FDA WARNING_LETTER - Eden’s Answers Inc. and Sprigs Life Inc. - August 17, 2017
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On August 1-17, 2017, the FDA inspected Eden's Answers Inc. and Sprigs Life Inc. and reviewed their website, www.sprigslife.com, identifying serious violations. Products like Pedia Para-Free, Lil' Ones Breathe Easy, Respiratory Aid, Raw Elderberry and Honey, and Women's Hormonal Help – Life Stage 2 are deemed unapproved new drugs under 21 U.S.C. 321(g)(1)(B) due to disease treatment claims. These products are not generally recognized as safe and effective, violating 21 U.S.C. 331(d) and 355(a).
Additionally, Respiratory Aid and Women's Hormonal Help – Life Stage 2 are misbranded under 21 U.S.C. 352(f)(1) because they lack adequate directions for layperson use, being intended for conditions requiring professional supervision.
Even if not unapproved drugs, Pedia Para-Free, Lil' Ones Breathe Easy, Respiratory Aid, Raw Elderberry and Honey, and Lil' Ones Calm and Focus are misbranded dietary supplements under 21 U.S.C. 343. Violations include incorrect serving sizes (21 CFR 101.9(b), 101.12(b)), non-compliant nutrition information presentation (
ID · 4c1e5a7b-26cc-49f5-94fd-dc70b3043f39
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