Friday, July 6, 2018

Categories of DSHEA Claims - July 2018 Newsletter

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Categories of DSHEA Claims

While you are thinking about August's Proposition 65 Deadline, here is a summary of the FDA's web page on the types of claims that can be made for foods and supplements. [1]

Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:

          Health Claims
          Nutrient Content Claims
          Structure/Function Claims

As I've said many times... beneficial formulas are "easy."  Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.

Health Claims

"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition.  They require prior FDA approval.

Ther are 3 ways a health claim may be used on a label or in labeling (the sales information that makes up the "extended label" according to FDA) for a conventional food or dietary supplement:

1) the 1990 Nutrition Labeling and Education Act (NLEA) allows FDA to regulate  health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative (the Neuro Food Defect Claim is an example);

2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research -- FDA has 120 days after application to allow or not; can be used during application period;

3) as described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (Pearson v Shalala Claims), the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling. There are about two dozen approved Qualified Claims. The Vitamin Consultancy offers a Health Claims Webinar describing each.

Nutrient Content Claims

"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value... Healthy is an implied nutrient content claim that characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." ..."

Structure/Function Claims and Related Dietary Supplement Claims

"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States. These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help!