Drug manufacturers can make claims that their products will diagnose, cure, mitigate, treat, or prevent a disease. However, such statements are not legally allowed in relation to dietary supplements. Statements about diseases or health properties demonstrate a connection between a food or substance and a health-related disease or condition. An example of this type of statement would be calcium and a lower risk of osteoporosis if a supplement contains sufficient amounts of calcium.
Statements about nutrient-deficiency diseases describe a benefit related to a nutrient-deficiency disease (such as vitamin C and scurvy). However, these statements are only allowed if they also indicate how widespread the disease is in the United States. For the purposes of labeling dietary supplements, section 5 of the DSHEA provides an exemption from labeling requirements for articles in scientific journals, books and other publications used in the sale of dietary supplements. These materials must be reprinted in their entirety, not be false or misleading, not promote a specific brand or manufacturer, present a balanced view of scientific information, and be physically separated from the supplements being sold.
Sellers of health-related products, including dietary supplements, should be aware of the requirements of FDA and FTC law that labeling and advertising claims must be truthful, not misleading and well-founded. These three types of statements do not have prior approval from the FDA, but the manufacturer must demonstrate that the statement is true and not misleading and must send a notification to the FDA with the text of the statement no later than 30 days after marketing the dietary supplement along with the statement. The legal notice must also state that the dietary supplement is not intended to diagnose, treat, cure or prevent any disease, since only a drug can legally make such a claim.
Scientific Evidence for Dietary Supplement Claims
Studies that do not meet basic principles such as placebo controls, double-blinds, sufficient randomization, size and duration, use appropriate endpoints, and show statistically significant results between the treatment group and the control group are more prone to biases and other confounding factors. They are unlikely to yield reliable results and generally do not meet the FTC's competent and reliable standard of scientific evidence to substantiate health-related claims. The first step in evaluating the veracity and accuracy of advertising and marketing materials is to identify all the express and implicit statements that are transmitted to consumers who act reasonably.If a dietary supplement label includes such a claim, it must indicate in a disclaimer that the FDA has not evaluated the claim. The DSHEA did not modify the FTC Act or have any effect on it, and the DSHEA label disclaimer is not required in other forms of advertising or marketing. For example, a supplement that contains at least 200 milligrams (mg) of calcium per serving could claim to be high in calcium. Unlike drugs, supplement manufacturers cannot claim that their products can treat, diagnose, prevent, or cure diseases.
Conclusion
It is important for manufacturers of dietary supplements to understand what claims they can make about their products. While they cannot make claims about treating or curing diseases, they can make claims about providing nutrients that may help prevent certain diseases.It is also important for manufacturers to understand what type of scientific evidence is needed to support their claims. Finally, it is important for manufacturers to include disclaimers on their labels indicating that their products have not been evaluated by the FDA.
