Rule CG-ABS-050

Absolute promises: what rule CG-ABS-050 checks

Rule CG-ABS-050 is one of the checker's absolute promises rules. It cites 21 CFR 201.63. The reason, source and safer wording are below.

CG-ABS-050 · Blocks approval · Citation checked against stored text
Saying a product is safe during pregnancy or breastfeeding, with no limit, is an unqualified safety claim. Safety in pregnancy is rarely studied, and FDA requires over-the-counter drugs absorbed into the body to tell pregnant or breast-feeding users to ask a health professional first. Without substantiation it is also a deceptive claim.
Source: FTC Act section 5 (claims need a reasonable basis); 21 CFR 201.63 (pregnancy/breast-feeding warning for OTC drugs); FTC Health Products Compliance Guidance
Safer wording: Remove "safe for pregnancy" or "safe while nursing". If you have evidence, state what it covers and add "Ask your health care professional before use if you are pregnant or breastfeeding."
21 CFR 201.63 · Needs counsel review

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