Presenting Supplement Info to Customers...Responsibly

Retailers must be aware of the federal and state regulations covering the sale of dietary supplements, and avoid making drug claims or providing medical advice.

It is critical that individuals engaged in the practice of recommending and/or selling dietary supplements avoid making claims that a dietary supplement can be used to prevent, treat or mitigate a disease or medical condition. This is the definition of a drug; any statements to this effect will cause the supplement to be considered an unapproved drug by the Food and Drug Administration (FDA).

One of the first considerations is to avoid diagnosing, which is the purview of licensed health care providers. It is surprising how easily a conversation with a customer can become a diagnosis. If a customer discusses how she has low energy levels and headaches, the appropriate response is not: “it sounds like you have hypoglycemia” (a medical condition), but perhaps “with those issues, it is important to maintain healthy blood sugar levels.” While the same products—probably chromium and protein drinks during the day—could address the issue, the second discussion avoids diagnosing a medical condition. In addition, it is good to add, “You may wish to see your doctor and ask about a glucose tolerance test, in case you have blood sugar problem such as hypoglycemia.”

The next issue is prescribing products, which is—again—the domain of health care providers and pharmacists. There is a fine line between recommending and prescribing. For example, it is inappropriate to tell a customer, “This product contains glucosamine sulfate, which may help to reduce your arthritis pain.” It is appropriate to state, “This product contains glucosamine sulfate, which provides you with support for the repair and maintenance of healthy joints.”

Essentially, there are two types of claims that may be made in association with a dietary supplement. Health Claims are approved by the Food and Drug Administration (FDA) under the Nutrition Labeling and Education Act (NLEA). Those associated with dietary supplements include the link between calcium/bones, folic acid/neural tube defects and soy protein/coronary heart disease.

The other type of claim is a Structure/Function Claim, which are claims made about the role of a nutrient, herb or other dietary supplement ingredient with regard to a structure or function in the human body. The Dietary Supplement Health & Education Act (DSHEA) of 1994 allows these claims in association with dietary supplement products. A structure/function claim might state: “Creatine may help you achieve greater muscle growth.”

This is not to say that the possibilities for discussing nutrition and health are limited. In fact, there is a broad spectrum of nutritional facts and information that can be discussed, including deficiency levels of nutrients; the physiological functions of nutritional supplements within the body; and daily values versus optimum nutrition.

In addition, DSHEA protected the avenue of third-party literature, whereby publications written by third parties about the health benefits of dietary supplements may be distributed in connection with the sale of supplement products. Significantly, third party literature can lawfully discuss the role of dietary supplements in preventing or treating diseases, without subjecting the supplements to regulation by FDA as drugs. The obvious advantage to third-party literature is that it can present health benefit information beyond structure/function claims, particularly statements about how a given dietary supplement can be useful in the prevention or treatment of some disease condition.

There is a further consideration, the interaction between literature and labeling. If a piece of literature is placed next to a dietary supplement, the literature is then considered to become part of the supplement’s label. This is known as extension of labeling. Extension of labeling may be okay as long as certain criteria are met. First, the literature should not be third-party literature. Second, it must only use structure/function claims in describing the product.

An example of legal extension of labeling would be placing a brochure about XYZ products (which uses only structure/function claims) on the shelf next to the actual XYZ products. An example of illegal extension of labeling is a photocopy of third party literature which talks about cat’s claw and cancer, placed next to cat’s claw products. From a legal standpoint, this would identify cat’s claw as an unapproved anti-cancer drug.

There are some questions of philosophy regarding the kinds of conversations we want to have with customers. Above all else, we respect and care about our customers and their needs. Because we want to serve as a source of information about nutrition for our community, we should work hard to provide credible information and to recommend further reading to customers. Many customers rely on the information they receive from us in making decisions about their diet and their health, so we have a serious legal and ethical responsibility not to provide information that is uncertain, misleading or controversial.

In the field of nutrition, there can be a real difference between what you believe to be true and what is generally accepted as true. There is a clear difference between the statement of a physiological fact and the assertion that supplementation with that nutrient will trigger a physiological change for a specific customer.

Furthermore, there is an equally clear difference between talking about the benefits of supplementation as a part of a healthy lifestyle and making the claim that a supplement will cause a specific response in one of your customers. Although it may not always seem to be black and white, these differences define the line between what we do say and what we don’t say in conversations with our customers.

• We do know what is widely accepted among responsible nutritional authorities.
• We do talk about both sides of issues where there is disagreement among authorities.
• We do talk about the basic benefits of products as nutritional support factors when used as part of a healthy diet and exercise program.
• We do talk about the functions of nutrients that are known to be involved in supporting the normal functioning of the body’s systems.
• We do not rely on opinions that contradict what is widely accepted among responsible authorities.
• We do not assert that supplementation with these nutrients will correct the abnormal functioning of the body’s systems.

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