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AE Copies A CONTINUING BIBLIOGRAPHY With INDEXESACCESSION NUMBER RANGES Accession numbers cited in this Supplement fall within the N7 I I935 1 N 7 12 1850Series) I&A(AOQ i!3fri$s). A 122057A7 125
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01
Understand the definition of permissible and impermissible structurefunction claims.
02
Determine if your product qualifies for a permissible structurefunction claim based on the criteria set by the FDA.
03
If your product does not meet the criteria for a permissible claim, avoid making impermissible claims to avoid regulatory issues.
04
Clearly label and market your product with accurate structurefunction claims to ensure compliance.

Who needs permissible vs impermissible structurefunction?

01
Manufacturers and marketers of dietary supplements and other health products need to understand the difference between permissible and impermissible structurefunction claims.
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Regulatory affairs professionals in the health and wellness industry must be knowledgeable about permissible vs impermissible structurefunction claims to ensure compliance.
03
Consumers who rely on structurefunction claims to make informed decisions about their health and wellness products should be aware of what constitutes a permissible claim.
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Permissible structure/function claims are those that describe the role of a nutrient or dietary ingredient in affecting normal structure or function of the body, while impermissible claims imply that a product treats or prevents disease.
Manufacturers of dietary supplements and functional foods must file permissible structure/function claims to comply with FDA regulations, while those making impermissible claims may face enforcement actions.
To fill out a permissible structure/function claim, ensure it accurately reflects the ingredient's effect on health, is substantiated by scientific evidence, and meets FDA guidelines. Impermissible claims should not be included.
The purpose is to inform consumers about the health benefits of dietary supplements while preventing misleading or unsubstantiated claims that suggest treatment or prevention of diseases.
Information that must be reported includes the specific claims being made, the scientific evidence supporting those claims, and disclaimers that the product is not intended to diagnose, treat, cure, or prevent any disease.
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