You need to understand the Dietary Supplement Health and Education Act of 1994 (DSHEA) if your business markets any of the following dietary supplements, …
- amino acids,
- herbs or other botanicals,
- dietary substances to supplement the diet through total dietary intake,
- or concentrates, metabolites, constituents, extracts, of any combination of any of the above ingredients.
Marketing a dietary supplement, whether with a pamphlet, web page, newspaper ad, email, blog, or social media post, requires that you assure that all of your written content complies with DSHEA. The Act provides a regulatory framework for your products, and, it’s the primary regulation that you should get to know to assure that you have Food and Drug Administration compliant (FDA compliant) marketing content.
DSHEA’s a Tough Pill to Swallow
Through the Act, Congress solidifies its recognition of dietary supplements’ capacity to promote health and prevent chronic diseases. However, like all legal documents, it’s legal lingo, formality, and comprehensive nature make it a tough pill to swallow. DSHEA and its supporting documents have become cumbersome and intimidating to businesses that wish to create content to market and promote their dietary supplement products. Since the enactment of the DSHEA, the FDA and other organizations have, in their well-meaning efforts to clarify and disseminate information about DSHEA, withdrawn or modified some guidance, made declarations; published proposals; issued statements and rulings; and published many other documents (see, for example, Commission on Dietary Supplement Labels 1997) that, although in support of DSHEA and associated regulation, amount to too much information to read and learn without a concerted effort and investment in time.
Your marketing content, whether it’s email, web pages, pamphlets, or Facebook or blog posts, must comply with the DSHEA criteria. For example, despite a large body of scientific literature evaluating different dietary supplements to prevent chronic diseases, like diabetes, cardiovascular diseases, cancer, osteoporosis, and arthritis, your marketing content cannot include phrases like “cures diabetes,” “promotes recovery from injuries,” or “helps you get over colds and flu faster.”
“in an era of greater consciousness among people about the impact of what they eat on how they live and how long they live, it is appropriate that we have finally reformed the way Government treats consumers and supplements in a way that encourages good health.”
The Act does encourage the dissemination of health benefits of dietary supplements, while assuring that manufacturers, retailers, and marketers carefully choose the language by which they describe and promote their products. As a marketer, if you take some time to read DSHEA, you’ll see that it does, indeed, define what you can say about your dietary supplements as part of your marketing. However, after reading the document, you may also feel that you’re not really sure how to interpret Congress’ words.
If you don’t understand all of it, consider yourself normal. The document, according to the Flesch–Kincaid readability test (Flesch 1948, Farr 1951), which estimates the difficulty of an English passage, scores the DSHEA at 50.5. Technically, that means that it’s, “fairly difficult to read,” with 50.5 falling half a point away from being “difficult to read” (as determined on Readability.com 2011 – 2016).
Marketing Dietary Supplements Like Foods
According to DSHEA, the law sees dietary supplements as a class of foods, rather than drugs. Foods, unlike drugs, do not require screening for safety and effectiveness prior to marketing them. DSHEA holds the FDA responsible for determining whether or not foods are harmful, and so it is with dietary supplements.
Content Containing Disease Claims Requires Prior FDA Approval
“The FD&C Act defines drugs, in part, by their intended use, as ‘articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease’ and ‘articles (other than food) intended to affect the structure or any function of the body of man or other animals’ [FD&C Act, sec. 201(g)(1)].” (Food and Drug Administration 2016).
Marketers of dietary supplements may not make disease claims without prior FDA approval. The Administration, together with the Federal Trade Commission (FTC), by October 19, 2006, had issued “approximately 180 warning letters and other advisories …to online outlets in the three countries,” that had made fraudulent claims about dietary supplements as diabetes cures and treatments measures (Food and Drug Administration 2006).
The FDA, upon detecting non-compliant DSHEA marketing content may issue a warning letter to the entity marketing the product. For example, in 2008 it issued a warning letter to A1 Discount Vitamins. The letter warned the retailer that its marketing content about its Graviola product contained non-compliant statements, including the following:
“Graviola … Can Help Prevent and Fight Cancer!”
