent of the current coronavirus crisis has been to give companies 15 days to notify FDA in writing of how it plans to address the violations raised in a warning letter. 

Warning letters coincide with industry action

The latest raft of warning letters coincides with a communication from a coalition of dietary supplement industry trade associations that urges retailers, both online and brick and mortar, to join in the struggle to hold the line on illegal COVID-19 disease treatment claims.

In a joint press release issued this week​ four trade groups said they, “commended the Food and Drug Administration (FDA) for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19.”

The four trade associations that signed on the release are the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition and the United Natural Products Alliance.  The four trade associations have had a practice for a number of years of meeting monthly to discuss industry-wide issues.

Steve Mister, president and CEO of CRN, said yesterday’s action follows a warning the coalition put out to warn the marketplace about illegal COVID-19 treatment claims.

“We wanted to put another stake in the ground from our standpoint to remind the press and the rest of the industry that the trade associations have no patience with this,” Steve ​Mister, president and CEO of CRN told NutraIngredients-USA.

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