Have you ever come across someone who says that supplements are not safe by pointing out the structure / function claims on the label written as, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”
Here, what it is.
Dietary Supplement Health and Education Act of 1994 (DSHEA)
The Dietary Supplement Health and Education Act of 1994 defines & standardize dietary supplements. The food and drug administration (FDA) effectively regulates the dietary supplements under this act.
As per the DSHEA act there is a standard procedure (structure / function claims) required in labeling a supplement.
- The label should contain the words “dietary supplements”. The word “dietary” can be replaced with the ingredient. E.g. “creatine supplement”, “glutamine supplement”, “protein supplement” etc…
- Net quantity of the content. E.g. “300 grams”, “5 lbs”, “180 tablets” etc…
- “Supplement facts” section containing the nutrition information, serving size (e.g. “1 scoop”), quantity per serving (e.g. “30 grams”) & percent daily value.
- If the supplement contains proprietary blend. The net weight of the proprietary blend with the list of ingredients in the blend mentioned in descending order according to their weight.
- If the supplement is plant-based (botanical) or a herb. The part of the plant used should be mentioned.
- Name and place of business of the manufacturer, packer or distributor.
- Complete list of ingredients in their common names either in descending order of importance or with the source of the ingredient followed by the name of the ingredient (e.g. CLA (derived from safflower seed oil)).
- Safety information that is considered “material” to the consequences that may result from the use of the supplement.
If the supplement bears a structure or function claim, a claim of general well-being, or a claim of a benefit related to a classical nutrient deficiency disease. The below mentioned disclaimer is needed.
- “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”.
Structure / function claims:
The description of the ingredients role, in making changes to the structure or function of the body can be categorized as structure or function claim.
E.g. It is a known fact that protein builds muscle. Thus, a whey protein supplement can claim “builds muscle”.
General well-being claim:
Statements that describe general well-being by consuming a dietary supplement or ingredient are general well-being claims. The general well-being claim do not mention a disease or disease related condition.
E.g. A fat burner can claim “suppress appetite to aid weight loss” but, can’t claim “aids weight loss to cure obesity”.
Claim of a benefit related to a classical nutrient deficiency disease:
These claims are in very little usage in USA. The statement that describes a benefit related to a nutritional deficiency disease along with the reference of how widespread the disease in united states can be classified as claim of a benefit related to a classical nutrient deficiency disease.
These statements do not require pre-approval from the FDA but, should be truthful, authenticated & shouldn’t mislead. The manufacturer is also required to submit a notification with the text of such claims within 30 days of marketing the supplement.
Any supplement manufacturer obeying the DSHEA act will follow the standard labeling requirements and mention the disclaimer in the product label if the supplement bears the structure, function claims.
FDA is not in the business of evaluating health benefits of all supplements. FDA’s job is to prevent the manufacturers of dietary supplements from making unsubstantiated claims.
So if a supplement has 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” it is just a standard procedure & not a warning from FDA. In fact no one really cares about FDA as they are not perfect in evaluating a product.
Troglitazone is a drug prescribed for diabetes approved by FDA. In UK the drug was taken back from the market in 1997 due to liver failure caused by drugs side effect. Thousands of Americans suffered injuries & died due to this drug. The drug was later withdrawn by the FDA. There are many such cases.