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We all know that it is essential to sell the benefits in order to sell the products. We must make a connection for new prospects between health benefits and our health products, but in doing so we must work within the regulatory guidelines. As a dietary supplement company, we are obligated to follow the regulations of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Because our products do not go through rigorous FDA testing and protocols that drugs must undergo, we are not allowed to make specific health claims. We can talk about the positive effects of our products and we can make nutritional statements for the support of the structure or function of the body, but we must do so in a compliant way. Basically, statements are compliant if they follow the DSHEA disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
One way to make sure that the promotional statements you want to use are compliant is to run the abnormality test. You perform the abnormality test for advertising material by taking a statement and trying to ascertain whether or not the statement implies a pre-existing condition. For example, "may help to normalize blood pressure…" implies that the product is going to correct a pre-existing condition (high or low blood pressure), and this would be considered a drug claim. By rephrasing the statement to read "may help to maintain a normal blood pressure level where levels are already normal" implies that a normal blood pressure level pre-existed and that the product's purpose is to help maintain that state of well-being. This qualifies as an appropriate structure/function statement. A good tip in checking your statements for compliance is to watch for words that have antonyms that imply an abnormal condition. For example, "control" implies a condition that was uncontrolled or out-of-control (e.g., blood pressure is now under control); "balance" implies an unbalanced condition; "remedy" implies the presence of disease; "mend" implies that an organ or body part may have been damaged or hurt; "stabilize" implies a condition that was unstable; "cure" implies the presence of disease; "heal" implies a damaged, injured, or infected condition. Let's take a look at how one statement might be written three different ways: Lowers cholesterol - an explicit disease claim. This is explicit because the condition is going from an abnormal state to a normal one. Helps maintain cholesterol levels - an implied disease claim. You would think that this example would be all right because it says "maintain cholesterol levels," but unless the levels are in a normal range to begin with, this statement could be interpreted as describing a drug that maintains healthy cholesterol. Helps maintain cholesterol levels that are already within the normal range - a permissible structure/function claim. This is the correct way to make this statement. It is acceptable to say that a product helps to maintain levels that are already normal. Examples of express disease claims:
Examples of implied disease claims:
Examples of permissible structure/function claims:
We're often asked if it is acceptable for a medical professional to make disease claims. The answer is no. If a dietary supplement is being promoted as a treatment, cure, or preventative for a disease, then the regulations of DSHEA are being violated, no matter who is making the claims. In fact, we recently learned that even if you share a personal experience and are convinced that our products were responsible for improvements with a "condition" of any sort, the company is technically liable! Of course we don't expect to have the FDA follow our customers around to monitor this type of sharing, but it is important that you are aware of the legalities. Our customers in Canada have even more stringent requirements. Technically they are not permitted to share any information about our products beyond the basic information included on a label. We cannot include any product literature in Canadian packages, and the business opportunity should not be promoted in Canada. We operate under the Personal Use Guidelines-products are shipped directly to the end consumer, in limited quantities. A document outlining the quantities allowed in Canada is posted online when a Canadian customer logs in. Simplexity Health has an advertising policy in place to protect the company and our Business Associates. If we follow our policy we will not violate government regulations, and the business opportunity will be protected for all. |
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