What happened
Original notice title
Rock Farm, LLC dba WholeFood Farmacy MARCS-CMS 552814, September 17, 2018
From the archived source record
Based on our review, we have concluded that certain products are in violation of sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 355(a) and 352(f)(1)]. In addition, we have determined that your Joule and Joule “Micro-Electric Current” products are adulterated within the meaning of section 402(c) of the Act [U.S.C. 342(c)] because they bear a non-permitted color additive. Further, based on our review, we have concluded that your Joule, Joule “Micro-Electric Current,” Stardust2Hydr8, and Hydrating Stardust products are in violation of section 403 of the Act [21 U.S.C. 343] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Unapproved New Drugs and Misbranded Drugs FDA reviewed your Farmacy Pro Power Superfood Probiotic Energy Blend, Joule, Joule “Micro- Electric Current,” Stardust2Hydr8, and Hydrating Stardust “A pH Infused Oral IV” product labels following the inspection of your facility. Also beneficial in avoiding or clearing internal bacterial infections.” “For thousands of years people avoided or cleared internal bacterial infections by drinking an oral infusion made from water, salt, leavening made from salt, and Stevia . . . Stardust 2 Hydr8 is handcrafted from Baking Soda, Stardust Pure Salt, and Stevia Leaf.” Hydrating Stardust “A pH Infused Oral IV” Product label: “For thousands of years people avoided or cleared internal bacterial infections by drinking an oral infusion made from water, salt, leavening made from salt, and Stevia . . . 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, these 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)].
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
- 4a7ccabb3ff2
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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