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|Articles|July 20, 2021

Supplement Labels 101: Know the dietary supplement requirements and regulations before you go to market

A label is a product’s calling card, a company’s effort to put its best foot forward. So why is it that dietary supplement labels are so often laden with problems?

A label is a product’s calling card, a company’s effort to put its best foot forward. So why is it that dietary supplement labels are so often laden with problems? It partly has to do with new companies not knowing what FDA’s rules are regarding nutritional supplement labels.

In our industry, however, one of the most important components of any successful labeling and package design effort is FDA compliance. Without it, your supplement cannot be sold in the U.S. To avoid unfortunate reformatting and reprinting costs, a brand owner should make FDA-compliant packaging a priority.

FDA Regulations — Where the Rubber Hits the Road

The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic (FD&C) Act in many important ways, notably by requiring that most foods, including dietary supplements, bear nutrition labeling.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) updated the Act, in part, by defining dietary supplement, adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.

On September 23, 1997, FDA implemented DSHEA by publishing several key regulations (62 FR 49826) on the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements.

On June 5, 1998, FDA amended the regulations (63 FR 30615) concerning the nutrition labeling of extracts used in dietary supplements.

FDA has provided and published industry guidance on dietary supplement labeling, which should be carefully reviewed by any brand owner preparing to create and sell dietary supplements to consumers.1

What Is a Dietary Supplement?

Now, although the industry’s understanding of what is considered a dietary supplement has gone through several iterations over the years, let’s review what a dietary supplement is supposed to be:

  • A product that is taken orally
  • A product that is “intended to supplement the diet”
  • A product that contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance used to supplement the diet by increasing total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any ingredient intended above

In addition, the product must be labeled as a dietary supplement and must not be represented for use as a conventional food or as the sole item of a meal or the diet. (Note: this part of the definition does not mean we are only talking about weight-loss or dietary products.)

Furthermore, a dietary ingredient used in a dietary supplement must either have a new dietary ingredient (NDI) number, have Generally Recognized as Safe (GRAS) status, or be a documented old dietary ingredient (ODI; having been in the marketplace prior to October 1994).

The key regulatory impact of DSHEA is that a product that meets the definition of a dietary supplement does not need FDA preapproval of safety and effectiveness before being marketed.

What About Beauty?

Cosmetic products are a whole different class of products, for which structure/function and health claims are not allowed, although manufacturers often forget this.

For example, a dietary supplement may be able to use the following structure/function claim: “Helps reduce fine lines and wrinkles.” A cosmetic product cannot make this claim, however, since cosmetics cannot alter the body’s structure or function. However, a cosmetic could make the claim: “Helps reduce the appearance of fine lines and wrinkles,” In this instance, the use of the word appearance changes the claim from structure/function to a cosmetic claim—since cosmetics are supposed to impact a person’s appearance. It’s a subtle difference, but it makes a big difference from a regulatory perspective.

Under the FD&C Act, a cosmetic is considered misbranded if:

  1. Its labeling is false or misleading in any particular
  2. Its label does not include all required information
  3. The required information is not adequately prominent and conspicuous
  4. Its container is made, formed, or filled as to be misleading
  5. It is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act
  6. Its packaging or labeling violates an applicable regulation issued according to section 3 or 4 of the Poison Prevention Packaging Act of 1970 (FD&C Act, Section 602)

Claims for Dietary Supplements

What about claims for dietary supplements? There are a few general categories of claims for dietary supplements.2 These include:

  1. Health claims
  2. Structure/function claims (the primary category of claims)
  3. Qualified health claims
  4. Nutrient content claims

Following is a brief discussion of each of these.

Health Claims

Disease or health claims show a link between a food or substance and a disease or health-related condition. Examples of approved health claims include:

  • Adequate dietary calcium may help to reduce the risk of developing osteoporosis later in life.
  • Folic acid taken during pregnancy may help reduce the risk of neural tube defects.

The number of health claims is extremely limited. If you choose to use one of them (and if your product qualifies for the claim), you must adhere to the exact wording without any deviation.

Structure/Function Claims

Structure/function claims refer to the supplement’s effect on the body’s structure or function, including its overall effect on a person’s well-being.

Examples of structure/function claims include “Calcium builds strong bones” and “Antioxidants maintain cell integrity.”

The use of a structure/function claim requires the use of one of the following disclaimers in boldface type in a type size no smaller than one-sixteenth (1/16th) inch inside of an outline box using high-contrast colors between the background and the copy:

  • Singular: “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;” or
  • Plural: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

You may not modify the wording of these disclaimers.

You must place the disclaimer immediately adjacent to the claim with no intervening material, or elsewhere on the same panel or page that bears the statement. In the latter case, the disclaimer must be placed in a box and linked to the statement by a symbol (e.g., an asterisk) placed at the end of each statement that refers to an identical symbol placed adjacent to the disclaimer. A structure/function claim must have call-outs to the FDA disclaimer wherever there is a claim on the product. Typically, use an asterisk or cross symbol to link the statements together.

I recommend that all brand owners, especially new ones, have all their product claims reviewed by a nutraceutical industry expert, as well as an FDA and FTC attorney.

Nutrient Content Claims

Nutrient content claims describe the level of a nutrient in a food or dietary supplement. The nutrient content claim “high source of” can be used if a dietary supplement contains at least 20% of the daily value for a given nutrient. For example, since the daily value for vitamin C is 90 mg, a product containing at least 18 mg of vitamin C can be said be “a high source of vitamin C.” If a product contains at least 10% of the daily value, it can be said to be a “good source of” that nutrient.

Food Allergens

While stating what’s in a dietary supplement is paramount, there are also regulations governing what’s not in a product, as well—namely, food allergens, for which the FDA has provided guidance, too.3

What About Problem Claims?

  1. Outrageous claims. Most of us have seen supplements that promise to help make us thinner, more intelligent, stronger, faster, or improve our sex life without making any other lifestyle changes. Just as with other products, if it sounds too good to be true, it probably is.
  2. “All-natural.” Unlike the term organic, all-natural is not an official term regulated by the federal government and does not offer any guarantee as to a product’s safety.
  3. “Pharmaceutical strength.” This is another one to watch out for, as there is no such thing as pharmaceutical strength for over-the-counter dietary supplements.

Not only is proper dietary supplement labeling the law and required, accurate and fully transparent labels show consideration for consumers since it allows them to compare apples to apples, so to speak, when standing in the aisle at their favorite health-food store.

Vincent Tricarico is the executive vice president of Twinlab Consolidation Corporation and NutraScience Labs (Farmingdale, NY). With over 20 years of direct-to-consumer and business-to-business experience, Tricarico is a respected executive in the dietary supplement industry and is well known for his ability to consistently build and grow successful teams that produce results. Over the years, he has been featured in numerous publications, including Entrepreneur, Medium.com, Natural Products Insider, Nutritional Outlook, and WholeFoods Magazine.

References

  1. FDA. Dietary Supplement Labeling Guide. Published April 2005.
  2. FDA. Small Entity Compliance Guide on Structure/Function Claims. Published January 2002.
  3. FDA. Guidance for Industry: Questions and Answers Regarding Food Allergens. Published November 2006.

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