Over the past few posts, we've covered some of the history of supplements and products that have been sold to consumers in the United States, as well as some that are still sold. When you pick up a bottle or jar from your pharmacy shelf, there can be a lot crammed on the label. What do you do with all of that information? As an example, let's use a generic store-brand bottle of Vitamin E supplements. The label on the front of the bottle includes the name of the product, the dosage and form of the product, and the quantity in the package. In this case:
In large lettering, this package also declares “supports heart health*” and that it is a “dietary supplement.” The side of the bottle states: “Vitamin E is an antioxidant. It works to protect cell membranes in the nerves, muscles, and cardiovascular system.*”
What's that asterisk all about? Well, in tiny lettering, you'll find the following disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, or prevent any disease.” So, what does that mean? If you're confused, that's quite understandable.
The FDA allows two specific types of health claims on products: Authorized Health Claims, and Qualified Health Claims. In either case, a manufacturer is limited to claims regarding risk reduction for specific diseases, and cannot assert that the product in question will diagnose, mitigate symptoms of, or cure any disease.
An Authorized Health Claim is a statement that has been approved through the FDA's petitioning process and is backed by “significant scientific agreement (SSA)” among qualified experts that a given claim is supported by the totality of scientific evidence on the matter of a particular ingredient or substance and its relationship to a disease or health condition. The authorization outlines in detail what a product may or may not say in their claim and and how it can and cannot be phrased.
The SSA standard sets an intentionally high bar for Authorized Claims, requiring a significant body of consistent information derived from studies that are designed and conducted consistently with agreed upon scientific principles and procedures. An Authorized Claim indicates that, based on current evidence, the science underpinning the claim is unlikely to change. And, if the science does change, the FDA can and will revoke an Authorized Claim to reflect that change in knowledge. Per the FDA website: “The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship.”
An example of an Authorized Health Claim is the relationship between calcium and/or calcium with vitamin D and a reduced risk of developing osteoporosis. The following comes directly from the authorization and describes how a company can refer to the claim on its packaging:
Nature of the claim. A health claim associating calcium or, when appropriate, calcium and vitamin D with a reduced risk of osteoporosis may be made on the label or labeling of a food described in paragraphs (c)(2)(ii) and (d)(1) of this section, provided that:
(A) The claim makes clear the importance of adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, throughout life, in a healthful diet, are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, is the only recognized risk factor for the development of osteoporosis;
(B) The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake, or when appropriate, an adequate dietary calcium and vitamin D intake, throughout life.
Additionally, the company must prove that the product meets certain standards:
- contains an amount of calcium meeting or exceeding the definition of a “high level” of calcium
- contains calcium in a form that is assimilable, meaning that it can be consumed and utilized by the body
- meets the standards for calcium salt disintegration and dissolution as described in the United States Pharmacopeia
- does not contain more phosphorus than calcium by weight
The authorization also allows for inclusion of certain other well-supported information pertaining to calcium and bone health, such as including recommendations on physical activity, the phrase “build and maintain good bone health,” or citing current statistics from the National Center for Health Statistics, the National Institutes of Health, or the National Osteoporosis Foundation.
A “Qualified Health Claim” is a lesser-supported claim that the FDA has reviewed prior to a product being marketed. It does not meet the SSA threshold but some scientific evidence does exist to suggest a relationship between a product and a supposed health benefit. The labeling and claim cannot be misleading or contain false information, so phrasing of the claim must include qualifying language or a disclaimer to relay the current level of scientific evidence available to support the claim. The FDA website lists as an example: “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.”
Finally, the wording on our example from the beginning of this post:“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, or prevent any disease.” Because the statements about the product have not been vetted by the FDA and classified as either Authorized or Qualified Health Claims, the company that manufactures and sells this product cannot make claims about its health benefits. Those asterisks, along with the disclaimer, are a convenient workaround to keep the manufacturer from technically making a misleading or false claim, without having to go through the pre-market evaluation process. It therefore falls on you, the consumer, to be able to wade through the information on a label, and to know the difference between FDA Authorized Claims, FDA Qualified Claims, and the huge grey area that makes up the rest of the supplement industry.