What happened
Original notice title
Maine Natural Health, Inc. 12/19/17
From the archived source record
During the inspection, our investigator found a number of violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products Vanilla Recovery Whey Protein and Peppermint SO3+D3 Fish Oil to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements in 21 CFR Part 111. Based on our review of the labeling and the website, we have concluded that your SO3 + D3 Fish Oil, Fuel Whey Protein, Strong Strength + Muscle, Pure Whey Protein, and Push Pre-Workout 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 21 CFR 101. Your significant violations are as follows: Unapproved New Drugs As explained above, the claims on your website establish that your SO3 + D3 Fish Oil, SO3 Fish Oil, Recovery Whey Protein, Strong Strength + Muscle, and Pure Whey Protein products are drugs under section 201(g)(1)(B) of the Act because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: SO3 + D3 Fish Oil “Vitamin D [an ingredient in the product] may improve heart health…. heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.” “Benefits of fish oil [an ingredient in the product] include: reduced inflammation” “[T]he omega-3 fatty acids in fish oil [an ingredient in the product]….have shown beneficial results for a variety of health problems….like high blood pressure and arthritis.
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
- 390a5d9d90fd
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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