What happened
Original notice title
Edenâs Answers Inc. and Sprigs Life Inc. 12/14/17
From the archived source record
Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at www.sprigslife.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drugs FDA reviewed your website at the Internet address www.sprigslife.com in October 2017 and has determined that you take orders there for the products Pedia Para-Free, Lil’ Ones Breathe Easy, Respiratory Aid, Raw Elderberry and Honey, and Women’s Hormonal Help – Life Stage 2. A drug is misbranded under section 502(f)(1) of the Act [(21 U.S.C. § 352(f)(1)]) if the drug fails to bear adequate directions for its intended use(s). Accordingly, Respiratory Aid and Women’s Hormonal Help – Life Stage 2 fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Misbranded Dietary Supplements Further, even if your Pedia Para-Free, Lil’ Ones Breathe Easy, Respiratory Aid, and Raw Elderberry and Honey products were not unapproved new drugs, these products would still be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. Our review of your product labels revealed that your products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as follows: 1. Your Respiratory Aid, Pedia Para-Free, Raw Elderberry and Honey, Lil’ Ones Calm and Focus, and Lil’ Ones Breathe Easy products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size declared on the labels are incorrect.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 4c50553c7026
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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