In the United States, herbal supplements, essential oil supplements, and nutraceuticals fall under the FDA umbrella classification of dietary supplements. Dietary supplements, according to the FDA, are products which are meant to be taken internally to "affect the normal structure or function of the human body." This designation opens the door to a highly lucrative type of product claim: the structure / function claim.
The concept of structure / function refers to the body as a whole. Unlike pharmaceuticals, dietary supplements (herbal products, essential oils, nutraceuticals) maintain the body in this state of normal health. In short, pharmaceuticals treat and cure, whereas natural supplements maintain and support.
Structure / function claims describe the role in which a product or formulation affects the normal structure or function of the human body, unrelated to disease or dysfunction. These include claims such as “supports the immune system,” or “helps maintain regularity,” or even “promotes relaxation.” You’ve likely seen these claims on everything from vitamins to herbal remedies to essential oil products in your local health food store.
These are not drug claims (i.e. claims to diagnose, prevent, treat, or cure a condition), so they don't require a company to go through the FDA drug authorization process. But that doesn't mean these claims are not subject to both FDA and FTC oversight. Adding these claims to your website, product labeling, or marketing materials without following the steps below leaves your brand vulnerable to regulatory actions which can involve significant fines and reputation-destroying correction letters.
To legally make a structure / function claim, three key criteria must be met.
1. Claim Substantiation.
Before you can lawfully make a claim about your product’s effects on the human body, you have to compile “competent and reliable scientific evidence,” which the FTC defines as including: "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."
In other words, it is not enough to have a collection of pubmed citations or textbook articles. This is insufficient to substantiate a claim; each component of your specific claim and your specific product must be assessed by “persons qualified to do so,” i.e. scientific researchers. This information must be available should it be requested by oversight agencies. A good rule of thumb is to have it accessible within 15 minutes.
This substantiation typically requires clinical trials on your specific product within your specific target population. In some instances, there may be sufficient evidence already in the scientific literature to substantiate your claim without running a clinical trial. Our team can help you evaluate the current science to determine what you will need in order to make structure / function claims for your product.
2. Thirty-Day Notification
Once you have a professionally-reviewed substantiation dossier, the new claims, taglines, images, or other marketing strategies are ready to go. However, you must notify the FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements within 30 days. If our team compiles or reviews your dossier, we walk you through this process.
The notification letter requires signatures by the responsible party indicating that the company has prepared a substantiation file which was either compiled or reviewed by a qualified scientist and that sufficient levels of evidence exist to support the claim. Without this confirmation, both the FDA and the FTC have the authority to penalize or take further legal action against companies which do not have sufficient substantiation for claims they make.
3. FDA Disclaimer.
When the FDA receives this notification, it is processed and filed. However, it is not evaluated and approved. This is a key distinction. Because the FDA does not provide explicit approval for these claims, the dietary supplement disclaimer must be included on your marketing in the correct size, font, and location. “This claim has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
This FDA disclaimer is a source of substantial confusion in natural products marketing. Many marketing teams mistake this disclaimer as being useful for any natural product placed on the market. However, the claim is only beneficial within the context of the dietary supplement structure / function claim process. Without also conducting original research, substantiating a claim, and submitting notice, this claim on its own will not protect your brand from regulatory action.
What's at Stake?
Despite the simplicity of these regulations, many brands in the natural products industry violate these guidelines and make either direct or implied structure / function claims without the correct scientific substantiation dossiers and/or without FDA notification. They are quite literally banking on staying too small to be noticed. However, direct violations of both FDA and FTC requirements in the hopes of going unnoticed is a dangerous business strategy.
Both agencies can–and do–conduct follow-up and companies which do not have sufficient evidence can face FDA warning letters or FTC regulatory actions. These can be extremely damaging as the public notices create negative publicity and can ultimately result on the loss of consumers, competitive advantages, or the brand as a whole.
Properly substantiating your claim in the natural products industry not only protects you from FDA and FTC regulatory actions; it also builds trust with your customer base, demonstrates your brand's integrity, and ultimately, ensures that your products are the best on the market. The market share and competitive advantage offered by properly substantiated claims is well worth the small investment.