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- Subchapter D. Drugs For Human Use
- Part 310. New Drugs
- Subpart E. Requirements For Specific New Drugs Or Devices
21 C.F.R. §310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use
| Cite as | 21 C.F.R. §310.530 |
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FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
- United States
- LexBlog United States
- 12 Octubre 2009
...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.......