You work hard to build your business. This endeavor requires time, money, and effort. And because your success matters most at Sisel, we want to make sure your business is safe and long-lasting. Unfortunately, it can all be in jeopardy if we don’t adhere to the rules set by the FDA, FTC, and other regulatory institutions.
Our Policies and Procedures are in place to help you stay in compliance. Now we’re adding another tool to ensure your business is protected and remains successful. Compliance Coaching will provide ongoing training and updates on the regulatory environment, helping you with what you can and can’t say/do with your Sisel business.
What is a Drug Claim vs. a Structure/Function Claim?
Our first topic is about making claims. You’ll notice on every label we have a disclaimer that states: “…This product is not intended to diagnose, treat, cure, or prevent any disease.” This is a statement required by the FDA to distinguish between products qualifying as drugs and those that don’t.
Sisel’s products are not drugs. Making any claim about them would be impossible if not for the DSHEA Act passed in 1994. The Dietary Supplement Health and Education Act (DSHEA) was a big win for the supplement industry. This federal law allows us to make claims about products without requiring the federal scrutiny a drug has to go through before being approved by the FDA. We still can’t claim our products cure or help with any disease, but we can say they help our body’s functionality.
Here’s an example:
- “I took product X and my bronchitis went away.” This is a drug claim.
- “I took product X and my breathing improved.” This is a structure/function claim.
Product X may very well have cured your bronchitis, but by saying so you’re telling the FDA that product X is a drug and you have accredited research to back your claim. While the difference may seem minor, the FDA takes it very seriously. Making a drug claim about any product can get you and Sisel in trouble with the FDA.
Instead, emphasize how these products help improve the functions of your body. Do they help you stay energized? Recover faster? Feel younger? These are all structure/function claims and safe to use. Again, avoid stating or implying they cure specific diseases or ailments.
Ultimately, your experiences are real and unique. We’ve seen your testimonials and incredible results and want you to express them in a way that is sincere but also compliant with our policies and procedures and with regulatory entities.