It is clear that the Internet and social media are having a profound effect on the dietary supplement business, enabling rapid dissemination of product information to a wide audience of potential customers. However, this capability brings both risks and responsibilities from a regulatory standpoint.
Recognizing this, the FDA issued several draft guidance documents this year to assist industry in meeting its regulatory obligations. While issued for prescription human and animal drugs and medical devices, the documents should be used to gauge the agency’s current thinking with regard to social media and its use in promoting FDA-regulated products.
For dietary supplements, the FDA regulates the actual content of the labeling and the Federal Trade Commission is responsible for regulations regarding advertising. However, on social media platforms the information may be presented in such a way that it could be considered both labeling and advertising. For example, a website or Facebook page may include product usage details and claims, or a link to independent scientific literature, or additional links to purchase the product or “Share” or “Like” it to another site.
Indeed, two recent FDA warning letters exemplify this issue. In the first letter, Bhelliom Enterprises Corp. was cited for making false and misleading claims on its website with regard to two of its dietary supplement products. These therapeutic claims clearly established the products as drugs, intended for use in the cure, mitigation, treatment or prevention of disease. In addition, it was noted that the website for one of the products referenced a publication in which there was an implication that, within the context of the labeling, the product could treat or prevent a specific disease.
The second letter, issued to the dietary supplement company Zarbee’s Inc., cited the firm not only for making false claims but also for personal testimonials that had been posted and subsequently “Liked” on their Facebook page. These “Likes” were considered equivalent to an endorsement or promotion of Zarbee’s products that were, as formulated and labeled, considered “new drugs” and hence subject to FDA oversight.
Another consideration is that social media has enabled independent firms and consumers to disseminate product information. This presents a risk as the communications may be incorrect or incomplete, thus potentially endangering public health either by understating the safety, or inflating the benefits, of a particular product. While the FDA’s position is that companies are “generally not responsible” for third party content, they should avoid using such information or endorsements in their own advertising and promotions. In addition, they should consider correcting any misinformation of which they become aware, particularly if it is a safety issue.
Social media is a powerful tool and fast-evolving information platform. The FDA is clearly paying attention to this issue and taking enforcement action where appropriate. Likewise, there is no doubt that the FDA, FTC, and other regulatory bodies worldwide will further define and clarify their approaches to monitoring and regulating advertising and promotion of products this way.
It would therefore be wise for the industry to become familiar with current agency expectations and stay abreast of future developments. In addition, companies should have their websites and social media sites reviewed for compliance with FDA regulations to ensure that all of the content is truthful, substantiated, permissible, and not misleading.