In the United States, natural supplements which are made from herbs, essential oils, and other botanical ingredients and are meant to be taken internally are regulated as foods, and are officially classified as dietary supplements. These internal-use natural products enjoy unique legal access to make structure / function claims.
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 products like 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.
Because these are not drug claims (i.e. claims to diagnose, prevent, treat, or cure a condition), they are still 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 references 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.
Our team specializes in the compilation of claims dossiers for the natural products industry.
Many smaller companies compile the starting evidence for a substantiation dossier on their own, then hire a research firm to review the evidence and provide a professional summary of their findings; others prefer to have the entire dossier put together. Whichever approach you choose, the critical ingredient for your dossier is interpretation by scientific professionals who can confirm that the dossier reflects the entirety of the available scientific evidence.
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.
Note, pre-market approval is not required; the FDA does not review the evidence and approve structure / function claims. However, 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.
This disclaimer must be included on your marketing: “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.” (Note: additional guidelines exist regarding the placement and font size of the disclaimer.)
This creates an abundance of confusion in the natural products market. Many people incorrectly assume the FDA disclaimer is only for companies that have not completed steps 1 and 2, that it exists as an alternative of sorts. After all, if you’ve substantiated your claim, paid for professional assessment, potentially paid for the original clinical research, and submitted the documents to the FDA, why do you need to also include disclaimers? Because, as outlined above, the FDA does not evaluate and approve your structure / function claims. You've sworn that you possess this evidence and they've taken your word for it.
There is no alternative to steps 1 and 2, aside from complete avoidance of claims regarding how a product can affect the human body.
What's at Stake?
Despite the simplicity of these regulations, many businesses in the natural products industry violate these guidelines and make direct or implied structure / function claims without professionally compiled or reviewed dossiers and 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.
Meet Dr Hawkins
Dr. Hawkins brings 20 years of expertise in the integrative health field to her role as Executive Director of the Franklin School of Integrative Health Sciences and the leader of our clinical research team.
She holds a Bachelor’s Degree in Environmental Health from Union Institute and University, a Master’s Degree in Health Education & Promotion from the University of Alabama, a post-graduate certificate in epidemiology from the London School of Hygiene and Tropical Medicine, a PhD in Health Research from Middle Tennessee State University, and is completing the post-doctoral Global Scholars Research Training Program at Harvard Medical School. She also holds certifications in numerous natural health fields including aromatherapy, aromatic medicine, herbalism, childbirth education, and labor support.