Can a dietary supplement company link to scientific references that show that that the dietary supplement product is effective in treating a disease such as cancer, diabetes, or hypertension? This is question many dietary supplement clients ask. Let’s look at some relevant FDA and FTC law.
FDA Can Take Enforcement Action Based on Dietary Supplement Claims, Testimonials or Scientific References
The short answer is that this is a legally risky practice.
When you are marketing a dietary supplement, FDA can throw the enforcement hammer based on your claims, testimonials, or scientific references.
Here’s some advice for lowering FDA enforcement risk.
Information Site vs. Product Site
Let’s suppose you have two dietary supplement sites: a product site, and an information site.
The product site features dietary supplement products you sell, plus links for customers to purchase these products. The information site features educational information about various dietary supplements. Can you link the two?
Structure/Function Claims vs. Disease Claims
Dietary supplement companies can make structure/function claims for dietary supplement products.
Dietary supplement companies cannot make drug claims (or disease claims) about their products. For example, a dietary supplement company cannot call its Noni Juice product, “Noni Anti-Cancer Juice.” Putting the name of a disease (cancer, hypertension, diabetes, anxiety, insomnia, etc.) in the product name is a very obvious way to make a prohibited disease claim. In such case, FDA will classify the dietary supplement as a “drug.” And under the federal Food, Drug & Cosmetic Act, unapproved new drugs cannot be introduced into interstate commerce.
A disclaimer to the consumer will not cure the legal and regulatory violation of a disease claim for a dietary supplement. FDA will blow right past any disclaimer.
Under federal law, all appended material—including website(s) promoting the product—can be considered part of the “labeling” for the product.
So when you link your product site to your information site, or the reverse, both sides are included in what FDA considers the dietary supplement product labeling.
Another way to think of this is through the “intended use” doctrine. If you have a product webpage that links to an informational site where the informational site contains claims, or scientific references, or testimonials, about the product’s effectiveness in connection with diagnosing, preventing, treating, curing, or mitigating a disease, then FDA will consider this to be a disease claim for your product.
Intermediate Site Strategy
Some companies have an “intermediate” site between the product and information page, letting the user (or customer) know that they are leaving one site or page and entering another. The intermediate page will have a disclaimer with respect to any disease claims.
Regarding this strategy, FDA has never formally adopted a “two-click rule”—i.e., FDA has never said that it will not undertake enforcement action, simply because a web page that makes prohibited, disease claims is “two mouse clicks” away from a page that contains a link to purchase the product.
The truth is that disease claims will make the product subject to drug regulation. Only structure/functions should be made.
This means that any scientific literature should, ideally, only support structure/function claims. If the scientific literature mentions a disease or therapeutic approach, then FDA can make the case that the manufacturer or distributor is making a disease / drug claim for the dietary supplement product.
So what can dietary supplement companies do?
We’ve already mentioned the intermediate page strategy; it’s not guaranteed, but is an attempt to try to create some distance between the disease reference, and the product itself.
Two additional FDA enforcement risk mitigation strategies are:
- Present a balanced view of the scientific literature. A balanced view means both supporting and contrary articles. This is to try to take advance of the “third-party literature” exception under DSHEA.
- Provide qualifying language regarding the scientific literature, in which you explain how the literature supports a proper structure/function claims.
Again, these strategies are intended to mitigate risk, but of course, no one can guarantee complete freedom from FDA enforcement.
One more caution, and that is that in addition to looking at express claims on the dietary supplement product website, as well as links to testimonials and scientific references, FDA has also taken the position that even when a dietary supplement company (or one of its officers) “LIKES” a therapeutic (disease) claim or testimonial, this is the same as if the dietary supplement company itself made the claim.
So don’t LIKE your customers’ disease-claim testimonials for your dietary supplement product.
In an FDA review, substantiation is also important. Dietary supplement companies should have their FDA lawyers look at claims, labels, and substantiation.
FDA and FTC share the same substantiation standard, which is that claims about the safety or efficacy of dietary supplement must be supported by “competent and reliable scientific evidence.”
FDA and FTC will generally require at least one randomized, placebo-controlled human clinical trial of high methodological quality.
So, will FDA Act if You Link Dietary Supplement Claims to Testimonials or Scientific References? Probably so.
FDA law is a maze of regulation. Among other things, it’s helpful to review FDA warning letters before making claims regarding your dietary supplement product.
Even if distribution is very small, or even intrastate, FDA can still find ways to exert jurisdiction. FDA is about consumer protection, and that can include searching the Internet for terms (for example, “noni juice” and “cancer”) to see whether a particular kind of dietary supplement is being associated by its manufacturers or distributors with any given disease claim.
Someone else coined the term “epistemological chaos,” and I like this term. Maybe it reminds me of my college philosophy class when I actually studied epistemology and regularly used “SAT vocabulary words” to impress my friends (or because I actually knew them … before the advent videos dulled our societal level of articulateness).
The reality is that there is an epistemological slippery slope, if you will, between claims about wellness and claims about disease. These are Yin and Yang, flip sides of the same coin. There’s one human in between.
So for example, it is an acceptable structure/function claim to say, “helps you fall asleep,” but an unacceptable disease claim to say, “helps you fall asleep if you have difficulty falling asleep” (because that is a claim for insomnia). Puzzling but true: this is how FDA draws the line.
Some day we will better understand—and accept—the contiguous surface between health and its opposite; especially as mind-body-medicine, holistic thinking, systems paradigms, and integrative healthcare gain greater ascendancy.
In the meanwhile, there is still a legal dividing line between the practice of “medicine” and everything else; and between therapeutic, disease-oriented claims, and the claims of general well-being (or structure/function claims) that are acceptable domains for dietary supplement promoters.
Epistemological chaos reigns while regulation has imposed its own order on industry.
That’s where a consult is advisable, with a savvy FDA and FTC lawyer who can vet your dietary supplement claims for regulatory compliance, and create a legal strategy for the regulatory path to market.