By Susan Crane, Independent Advisor, OTC Drugs and Labeling
Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use of the internet and social media has added increasing complexity to the issue for the agency as well as for FDA-regulated industries.
In 2014, the FDA issued three draft guidance documents, none of which have yet been finalized. Although these were applicable only to prescription human and animal drugs and medical devices, it’s reasonable to expect that the FDA believes these same principles would apply to over-the-counter drugs, dietary supplements, foods and cosmetics.
The first guidance clarified FDA’s position on what constitutes interactive promotional media and how manufacturers, packers, distributors and those entities acting on their behalf can fulfill their regulatory obligations with regard to such communications. The other two documents detailed how firms should go about correcting misinformation that is disseminated through a third-party and how risk and benefit information should be presented for those social media platforms with character space limitations, e.g., Twitter.
These guidance documents stress that firms are responsible for promotional communications and other content on internet-based platforms that they own, control, create, influence, or that are operated by, or on behalf of themselves (or any employee or agent working for them.) For content posted on third-party platforms, a firm may also be responsible if it has any control over or influence on that platform. The FDA recommends that firms clearly disclose their involvement with any platform for which they own or influence the content.
However, the internet and associated technologies have made it easier for those not affiliated with these firms to disseminate product information. This user-generated content (UGC) created by third-party entities may be incorrect or incomplete, thus potentially endangering public health either by understating safety information or inflating the benefits of a particular product.
The FDA’s position is that firms are “generally not responsible” for third-party UGC as long as they are truly independent of its source. However, if a firm voluntarily chooses to correct misinformation of which they become aware, the FDA has set forth specific recommendations as to how this should be accomplished and recommended that records be maintained accordingly.
Although they may not be held responsible for content generated by third parties, they should be careful not use such information or endorsements in their own advertising and promotions. In addition, firms should consider correcting any misinformation of which they become aware, particularly if it is a safety issue.
In addition to FDA requirements, the Federal Trade Commission is responsible for regulations specific to 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, social media advertisements may promote the product for its intended use but lack the necessary warnings, as was the case 2 years ago with firms marketing e-cigarette products, prompting the FDA and FTC to issued joint warning letters.
In all cases, firms must ensure that any communication for which they have control or oversight is truthful, not misleading and substantiated. This includes the use of social media influencers, another area that the FDA is studying in an effort to determine the impact these endorsers have on consumer behavior and perception.
Social media has proven to be a powerful tool for companies to advertise and promote their products. There is no doubt that the FDA, FTC and other regulatory bodies worldwide will further define and clarify their approaches to monitoring such activity so it would be wise for industry to become familiar with 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.