Editor's Note
FDA sent this warning letter to 360 Bullet Inc. for website claims that allegedly establish that the products are drugs because they were marketed to cure, mitigate, treat, or prevent disease. FDA also considers some of the company's products to be adulterated dietary supplements because they were allegedly prepared, packed, or held under conditions that do not meet CGMP regulation. FDA acknowledges the company’s email response concerning observations noted on the Form FDA 483, Inspection Observations, but says it is unable to determine the adequacy of the company's corrective actions due to a lack of documentation in the response.
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Bulletproof 360, Inc., located at 1012 First Avenue, Suite 400, Seattle, Washington, on August 12-15, 20, 22, 28 and September 3 and 6, 2019. The inspection revealed serious violations of FDA's regulation for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products 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 they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Additionally, FDA reviewed your website, www.bulletproof.com. Based on our review, we have determined that certain of your products are in violation of sections 505(a) and 502(f)(1) of the Act [21 U.S.C. §§ 355(a) and 352(f)(1)].

We received your email correspondence dated October 11, 2019, concerning the observations noted on the Form FDA 483, Inspection Observations, that was issued at the close of the inspection. We address your response below, in relation to the adulterated dietary supplement violations.

Unapproved New Drugs and Misbranded Drugs

FDA reviewed your website at the Internet address, www.bulletproof.com, in March 2020, and has determined that you take orders there for the products Curcumin Max and Mitosweet. The claims on your website establish that the products are drugs under section 201 (g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.

Examples of some of the claims on your website that provide evidence that your products are intended for use as drugs include:

1. The article titled "13 ANTI-AGING SUPPLEMENTS TO TURN YOU INTO BENJAMIN BUTTON" states: "Curcumin [an ingredient in your Curcumin Max product] ... blocks the production of inflammatory cells and proteins. Here's why that's a big deal: Chronic inflammation puts you at risk of serious conditions like cancer, heart disease, diabetes, and Alzheimer's ....  How to take it : Two softgels daily of Bulletproof Curcumin Max, with food."

2. The article titled "D-RIBOSE: THE SWEETENER THAT BOOSTS ENERGY AND WON'T SPIKE YOUR BLOOD SUGAR" says D-ribose is "the main ingredient in Bulletproofs natural sweetener, Mitosweet" and directs consumers to "Buy Bulletproof Mitosweet now." The article states, "D-ribose increases ATP levels in heart cells, giving this muscle the energy it needs to do its job. One study found that D-ribose helped heart failure patients breathe easier, a sign that more blood was getting pumped to the heart. Ribose also lowers LDL ("bad") cholesterol and oxidized fat - these can build up in your arteries as plaque, blocking the flow of blood to the heart."

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301 (d) and 505(a) of the Act [21 U.S.C. §§ 331 (d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

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). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Curcumin Max and Mitosweet products are intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for its 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 these misbranded drugs violates section 301 (a) of the Act [21 U.S.C. § 331 (a)].

Adulterated Dietary Supplements

Your Chocolate Collagen Protein and Vanilla Collagen Protein products are adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
We understand that your firm establishes the component and product specifications for your dietary supplement products. We also understand that you are responsible for verifying that your finished packaged dietary supplements meet product specifications, and that you instruct a co-manufacturer to release your finished packaged dietary supplements into distribution.

During the inspection, FDA investigators observed the following significant violations of the CGMP regulations for dietary supplements:

1. You failed to establish component specifications, as required by 21 CFR 111.70(b), for each component that you use in the manufacture of a dietary supplement. Specifically, you must establish an identity specification for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). The document you purport to use as your specifications for your bovine hydrolyzed collagen protein (a component used in your Chocolate Collagen Protein and Vanilla Collagen Protein products) lists characteristics for identity that are not sufficient to determine the identity of this component, as these characteristics also describe hydrolyzed collagen protein derived from other animal sources.

We have reviewed your response dated October 11, 2019, which states that you have established an identity specification for each component that you use in the manufacture of your dietary supplements. However, we cannot evaluate the adequacy of your corrective actions, because you did not provide component specifications along with your response.

2. You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you have not established product specifications for the composition of your Chocolate Collagen Protein and Vanilla Collagen Protein products.

Once you have established the specifications, as required by 21 CFR 111.70, you must take specific actions to determine whether the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75. You must also ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of all activities relating to such specifications, in accordance with 21 CFR 111.95.

We have reviewed your October 11, 2019, response, but we are unable to evaluate the adequacy of your corrective actions, as you did not provide product specifications along with your response.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31 (a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

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