April 20, 2021

FDA Claims Explained

By Health Plus

According to the Council for Responsible Nutrition, more than 170 million Americans take dietary supplements annually. The dietary supplement category includes vitamins, minerals, botanicals, sports nutrition supplements, weight management products and specialty supplements. While dietary supplements are not intended to replace or be a substitute for a well-balanced diet, they are used to boost or complement a diet. When used properly, dietary supplements support a healthy lifestyle and help promote good health.

Unfortunately, some people are hesitant to use dietary supplements because of the belief that they are ‘unregulated’. Nothing could be further from the truth. In fact, the Food and Drug Administration (FDA), the Federal Trade Commission (FTC) as well as additional government agencies in each of the 50 states work in conjunction to oversee and regulate the dietary supplement industry to ensure products are safe before authorizing their approval.

Consumers need to be aware that virtually all aspects of manufacturing, product labeling, marketing and product ingredients are covered by an extensive number of regulations issued and enforced by the FDA. In addition to the FDA, the Federal Trade Commission oversees and regulates dietary supplement advertising. The law mandates that all ads must be truthful, not misleading and backed by scientific evidence when health claims are used.

 To help inform consumers, the FDA has established three types of health claims that are permitted to be displayed on a dietary supplement product. Here is a description of what each claim means:

Nutrient content claim

A Nutrient content claim must list the amount or characterize the level of a nutrient in a product. For example, a nutrient claim can state that it is a ‘good source of Vitamin D’ or is ‘high in antioxidants’ or ‘free of’ a certain ingredient based on the serving size. The nutrient content claim can also suggest that the product may be useful in maintaining healthy dietary practices such as “healthy, contains 3 grams of fat”. To avoid misleading the consumer, manufacturers can only make nutrient content claims that are specifically defined in FDA’s regulations. 

structure function claims

This claim describes how a product may affect an organ or a certain system within the body. However, the claim may not reference any specific disease. For example, a claim can say that it ‘works as an antioxidant’ which describes an action of an ingredient but it cannot say that it will prevent pain. Or, a claim can say that it ‘helps maintain cardiovascular health’ which speaks to the effect the supplement has on the cardiovascular system but it cannot say that it will treat or cure heart disease.

 While Structure/function claims do not require FDA approval, the manufacturer must provide the FDA with the actual text they plan to use in the claim within 30 days of putting the product on the market. Product labels containing this type of claim must also include a disclaimer that reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”. 

FDA-approved health claims or qualified health claims

Similar to a Structure/function claim, this statement describes a relationship between a dietary supplement ingredient and the reduced risk in developing a health-related condition. For example, a psyllium husk product can claim that it ‘may reduce the risk of heart disease’ but cannot say it will prevent it. Moreover, the FDA must review the scientific evidence being cited in the health benefit before they will allow the product to be sold to consumers. Statements or studies done by federal scientific institutions such as the National Institutes of Health and the National Academy of Sciences can be referenced as qualified health claims.

Additional label information required by fda

general information

  • Name of product including the word “supplement” or a statement that the product is a dietary supplement
  • Net quantity of contents
  • Name and address of manufacturer, packer, or distributor
  • Directions for use 

supplement facts panel

  • Serving size, list of dietary ingredients, amount per serving size by weight, percent of Daily Value (%DV), if established
  • If an ingredient is sourced from a botanical, the scientific name of the plant or its common name as well the plant part used must be listed
  • If the dietary ingredient is a proprietary blend, the total weight of the blend and the components of the blend must be listed in order of predominance by weight

other ingredients

Non-dietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders must be listed by weight in descending order of predominance and by common name or proprietary blend.

While most of the information found on a product label is regulated and overseen by the FDA, some manufacturers seek third party certification as well. Going through a certification process often requires a brand to go above and beyond what is federally mandated in order to gain a seal of approval. The California Certified Organic Farmers (CCOF) seal is just one example of an independent group that manufacturers, such as Health Plus, turn to for validation based on the organization’s high standards for farming organic ingredients.

So next time you are considering taking a dietary supplement, take a close look at the label. It provides all the information you need to know about the product as well as the measures that are taken by the manufacturer to ensure that it is safe and effective.

sources

https://www.crnusa.org/resources/dietary-supplements-safe-beneficial-and-regulated
https://fda.gov
https://ods.od.nih.gov/factsheets/DietarySupplements-Consumer/

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