What happened
Original notice title
Chill6 MARCS-CMS 611422, July 20, 2021
From the archived source record
Additionally, even if your Chill6 were not an unapproved new drug and misbranded drug, it would be an adulterated food and misbranded food, as described below. 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, Chill6 (all flavors) fails to bear adequate directions for its intended use and, therefore, the product is 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)]. Adulteration – Unsafe Food Additive Even if your Chill6 product, all flavors, was not an unapproved new drug and misbranded drug, it would be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains phenibut HCl, an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(C)(i)]. Because phenibut HCl does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Chill6 product (all flavors) is adulterated under section 402(a)(2)(C)(i) of the Act because it contains an unsafe food additive. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)]. Misbranded Foods Even if your Chill6 product (all flavors) were not an unapproved new drug and a misbranded drug, it would be a misbranded food under section 403(a)(1) of the Act.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 9e4baa6534d5
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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