Joint health supplements that splash a claim to treat arthritis across the label are sure to get the attention of the regulatory folks at the Food and Drug Administration (FDA). Even the mere implication of treating the big A with claims to help reduce joint pain, inflammation, or stiffness is enough for the agency to take notice. The FDAs final rule on what body benefits are permissible for joint health supplements is clear. These claims are not in compliance with the Dietary Supplement Health Education Act (DSHEA), and the FDA doesnt take kindly to their use on supplement labels.
Whats more, these claims alone are enough to transform high-quality supplements with serious nutritional benefits for joint health into misbranded drugs subject to regulatory challenge. Enter the FDA, exit the products all because of a word choice gone bad.
Bending the Rules
Savvy marketers know the rules of the road and can quickly spot an implied claim to treat arthritis. In their final rule, the FDA states, There are many possible ways to imply treatment or prevention of disease, from listing the characteristic signs and symptoms of the disease to providing images of people suffering from the disease. In the eyes of the FDA, joint pain, stiffness, and inflammation are characteristic signs and symptoms of arthritis. So, these informed marketers focus their time, money and talent on creating joint health claims that have strong consumer appeal while staying squarely within the regulations.
I often wonder why other marketers gravitate toward edgy claims, particularly when their right-brain brilliance can conjure up so many good ones that are backed by science and in full compliance. In my experience, many are simply unaware of the limits of DSHEA.
Ingredient Suppliers to the Rescue
If you are a knowledgeable ingredient supplier, you are in a prime position to help. After all, you know the body of research behind your ingredients, and you can deliver it in a way that is truly meaningful to marketers: a list of suggested DSHEA-compliant claims backed by research. Its as easy as adding the claims to a sell sheet, a mock label, or another stock item that you can update as new research becomes available. This includes basic structure function claims such as supports cartilage and joint function, promotes joint flexibility and mobility, and helps maintain active joints. If backed by research, suggest temporal claimsa favorite among marketerssuch as promotes joint comfort in as little as [X] days or weeks. And, if you really want to see a marketer smile and you have the data suggest a comparison claim such as promotes joint flexibility better than [Y].
Ingredient suppliers who share their expertise in this way make the label development process a breeze. Everyone wins with this team effort. What better way to shine the spotlight on quality ingredients than with creative label claims that sail through legal and regulatory review and head straight to the final packaging? Of course, the biggest winner is the consumer who can benefit from quality supplements that have staying power thanks to label claims that pass regulatory muster.
NOTE: For more about joint health claims, please read John Shaws post from last week.