Companies that fall under the umbrella of the FDA need to consider compliance and how their marketing and social media messages adhere to any new regulations. With the explosion of social media platforms, some questions that may come up include, how can companies follow the regulations using real time communications or tools with space limitations (i.e. Twitter)? Questions like these are still being sorted out. Below are five things you need to know about FDA and social media compliance. For this example, we will go over some things to look out for if your company has a product that has not yet been approved by the FDA but still falls under the FDA regulatory umbrella. When using social media, remember these five things:
A product may not lawfully make either express or implied disease claims (i.e., claims that the product is intended to treat, cure, mitigate, or prevent a disease or condition of disease). If a product being marketed makes a disease claim, the FDA may take enforcement action against the marketer on the basis that the product is in fact an unapproved new drug.
Adequate Substantiation of Structure/Function Claims
You must have adequate substantiation on file for every structure/function claim made in your marketing materials. This includes claims that individual ingredients affect the structure or function of the body in a certain way, as well as claims that the ingredients work together synergistically to affect structure or function. In order to serve as substantiation for a structure/function claim, a study or trial must be related to that structure/function claim.
Adequate Substantiation of Other Statements
In addition to having adequate substantiation on file for structure/function claims, you must also have adequate substantiation on file for other statements you make about your product. For example, this would relate to any claims of “few to no side effects.” If such claims are made online or in social media without adequate substantiation, it may be difficult or impossible to defend a product liability personal injury action.
Use of Testimonials
When you include a testimonial in your promotional materials, you thereby adopt any and all claims contained within that testimonial as your own product claims. Regardless of whether a testimonial is true, it may not be included within your promotional materials if it contains a disease claim. In addition, if any testimonial contains a claim regarding a result that is not typical or that is not to be expected, you must include a statement stating as much and disclosing the generally expected performance of the product.
By linking to outside materials (such as articles, websites, videos, and studies) you adopt as your own the claims contained in those materials.
There are many other issues in addition to these five to consider when dealing with online and social media. For example, the 5 things highlighted would vary dependent on whether the product has been approved by the FDA or not. Make sure to arm yourself with the latest knowledge and updates so you can remain compliant and have a healthy online relationship with your customers for years to come.