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Legal packaging for foods and supplements

2022-07-12 naturalproductsinsider

Tag: packaging Claim legal compliance

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Per federal labeling laws, the nutrition label for a dietary supplement is called a "supplement facts" panel. Federal laws require that the names and quantities of dietary ingredients including the product, the "serving size" and the "servings per container" be present in this panel.

Federal laws further mandate that the supplement fact panel must be enclosed in a box by using hairlines unless a special exception applies. The title, "Supplement Facts," must be larger than all other print in the panel and, unless impractical, must be set to the full width of the panel. The title and all headings must be bolded to distinguish them from other information.

Slack fill laws and regulations dictate how much non-functioning space can exist inside of product packaging. They are most prevalent for consumables like food, and their designed purpose is to prevent product packaging that is misleading to consumers. The rationale is that sellers should not be able to make products seem bigger—or more plentiful—than they are. As a general rule, it is illegal to market a non-drug product as a treatment or cure for a specific disease or to alleviate the symptoms of a disease. Dietary supplements may not bear disease claims, explicit or implied, unless the claim has undergone premarket review by FDA and has been authorized or approved under the rules for health claims or drugs, as appropriate.

A "health claim" is an explicit or implied characterization of a relationship between a substance and a disease or a health-related condition. This type of claim requires significant scientific agreement and must be authorized by FDA. The claim can be a written statement, a "third party" reference, a symbol, or a vignette.  21 CFR 101.14(a)(1) and (c).

"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 (e.g., "calcium builds strong bones"). In addition, they may characterize how a nutrient or dietary ingredient acts to maintain such structure or function (e.g., "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.

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