The Zero Ingredient Claim for Dietary Supplements

by Christine Hronec

In today’s competitive market for health and nutrition products, companies are always seeking the best ways to differentiate their brand. Marketers use everything from fancy packaging, to holographic labels, to specialty colored resins, to set their product lines apart. However, today’s consumers are making more educated purchasing decisions, and are utilizing the Supplement Facts label panel as one of the primary purchasing factors. Naturally companies shift their focus to catch the eye of the consumer through the Supplement Facts Label. Unfortunately what most brands do not know is that taking a product to market without having the label reviewed by an FDA attorney can unintentionally introduce a misbranded product.

Dietary supplements are different from foods, which require a Nutrition Facts panel, as conventional foods are comprised of macro and micronutrients that need to be claimed against the FDA’s daily recommended values for each nutrient. However supplements are not required for daily health and are “supplemental” to the body’s daily needs according to the FDA. For protein supplements, marketers want to highlight the fact that their product many have zero carbs or zero fats but listing it as such on the supplement facts panel is actually “misbranding”.

The rule clearly states that companies are only to list the nutrients, vitamins, and minerals that are present in the dietary supplement product which can be listed as having more than a zero amount. According to 21 CFR 101.36(b)(2), specifically at the top of page two which provides: ”ANY (b)(2)-DIETARY INGREDIENTS (which are total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carb, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron) THAT ARE NOT PRESENT, OR THAT ARE PRESENT IN AMOUNTS THAT CAN BE DECLARED AS ZERO IN 101.9(c), SHALL NOT BE DECLARED.”

The draft Supplement Facts Panel examples provided in that regulation by the FDA, specifically on pages 7,8, 9 and 10, shows that no nutrients, vitamins, or minerals are listed in zero amounts, and in some cases, no nutrients are listed at all and only the ingredients that are contained in the product. Attached is a recent letter which affirms this labeling issue. (See warning letter to God’s Garden Pharmacy, specifically the second bullet point under Misbranding)

Many supplement products have an ingredient declaration of one ingredient. This is a regulation that many marketers strategically do not comply with, but this is unquestionably contrary what the law says. For any questions or concerns regarding your product label, FDA and/or FTC compliance, Muscle Gauge Nutrition’s Private Label services include a complimentary label review for all clients that opt to use MGN’s design services.

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