“Graviola Cancer Fighting Herb From South America!”
“Graviola, … helping millions of people fight through their cancer treatment.”
“Can help kill cancer cells!”
“Can help slow tumor growth!”
“… effective in killing tumors that have resistance to anticancer agents…”
Graviola is effective against all types of cancer, and is a broad spectrum anti-microbial for bacterial and fungal infections, internal parasites, and worms.”
“Graviola main uses: 1. Cancer (all types).”
“CONQUER CANCER SAFELY and effectively …”
Although the effects of Graviola against cancer cells has been studied scientifically (for example, Chen et al. 2012a, 2012b; Cetina-Dorantes et al. 2016), the FDA has not authorized disease claims like those made by A1 Discount Vitamins, and it warned A1 Discount Vitamins that …
“The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.”
The FDA considers that “a statement also is a disease claim if it implies that it has an effect on a specific disease or class of diseases by using descriptions of the disease state.” It provides a number of examples of implied disease claims:
- “relieves crushing chest pain (angina),
- “improves joint mobility and reduces inflammation (rheumatoid arthritis),” and
- “relief of bronchospasm (asthma) (Food and Drug Administration 2002a).
The FDA released, just this year, more than 200 warning letters companies marketing products on Facebook, for example. Eleven specifically targeted dietary supplement retailers.
You May Market “Structure/Function” Claims without Prior FDA Approval
The FDA (2002a) does allow marketing content for dietary supplements to make what it calls, “Structure/Function Claims,” which it defines as…
“… statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims.”
In its “Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, Final Rule,” the FDA (2000b) discusses, in detail, why it considers the phrase, “maintains healthy cholesterol levels,” an allowable structure/function claim. It responded to arguments posed by an unnamed food industry group and an organization devoted to the prevention and treatment of heart disease:
“The FDA does not agree that claims concerning maintenance of normal cholesterol levels necessarily constitute implied disease claims. Although an elevated cholesterol level is a sign of hypercholesterolemia and an important risk factor for heart disease, a cholesterol level within the normal range is not a sign or risk factor for disease. Moreover, maintaining cholesterol levels within the normal range is essential to the structure and function of the body for reasons other than prevention of heart disease… Normal cholesterol levels play a positive role in maintaining a healthy body. Cholesterol is a necessary constituent of cell membranes and of myelin, the sheath that coats nerves. Cholesterol is also required for the synthesis of steroid hormones, which are essential for life. Finally, cholesterol is required for the production of bile in the liver, making possible absorption of dietary fat and fat soluble vitamins. Thus, a claim that a dietary supplement helps maintain cholesterol levels that are already within the normal range does not necessarily imply disease.”
Other acceptable structure/function claims specifically listed by the FDA (2000b) include,
“Maintains healthy lung function,”
“helps to maintain cholesterol levels that are already within the normal range,”
“supports a normal, healthy attitude during PMS,”
“supportive for menopausal women,”
“arouses or increases sexual desire and improves sexual performance,”
“supports the immune system,” and
“helps maintain intestinal flora.”
Such structure/function claims, according to the FDA are not disease claims and are, therefore, acceptable phrases to use when marketing dietary supplements.
Supplements are generally regulated as foods, but a supplement bearing a disease claim will be regulated as a drug (unless the claim is an authorized health claim for which the product qualifies).
If you’re involved in marketing dietary supplements, be sure to familiarize yourself with DSHEA and related legislation. Check out the FDA’s website, pages cited in this blog post (see links below, in the “References Cited” section), and, if necessary, work with an expert to assure that your marketing materials, whether on Facebook, Twitter, Google+, a blog, your website, or traditional paper publications meets DSHEA standards. Make sure that your content goes live with DSHEA compliant text, and you’ll save yourself money and headaches while getting your marketing material in front of your target audience.
