Even before the coronavirus pandemic, CBD and herbal product manufacturers were getting in trouble with the U.S. Food and Drug Administration for making unsubstantiated claims about their products.
But the coronavirus has ushered in more dubious claims – and more warning letters from the FDA directing companies to immediately stop.
The letters have hit businesses across the country that are promising to cure or make people immune from COVID-19.
Even former NFL player Kyle Turley drew attention from federal regulators this month for promoting CBD on social media as an effective treatment for coronavirus. Turley, who played eight seasons in the NFL with three teams, was encouraging people to use CBD from his company, Las Vegas-based NeuroXPF.
Asa Waldstein, the incoming chairman of the Cannabis Committee at the American Herbal Products Association, shared his experience with Hemp Industry Daily on how he advises companies to maintain compliance with the FDA’s labeling and marketing guidelines .So what claims and labeling – and even hashtags – should your company avoid to stay on the FDA’s good side?
What types of marketing or claims should CBD companies (or other companies that sell herbal products) avoid, so they don’t get a warning letter from the FDA?
Simply put, companies should avoid the use of the words COVID-19, coronavirus, Wuhan virus, and corresponding language. As a general rule, anything a drug is indicated for is most likely a claim (e.g. aspirin indicated for fever).
Hashtags are also claims. Using #coronavirus, for example, on an otherwise compliant marketing campaign can alert the FDA and give the appearance you are insinuating your product is useful for the coronavirus.
The recent warning letters cited companies not just for making claims, but also for insinuating them.
What happens if a company doesn’t comply with the FDA’s order to cease and desist?
If a company does not comply with FDA requests, they may face product seizure or criminal prosecution.
What are some of the most outrageous claims you’ve heard companies make?
Here is a particularly egregious statement citing during a recent warning letter: “If colloidal silver has killed coronavirus strains in past laboratory test, then the current coronaviruses should also be killed. Protect your immune system; try Colloidal Silver 1100 PPM Immune Support.”
Another company started a website…for the purpose of selling products designed for coronavirus prevention.
Coronavirus aside, what should companies be mindful of when they put certain claims on their products so they don’t get in trouble with the FDA?
Simply put, anything posted on social media or a company website is considered an extension of the label. The FDA has been reviewing social media in nearly all recent warning letters.
- Testimonials and product reviews should not include any types of claims.
- Although it’s counter-intuitive to social media marketers with limited dietary supplement experience, companies and employees liking or commenting on their social media post with claims is best avoided. Engaging on the post substantiates the claim in the eyes of the FDA.
- Hashtags are considered claims based on FDA warning letter precedent. Adding a hashtag claim (e.g. #concussion, #Alzheimers, #CBDcures) to an otherwise compliant posting can elevate a company’s risk of receiving an FDA warning letter.
- On the flip side, a company making a purely informational post on supporting a cause such as breast cancer awareness is allowable. The company can turn an informational post into a claim by adding a hashtag, calling the customer to purchase their product or by insinuating their product can be useful for breast cancer.
- Any claims being made on videos such as YouTube are now being reviewed and cited in warning letters.
- Infographics are considered claims.
- Informational blogs may be considered claims, especially if a company is using this to sell product (e.g. hyperlinks to shopping carts, product pictures).
- Citing clinical studies make be construed as a claim.
- “Made in the USA” labeling can lead to lawsuits. The statement should only be used when the majority of product components are from the U.S., including packaging and any carrier oil, such as MCT.