Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994. The act amended the FD&C Act by reducing previous restrictive regulations that sometimes caused the FDA to classify some dietary supplements as a drug and therefore remove them from the shelf. The new act reflected Congress’s’ view that changes were necessary given the relationship between diet and health and the potential to mitigate diseases that places a strain on the public purse. Also, they recognized that problems and complaints associated with the use of dietary supplements were minimal.
What is a Dietary Supplement?
Dietary supplements as the name suggests, are supplements, meaning that they should not replace the diet but help to increase the dietary intake of one or more nutrients. Use of the supplements must be by ingestion. Therefore, a nasal spray that contains vitamins would not be deemed as a dietary supplement. Dietary supplements may include:
- Amino acids
- Concentrates, metabolites and extracts
- A dietary substance to increase the dietary intake
- A combination of the above
How Dietary Supplements are Approved?
Congress established less stringent rules for regulating dietary supplements than conventional foods. Since dietary ingredients are not classified as food additives, dietary supplements are not subject to the Delaney Clause. The Delaney Clause is a provision in the Food Additives Amendment of 1958 which says that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive. Manufacturers only needed to show that the dietary supplement is “reasonably expected to be safe” when used as intended, instead of “absolutely” safe, under the Delaney Clause. Therefore, no pre-market approval is required for dietary supplements if the dietary supplement was approved before 1994 when DSHEA was passed. However, if the dietary supplement is new i.e. approved after 1994, then the manufacturer is required to submit information to the FDA to demonstrate that the product “can reasonably be expected to be safe”, within 75 days of introduction to commerce. Failure of the FDA to object to the sale of the supplement does not mean FDA approval. The statute requires that the FDA must bear the burden of proof that the product is unsafe.
Labeling of Dietary Supplements
General labeling requirements for dietary supplements are similar to conventional foods. However dietary supplements differ in the following ways:
- The nutritional information is called “supplement facts”
- “Serving size” represents the manufacturer’s “recommended amount” to be taken instead of the usual amount that is consumed
- Each nutritional component is listed with their quantity or “proprietary blend” followed by a list of ingredients in decreasing order
- The term “dietary supplement” is listed in its statement of identity or the name of the dietary ingredient e.g. probiotic supplement”
- Nutrients with no daily value established are presented with the footnote “Daily value not established”
- A reasonable amount of excess dietary ingredients is allowed in the formula, however no more than 20% excess is allowed for calories, sugars, total fat, saturated fat, cholesterol, or sodium
Type of Claims to Make on Dietary Supplements
Claims made for dietary supplements are the same as for conventional foods. That is, nutrient-content claim, health claim, structure/function claim, general well-being claim, and classical nutrient-deficiency claim. Structure/function claims are the most common that you will see on dietary supplements. This type of claim must be accompanied by the 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.” Manufacturers are required to submit information to the FDA within 30 days of marketing a dietary supplement, that the claims used are truthful and not misleading.
Are Your Dietary Supplements Safe?
Remember that dietary supplements are supplements and not a replacement for good health practices such as eating adequately and exercising. However, if you do take supplements to overcome deficiencies, look for the United States Pharmacopeia (USP) trade mark. This mark demonstrates and authenticates the quality of the dietary supplement. The trademark is owned and copyrighted by a nonprofit organization called United States Pharmacopeial Convention which sets standards for drugs, food ingredients and dietary supplements. The standards are enforced by the FDA.
In addition to checking for the mark of quality, also look out for false labeling. Some red-flagged words and phrases that usually catch my attention and raise my skepticism include:
- “New breakthrough discovery”
- “No side effects”
- “Backed by scientific research”
Remember, “if it sounds too good to be true…….”
Reference: Sanchez, M. C. (2015). Food law and regulation for non-lawyers – A US perspective. New York, NY: Springer International.