Cetina-Dorantes, A. J. V. Arana-Argaez, J. Torres-Romero, J. Canul-Canche, and M. Ramirez-Camacho. 2016. Effect of methanolic extract of Annona muricta leaves on macrophage effector functions. The Journal of Immunology 196 (1), on The Journal of Immunology website (http://www.jimmunol.org/content/196/1_Supplement/69.25.short), Reviewed 5 September 2016.
Chen, Y., S. S. Xu, J. W. Chen, Y. Wang, H. Q. Xu, N. B. Fan, X. Li. 2012a. Anti-tumor activity of Annona squamosa seeds extract containing annonaceous acetogenin. compounds. J Ethnopharmacol. 142(2): 462 – 6.
Chen, Y., J. W. Chen, S. S. Xu, Y. Wang, X. Li, B. C. Cai, N. B. Fan. 2012b. Antitumor activity of annonaceous acetogenins in HepS and S180 xenografts bearing mice. Bioorg Med Chem Lett.22(8):2717-9.
Clinton, W.J. 1994. Statement on Signing the Dietary Supplement Health and Education Act of 1994. The American Presidency Project (http://www.presidency.ucsb.edu/ws/?pid=49370), Reviewed 3 September 2016.
Commission on Dietary Supplement Labels. 1997. Regulations Related to Dietary Supplements Since Passage of DSHEA, in the Final Report Transmitted November 24, 1997 by the Commission on Dietary Supplement Labels.The Office of Disease Prevention and Health Promotion (https://health.gov/dietsupp/table1.htm), Reviewed 4 September 2016.
Congress of the United States of America. 1938. Federal Food, Drug, and Cosmetic Act (FD&C Act). Public law 75-717, Statutes at Large 52 Stat.1040, Enacted by the 75th United States Congress. Available on the FDA’s website (http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm), Reviewed 8 September 2016.
Congress of the United States of America. 1994. Dietary Supplement Health and Education Act of 1994 (DSHEA). Public Law 103-417, 103rd Congress of the United States of America. Available on the National Institutes of Health, Office of Dietary Supplements website (https://ods.od.nih.gov/About/DSHEA_Wording.aspx), Reviewed 4 September 2016.
Flesch, R. 1948. A new readability yardstick. Journal of Applied Psychology. 32: 221–233.
Farr J. N., J. J. Jenkins J.J., and D. G. Paterson. 1951. Simplification of Flesch Reading Ease Formula. Journal of Applied Psychology. 35 (5): 333–337.
Food and Drug Administration. 2000. Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, Final Rule. 21 CFR Part 101, [Docket No. 98N–0044], RIN 0910–AB97. Department of Health and Human Services, Food and Drug Administration. Federal Register 65(4): 1000-1050, as viewed on the United States Government Publishing Office website (https://www.gpo.gov/fdsys/pkg/FR-2000-01-06/pdf/00-53.pdf), Reviewed 4 September 2016.
Food and Drug Administration. 2002a. Guidance for Industry: Structure/Function Claims, Small Entity Compliance Guide. Food and Drug Administration website (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm103340.htm), Reviewed 5 September 2016.
Food and Drug Administration. 2002b. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). Food and Drug Administration website (http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm), Reviewed 5 September 2016.
Food and Drug Administration. 2006. FTC and FDA Act Against Internet Vendors of Fraudulent Diabetes Cures and Treatments Measures are Part of Coordinated Effort by United States, Mexico and Canada. FDA News Release on the FDA website (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108772.htm), Reviewed 5 September 2016.
Food and Drug Administration. 2008. September 11, 2008 Warning Letter 2008-DAL-WL-22 to AI [sic] Discount Vitamins. On the FDA’S website, under “Inspections, Compliance, Enforcement, and Criminal Investigations” (http://www.fda.gov/iceci/enforcementactions/warningletters/2008/ucm1048135.htm), Reviewed 5 September 2016.
Readability.com. 2011 – 2016. Measure Text Readability. On Readability.com’s website (http://beta.readability-score.com/text/), Reviewed 4 September 2016.