Recalls and Warnings

Bulletproof Warned for Manufacturing Violations

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(Date Posted: 3/31/2020)

On March 20, 2020, the FDA issued a warning letter to Bulletproof 360, Inc., which found the company's products, including Curcumin Max, Mitosweet, Chocolate Collagen Protein, and Vanilla Collagen Protein, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

[Note: In 2019, ConsumerLab tested Bulletproof 360's Chocolate Collagen Protein and published its findings in its Collagen Supplements Review.]

These violations include failure to establish identity specifications for each component used in the manufacture of a supplement and failure to establish product specifications for the identity, purity, strength, and composition of each batch of supplements, as required by federal regulations.

In addition, certain statements made about the products on the company's website were found to be drug claims. For example, the use of curcumin, an ingredient in the company's Curcumin Max, was promoted to "block the production of inflammatory cells and proteins," which the site stated can help prevent "serious conditions like cancer, heart disease, diabetes, and Alzheimer's."

See ConsumerLab.com's Reviews of Turmeric & Curcumin Supplements and Spices and Collagen Supplements (including collagen protein powders) for tests of related products.

The company is required to notify the FDA in writing of the specific steps taken to correct the violations within fifteen working days of receipt of the warning letter.

In 2018, Bulletproof 360 recalled their collagen protein supplement because it contained undeclared milk.

See related recalls and warnings:

Seller of Liposomal Curcumin, Vitamin C & Melatonin Warned for Manufacturing Violations

Seller of Curcumin, Garcinia, Glucosamine and More Warned for Manufacturing Violations

Bulletproof Collagen Protein Recalled

Maker of Collagen Supplement Warned for Manufacturing Violations

For more information, use the link below.

Warning Letter: Bulletproof 360 Inc



For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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