Facebook, LinkedIn, Twitter, Pinterest, Instagram – just a few of the common words today that were unheard of not that long ago. Collectively they, and similar internet-based platforms, are known as social media and there are not many people that do not use at least one of these in their daily interactions with family and friends.
Because of this widespread use, businesses have also recognized its potential as a marketing tool, allowing them to promote their products or services to a much larger audience than may have been previously accessible. But, for those industries regulated by the Food and Drug Administration, there are additional implications in terms of maintaining compliance to applicable laws and regulations.
As such, the FDA issued 3 draft guidance documents this year pertaining to the use of social media for product advertising and promotion in an effort to help industry meet its regulatory obligations. Although the scope of the documents is not applicable to OTC products, those companies that manufacture or distribute OTC drugs, dietary supplements or cosmetics should consider the general principles contained within, both in the development of their labeling as well as any subsequent marketing strategy using social media. In addition, as the advertising and promotion of these consumer products is governed by the Federal Trade Commission (FTC) companies must be aware of, and in compliance to, regulations promulgated by that agency.
When using social media for promotional activities, companies should take into account the following to ensure they are meeting both FDA and FTC requirements:
• information should be presented in consumer-friendly language and consistent with FDA-required labeling for the product
• information must be true; not false or deceptive in any way; any claims should be substantiated
• information must present a fair balance between product effectiveness as well as any risk, and these should be published together in the same communication
• if using a social media platform with character-space limitations, a mechanism (such as a hyperlink) should be provided to allow direct access to more complete information
• any use of endorsements and testimonials should incorporate recommendations in the appropriate FTC Guides concerning such statements
While the points listed above are easily understandable for social media platforms controlled and operated by the company manufacturing or distributing a particular product, a challenge is presented when independent third parties get involved. This User Generated Content (UGC) might appear on the interactive part of a company website or social media platform, or it may appear on a site that is independent of the company. Sometimes this content is continuous and interactive such as seen on Facebook or it might just be a forum that allows information to be posted. In such cases, companies should be careful how they react or respond to such posts as there have been instances whereby these have been considered endorsements of unapproved claims, resulting in issuance of an FDA warning letter.
Neither the FDA nor FTC are likely to hold companies responsible for third-party content and companies should be advised to avoid use of such statements in their own product advertising and promotions. In addition, companies should have a written policy as to how they will address, if at all, situations in which UGC is incorrect or inaccurate, especially if there is a safety consideration or legal risk associated with a posting.
Social media is here to stay and will likely expand in the years ahead. It is important to recognize that, while it will provide businesses with many opportunities for growth and expansion, this must be accompanied by a commitment to maintaining compliance to all relevant government regulations.