FDA Says Context Can Create Implied Disease Claims for Your Dietary Supplements

FDA Says Context Can Create Implied Disease Claims for Your Dietary Supplements

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    In today’s video, we talk about even more common labeling mistakes that dietary supplement manufacturers and distributors make when making marketing claims for their products.

    Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues so you can launch, or scale your health and wellness product or service.

    This is one in a series of videos, and so we will pick up the thread where we left off with Criterion 5 out of 10 used by FDA to determine whether a dietary supplement manufacturer or distributor, which could include a clinician, a physician, chiropractor, distributing supplements whether you have made a disease claim.

    FDA says: “Criterion 5.  Claims that a product belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease.”

    It’s very similar to Criterion 4, which dealt with the product name and use of pictures, symbols, vignettes and so on.

    FDA says that examples of such “product classes” that make disease claims are these: analgesics, antibiotics, antidepressants, antimicrobials, antiseptics, antivirals, or vaccines.

    This is especially important in the era of COVID-19, where many manufacturers and distributors have gotten in trouble with the FDA for making claims about their product treating viruses or being antivirals or even being vaccines.

    Again, FDA looks to overall context, and sometimes you can simply say that the product helps with temporary issues, for example, a dietary supplement might be a “diuretic that relieves temporary water-weight gain.”

    Criterion 6 claims that the product substitutes for a product that is a disease therapy.  For example, we have seen dietary supplement companies trying to compare their supplement to aspirin, or to some conventional drug for a disease. Doesn’t work.

    Criterion 7 is similar, and deals with a claim that the product augments a therapy or augments a drug intended to diagnose, mitigate, treat, cure, or prevent a disease.  Now, FDA does have carve-outs and allows saying that the dietary supplement provides general nutritional support, or otherwise makes a valid structure/function claim.

    Criterion 8: “Has a role in the body’s response to a disease or to a vector of disease.”  This is where a lot of dietary supplements get in trouble.  FDA notes: “A claim that a dietary supplement fights disease or enhances disease-fighting functions of the body is a disease claim.” No go, that’s a drug.

    Even saying something like, “supports the body’s antiviral capabilities,” is a disease claim, because, FDA notes, “the context of the claim is limited to the disease prevention and treatment capabilities.” So, you mentioned antiviral, no go.

    Of course, FDA have carve-outs here and allows a structure/function claim like, “supports the immune system.”

    Criterion 9, “Claims to treat, prevent, or mitigate adverse events associated with a therapy for a disease.”

    And Criterion 10 is the catch-all, kitchen sink – watch out: “Otherwise suggests an effect on a disease.” Again, context is everything.

    We can do a fair amount with an early read, you would probably benefit from having a Legal Strategy Session with a member of our Legal Team.

    Thanks for watching. If you still have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here’s to the success of your healthcare venture, from all of us, we look forward to speaking with you.


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