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  5. Formulation Technology, Inc. - 672905 - 07/09/2024
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WARNING LETTER

Formulation Technology, Inc. MARCS-CMS 672905 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Matthew D. McBride
Recipient Title
President/Co-Owner
Formulation Technology, Inc.

571 Armstrong Way
Oakdale, CA 95361
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States

WARNING LETTER

July 9, 2024

WL 672905

Dear Mr. McBride:

This is to advise you that the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 571 Armstrong Way, Oakdale, CA, from October 24 through November 9, 2023.

Based on inspectional findings and review of the product labeling collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov. At the conclusion of the inspection on November 9, 2023, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483).

We acknowledge receipt of your response dated December 5, 2023, and we address your responses below.

Unapproved New Drug

FDA reviewed product labeling for (b)(4) product following the inspection of your facility between October 24 and November 9, 2023. The claims on the product labeling establish that the product (b)(4) is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.

Examples of some of the claims that provide evidence that the product is intended for use as a drug include:

  • Product name, (b)(4): The product name implies the product is intended to cure, mitigate, treat, or prevent migraines.

On the finished product label for (b)(4):

  • “(b)(4).”
  • “(b)(4).”

The (b)(4) product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, 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.

Adulterated Dietary Supplements

The inspection of your facility on October 24, 2023, through November 9, 2023, identified significant violations of the FDA’s regulations for Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations Part 111 (21 CFR Part 111). These violations cause the dietary supplements manufactured at your facility to be adulterated within the meaning of 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 requirements for dietary supplements. Specifically, these violations cause the (b)(4) product manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act. Also, in addition to being an unapproved new drug, your (b)(4) product is likewise an adulterated dietary supplement for the same reason.

Your significant violations of dietary supplement cGMP requirements are as follows:

1. You failed to establish component specifications for each component that you used in the manufacture of your (b)(4) dietary supplement, as required under 21 CFR 111.70(b).

Specifically, during the inspection, the investigator noted that you failed to establish 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(b)(3). Notably, your (b)(4) and (b)(4) component specification sheets are lacking heavy metal specifications. These two components, which are used to manufacture the (b)(4) product, are botanicals and are at risk for heavy metal contamination.

2. You failed to establish product specifications for strength of the finished batch for each dietary supplement that you manufacture to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).

Specifically, as observed during the inspection, you failed to establish product specification for strength for each finished batch of your (b)(4) product. We received and reviewed your December 5, 2023 written response and determined it inadequate. Your finished product specification sheet for your (b)(4) product is lacking adequate strength specifications. The method listed on the finished product specification sheet for determining the strength of (b)(4), and (b)(4) in the finished product is by “input.” While measuring input may be a useful process control, it is not an appropriate test method for determining the strength specification of these ingredients in the finished batch of dietary supplement.

Misbranded Dietary Supplements

We reviewed product labels collected during the inspection and have determined the (b)(4) and (b)(4) products you manufacture are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Thus, in addition to being an unapproved new drug, your (b)(4) product is also a misbranded dietary supplement. Specifically, we identified the following:

1. The (b)(4) product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the serving size declared on the label is incorrect. The terms "serving" or "serving size" for a dietary supplement are defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example, the serving size declared in the Supplement Facts label for all intended groups is 2 caplets, whereas the recommended use is one caplet twice a day with food for children (b)(4) years. Furthermore, there is no correlation between the serving size for children ages (b)(4) years that appears in the Supplement Facts label and the recommended use that appears on the product labeling.

2. The (b)(4) and (b)(4) products are misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of each product label does not comply with 21 CFR 101.36. For example:

a. (b)(4)

  • The title, “Supplement Facts”, is not set at full width of the nutrition label in accordance with 21 CFR 101.36(e)(1).
  • A light bar is not placed beneath the heading “Amount Per Serving”, which as not in accordance with 21 CFR 101.36(e)(7).
  • The subheading “Servings Per Container” does not appear under the subheading “Serving Size”, which is not in accordance with 21 CFR 101.36(b)(1)(ii).
  • The dietary ingredients that comprise the proprietary blend do not appear to be indented, which is not in accordance with 21 CFR 101.36(c)(2).
  • There is no provision in the regulation for the footnote symbol *** to link to a statement within the Supplement Facts label that describes the constituents of the proprietary blend.

b. (b)(4)

  • A heavy bar is not placed beneath the final (b)(2)-dietary ingredient, which is not in accordance with 21 CFR 101.36(e)(6)(ii).

This letter is not intended to be an all-inclusive list of the violations that may 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 your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also offer the following comment:

1. We note that the (b)(4) finished product specification for Lead is < (b)(4) ppm and for Arsenic is < (b)(4) ppm. Your batch record for (b)(4) batch (b)(4) reports lead results of (b)(4) ppm. Under 21 CFR 111.70(e), you must establish specifications for limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement. We request that your response address the scientific basis for setting a specification for lead at < (b)(4) ppm as a level that will not adulterate the dietary supplement.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct these 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your firm’s response to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Formulation Technology, Inc.
1201 Harbor Bay Parkway
Alameda, CA 94502

Refer to Unique Identification Number CMS #672905 when replying.

If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.

If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.

Sincerely,
/S/

Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5

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