21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use
| Cite as | 21 CFR 310.530 |
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2 practice notes
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Food for human consumption: Food labeling Dietary supplements; effect on structure or function of body; types of statements, definition,
...drug labeling unless the product has been shown to be safe and effective for the implied or suggested use. (See also Sec. 310.530 (21 CFR 310.530) (use of the word ``hormone'' in labeling is an implied drug claim).) Moreover, courts have upheld FDA's authority to regulate implied drug claim......
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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
...drug labeling unless the product has been shown to be safe and effective for the implied or suggested use. (See also Sec. 310.530 (21 CFR 310.530) (use of the word “hormone” in labeling is an implied drug claim).) Moreover, courts have upheld FDA’s authority to regulate implied drug claims.......
1 firm's commentaries
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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
...drug labeling unless the product has been shown to be safe and effective for the implied or suggested use. (See also Sec. 310.530 (21 CFR 310.530) (use of the word “hormone” in labeling is an implied drug claim).) Moreover, courts have upheld FDA’s authority to regulate implied drug claims.......