Dietary Supplements: What you need to know.
Are you selling or marketing dietary supplements? You may be surprised!
The phrase dietary supplement is often thought to refer to weight loss products, multivitamins, mineral supplements, and the like. The legal classification, however, is far more broad… and includes the overwhelming majority of natural products.
Yes, a dietary supplement can be a vitamin, mineral, amino acid, or the like. It can also be an herb or botanical, a plant extract, an essential oil, a nutraceutical, or even a combination of natural ingredients. Essentially, anything that is meant to be ingested and is not part of a conventional meal or food replacement is a dietary supplement as far as the FDA and FTC are concerned.
Elderberry syrup? Garlic capsules? Slippery elm bark lozenges? Essential oil cough drops? Cranberry powders? Echinacea gummies? All dietary supplements. Herbal supplements are dietary supplements. Essential oil supplements are dietary supplements. Nutraceuticals are dietary supplements.
Dietary supplements are orally administered. So lotions, creams, balms, and salves don’t fall into this classification. Similarly, they cannot contain drugs such as aspirin, and they cannot be conventional foods, such as meal shakes or replacements. Most importantly, dietary supplements don't claim to diagnose, treat, or cure a disease.
Dietary Supplements are regulated by the FDA (Food and Drug Agency) and the FTC (Federal Trade Commission). These two agencies work together with an end goal of ensuring that consumers have “accurate information about dietary supplements so that they can make informed decisions about these products.” - FTC guidance documents
Anyone promoting dietary supplements is required to be familiar with these guidelines. It does not matter if you are the owner of the company, a sales representative, a blogger sales affiliate, or a marketing employee. “Anyone who participates directly or indirectly in the marketing of dietary supplements” must know and adhere to the guidelines for marketing dietary supplements.
Dietary supplements are not investigated by the FDA prior to entering the market. They do not require you to apply for authorization or to submit evidence of the safety or efficacy of your products. They do, however, require you to obtain claim substantiation before making any claims about the product’s effects on the body. Any claim, whether express or implied, requires a complete scientific dossier substantiating its accuracy. These claims must also be registered with the FDA before they are used. There is no charge for registering dietary supplement claims, but failure to adhere to these guidelines can be costly.
Violate the dietary supplement claims guidelines and you will hear from the FDA, the FTC, or both. Failure to follow these guidelines places your brand at risk of corrective actions ranging from public and embarrassing FDA warning letters to multi-million dollar FTC settlements. Your brand may suffer from negative publicity due to these regulatory actions, significant financial penalties, a loss of market share, and loss of any competitive advantage you have earned.
Your brand may be at risk not only from the unauthorized use of drug claims, but also from the failure to properly substantiate non-drug related claims (i.e. health claims, structure-function claims, etc). As a general rule, any claim you make anywhere in your marketing for a dietary supplement should have comprehensive substantiation. This is not merely a collection of study references in a file; substantiation must include “competent and reliable scientific evidence” which has been compiled and interpreted by “persons qualified to do so.”
Our team specializes in claim substantiation for the natural products industry. And where claims cannot be substantiated, our team can suggest alternative claims that do meet this guideline or conduct additional research necessary to substantiate a claim.
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.