The Dietary Supplement Health Education Act (DSHEA) of 1994 are federal regulations governing the manufacturing and marketing of dietary supplements, which includes most vitamin retailers. For example, if a retailer sells private label supplements they are responsible for assuring the finished products meet current Good Manufacturing Practices (cGMPs), and that the labels and collateral materials abide by the legislation.
Although, when it comes to DSHEA, not all retailers are in the same category. “For the most part, DSHEA does not apply to retailers who passively place a product on the shelf; it only applies if a retailer actively advertises and promotes a claim that turns out to be false or misleading. This is a key principle to understand,” said Roy Upton, RH, DipAyu, Director, Planetary Herbals and Executive Director, of the American Herbal Pharmacopoeia. However, Upton added that, “despite this, we have seen State Attorneys Generals take action against mainstream retailers for selling products that were allegedly not GMP-compliant. So while DSHEA generally does not apply to retailers, retailers still have a level of responsibility regarding compliance for the brands they sell and the claims made; this is especially relevant for retailers with private labels. While FDA may not consider non-manufacturing retailers a regulatory priority, Attorneys Generals may”.
For retailers that do interact with customers and speak with them about their health concerns and supplement options, the, law itself does not apply, but principles regarding the law, such as information regarding claims, do.
Regarding label and marketing laws, because dietary supplements are not classified as drugs, supplement labels and collateral materials cannot include information implying that they treat, cure or mitigate disease. Conversely, supplements are a sub-category of “foods” and can make structure/function claims. These types of claims illustrate how a supplement can support the normal, healthy structure or function of the body. Moreover, DSHEA specifically allows retailers to provide customers with information about the potential therapeutic benefits of supplements “as long as the information reflects the totality of the available information, is ‘balanced’, does not promote a specific brand, and is truthful and not misleading.” The amount of information a retailer chooses to disseminate either in writing or orally is guided by the amount of risk the business wants to incur.
Some of the same restrictions that apply to dietary supplement labels and marketing also apply to vitamin retail staff. When speaking to customers about their health care concerns and dietary supplement usage, employees would do best to stick with structure/function language.
For instance, we can say ginkgo may improve memory or maintain health blood vessel tone, but we can’t say it can prevent, treat, or cure dementia or varicose veins. We can say glucosamine may help promote healthy joint function. And we can mention that it’s an essential structural component of the glycosaminoglycans, the building blocks that help lubricate joints, nourish cartilage and connective tissue. But we can’t say that it’s a prevention, treatment or cure for pain or arthritis.
Beyond structure/function claims, there is another type of claim that can be used and those are called “Qualified Health Claims.” These are FDA pre-approved health claims including:
- “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors”
- “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease”.
A complete list of qualified health claims can be found on the FDA’s website (http://www.fda.gov/default.htm)
If this wasn’t already confusing enough, there are instances wherein you can talk more freely with customers about, “health conditions that are part of the normal living or aging process such as menopause, morning sickness, mild memory loss and PMS. These are not considered diseases….,” said Mr. Upton.
But how do you differentiate between a health condition that is “part of normal living”, and one that is not normal? “Health conditions that are an occasional part of normal life such as occasional constipation, occasional anxiety, occasional sleeplessness, occasional GI upset, occasional nausea, and occasional pain, are not considered drug claims as long as the symptoms are characterized as occasional. Again, these can be readily discussed and products provided, but both the retailer and customer must be clear that the line between health promotion and disease treatment has not been crossed,” added Mr. Upton.
Another area where staff can more freely speak with customers is when talking about common health conditions that can be attributed to nutrient deficiencies, backed by substantial scientific and expert validation. The link between scurvy and vitamin C, calcium and bone health, and vitamin D and rickets, are just a few examples of these types of nutrient-disease correlations.
One of the best things a retailer can do to protect themselves and their customers is to know the federal and the state regulations. Implement a store policy and educate staff on the legal requirements and structure/function conversations. Also, beyond supplying branded marketing materials and literature, many retailers find it beneficial to have a reference library, as long as the sources are authoritative and unbiased. And, as long as it’s not implied that the literature supports a particular product or treatment of a health condition.
Julie Dennis has been a lecturer, writer and consultant in the natural products industry for over 20 years. Currently she lectures nationwide discussing health-related topics and intelligent usage of nutraceutical and botanical supplements. She graduated from Dr. Michael Tierra’s East West School of Herbology in 1996, contributed to major natural products industry trade publications, and assisted with editing on books including the American Botanical Council’s Clinical Guide to Herbs, and The Handbook of Clinically Tested Herbal Products, Haworth Press.
NOTE: The statements presented in this blog should not be considered medical advice or a way to diagnose or treat any disease or illness. Dietary supplements do not treat, cure or prevent any disease. Always seek the advice of a medical professional before adding a dietary supplement to (or removing one from) your daily regimen. WholeFoods Magazine does not endorse any specific brand or product. The opinions expressed in bylined articles are not necessarily those of the publisher.
Posted on WholeFoods Magazine Online, 9/26/2016