What happened
Original notice title
Baker's Best Health Products, Inc. MARCS-CMS 544600, April 25, 2018
From the archived source record
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, your Eterni-D and Apple Cider Vinegar+ products 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)]. Misbranded Dietary Supplement The dietary supplement products discussed below are misbranded within the meaning of Section 403 [21 U.S.C. § 343] of the Act because they fail to comply with the regulations implementing the food labeling requirements of the Act for dietary supplements, found in 21 CFR Part 101. Additionally, even if your Eterni-D, Colon Formula, and Apple Cider Vinegar+ products did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be misbranded dietary supplements within the meaning of Section 403 of the Act for the reasons described below. 1. Your Eterni-D product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labeling is false and misleading. Your Mind and Memory Formula product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified within the genus Panax. Your Eterni-D product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required 21 CFR 101.4. Your Colon Formula product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels is 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
- 1a86611477b5
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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