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WARNING LETTER

Anti L’Age MARCS-CMS 698661 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Arash A. Mohrdar
Recipient Title
Owner
Anti L’Age

6086 Brockton Ave Ste 6
Riverside, CA 92506
United States

Isabelle@Mohrdar.com
Issuing Office:
Human Foods Program

United States

WARNING LETTER

CMS #698661

Dear Dr. Arash Mohrdar:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 6086 Brockton Ave, Riverside, CA 92506 from September 17, 2024, through October 4, 2024. Based on inspectional findings and our review of the product label 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 October 4, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). As of the date of this letter, we have not received a response to the FDA 483.

Adulterated Dietary Supplements

The inspection of your facility from September 17, 2024, through October 7, 2024, identified serious violations of the FDA’s regulations 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 the dietary supplement products 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.

Your significant violations of the CGMP requirements are as follows:

1. Your firm did not establish product specifications for 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 dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, your representative acknowledged that you did not establish finished product specifications for identity, purity, strength, and composition, or limits on contamination for your ESR Amino, Transfer Factor C, and Heart Amino
supplements. In addition to establishing the required specifications, you must take all required steps to determine if the established specifications have been met (see, e.g., 21 CFR 111.75).

2. For components that are used in the manufacture of dietary supplements, your firm did not establish specifications for identity, purity, strength, and composition, or limits on those types of contamination that may adulterate or 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). Specifically, your representative acknowledged that you have not established component specifications for components used in the manufacture of your ESR Amino, Transfer Factor C, and Heart Amino supplements. In addition to establishing the required specifications, you must take all required steps to determine if the established specifications have been met (see 21 CFR 111.75).

3. Your firm did not establish specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d). Specifically, your representative acknowledged that you have not established any specifications for the packaging and labels used to manufacture Heart Amino, ESR Amino, and Transfer Factor C. In addition to establishing the required specifications, you must determine whether such specifications have been met (see 21 CFR 111.75).

4. Your firm did not prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205. Specifically, your representative acknowledged that you do not have master manufacturing records for any of the dietary supplements you manufacture.

5. Your firm did not prepare a batch production record every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, your representative acknowledged that your firm doesn’t have any batch records for any of the dietary supplements you manufacture.

6. Your firm did not establish and follow written procedures for the responsibilities of quality control operations, as required by 21 CFR 111.103. Specifically, your representative acknowledged that you have no written procedures for the responsibilities of the quality control operations.

7. Your firm did not collect and hold reserve samples of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, your representative acknowledged you do not keep any reserve samples of any of your packaged and labeled dietary supplements.

8. Your firm did not quarantine components before you used them in the manufacture of a dietary supplement, as required by 21 CFR 111.155(c), and your firm did not establish written procedures relating to the quarantine of components, as required by 21 CFR 111.153. Specifically, your representative acknowledged that you do not have a separate and distinctly marked quarantine area or a system in place within the warehouse for components, packaging, or labels; and that you do not have any quarantine procedures for items received from suppliers.

9. Your firm did not establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.16. Specifically, your representative acknowledged that you do not have procedures for cleaning and sanitation of your physical plant and grounds.

10. Your firm did not establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, your representative acknowledged that your firm has no such written procedures for any of the dietary supplements that you hold and distribute.

11. Your firm did not establish and follow written procedures for product complaints, as required by 21 CFR 111.553. Specifically, your representative acknowledged that you have no written procedures for product complaints.

Misbranded Dietary Supplements
In addition, we reviewed your product labels collected during the inspection and have determined the ESR Amino, Transfer Factor C, and Heart Amino products you manufacture and distribute 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. Specifically, we identified the following:

  • Your ESR Amino (powder and capsules), Transfer Factor C (powder and capsules), and Heart Amino powder products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. For example, “Nutritional Supplement” is not an acceptable statement of identity for a dietary supplement.
  • Your ESR Amino (powder and capsules), Transfer Factor C (powder and capsules), and Heart Amino powder products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.
  • Your ESR Amino (powder and capsules), Transfer Factor C (powder and capsules), and Heart Amino powder products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that the product labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
  • Your ESR Amino (powder and capsules) products are 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 labels is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Specifically, the directions suggest taking 1 to 3 teaspoons twice a day (for powders) and 3 capsules 2 times a day (for capsules), but the Supplement Facts label declares 1 tsp as the serving size for both.
  • Your ESR Amino (powder and capsules), Transfer Factor C (powder and capsules), and Heart Amino powder products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.9 and 21 CFR 101.36. For example:
    􀁸 The statement “Daily Value Not Established” is not linked to a symbol linking it to the heading “%DV heading”, which is not in accordance with 21 CFR 101.36(b)(2)(iii)(F).
    􀁸 The number of Servings Per Container is not listed, which is not in accordance with 21 CFR 101.9(d)(3)(i).
    􀁸 The serving size is not expressed using a term that is appropriate for the form of the supplement, which is not in accordance with 21 CFR 101.36(b)(1)(i). Milliliters (mL) is not appropriate for powders and capsules.
    􀁸 The labels are missing the quantities of each ingredient listed, which is not in accordance with 21 CFR 101.36(b)(2)(i)(A) and 21 CFR 101.36(b)(3)(ii).
  • Your ESR Amino (powder and capsules), Transfer C (powder and Capsules), and Heart Amino Powder products are misbranded within the meaning of section 403(r)(6) of the Act [21 U.S.C. 343(r)(6)] because the labels make structure/function claims but fail to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).
  • Your ESR Amino (powder and capsules), Transfer C (powder and capsules), and Heart Amino Powder products are misbranded within the meaning of section 403)(s)(2)(A)(ii)(l) of the Act [21 U.S.C. 343(s)(2)(A)(ii)(l)] because the labels are missing the quantities of each ingredient listed, as required by 21 CFR 101.36(b)(2)(i)(A).

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.

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 have the following comments:

  • During the inspection your representative acknowledged that there are no batch, lot, or control numbers assigned to each of your finished dietary supplements, and that the Lot Number 75001 that appears on your dietary supplement labels does not represent anything. To ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, you must assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement [see 21 CFR 111.415(f)].

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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.

Your written reply should be directed to Lauren Crivellone, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS # 698661 on any submissions and within the subject line of any emails to us.

If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Laura Akowuah, JD, MPH
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Food and Drug Administration

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