WARNING LETTER
Vidaslim Co.
MARCS-CMS 705118 —
July 17, 2025
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Ashley A. Alonso
Recipient Title
Owner
Vidaslim Co.
5018 San Pedro Ave.
San Antonio
,
TX
78212-1452
United States
ashley@vidaslim.com
Issuing Office:
Human Foods Program
United States
July 17, 2025
WARNING LETTER
CMS #705118
Dear Ms. Alonso:
The U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 5018 San Pedro Ave. San Antonio, Texas, from December 9 through December 20, 2024. Based on inspectional findings and review of the product labels 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 December 20, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated January 16 and March 3, 2025, and we address your responses below.
Adulterated Dietary Supplements
The inspection of your facility from December 9 through December 20, 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 supplements products distributed by you 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. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.
Specifically, during the inspection, your management stated that you
(b)(4)
. Additionally, your management could not provide any documentation that you are performing any quality control operations for receiving, packaging, labeling, holding, and distributing your dietary supplements, including approving and releasing product for distribution.
Your responses dated 1/16/25 and 3/3/25 include
(b)(4)
procedures under the heading of “
(b)(4)
.” None of the procedures you included in the response are signed or dated as “effective,” and your responses indicated that your corrective actions relating to this issue were still in progress. Additionally, although you have draft written procedures, you have not demonstrated that you are following these written procedures.
2. Your firm failed to make written procedures for holding and distributing operations, and you failed to keep records of product distribution, as required by 21 CFR 111.475(b). Specifically, during the inspection, your management stated that you
(b)(4)
.
Your responses dated 1/16/25 and 3/3/25 state you
(b)(4)
. We are unable to evaluate your corrective actions based on the information provided.
3. Your firm failed to collect and hold reserve samples of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, during the inspection, your management stated that you
(b)(4)
.
Your responses dated 1/16/25 and 3/3/25 state that you
(b)(4)
. We are unable to evaluate your corrective action based on the information provided.
4. You failed to establish and follow written procedures for the requirements for product you received for packaging or labeling as a dietary supplement, as required by 21 CFR 111.153.
Specifically, you received
(b)(4)
.
Your responses dated 1/16/25 and 3/3/25 state that you
(b)(4)
. We are unable to evaluate your corrective action based on the information provided.
5. You failed to make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint, as required by 21 CFR 111.570(b).
Specifically, during the inspection, your management stated that you
(b)(4)
.
Your responses dated 1/16/25 and 3/3/25 state that you
(b)(4)
. We are unable to evaluate your corrective action based on the information provided.
6. You failed to establish written procedures for returned dietary supplements, as required by 21 CFR 111.503.
Specifically, during the inspection, your management stated that you
(b)(4)
.
Your responses dated 1/16/25 and 3/3/25 state that you
(b)(4)
. We are unable to evaluate your corrective action based on the information provided.
7. You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403.
Specifically, you
(b)(4)
.
Your responses dated 1/16/25 and 3/3/25 state that you
(b)(4)
, but that the procedure has not been finalized or implemented. We are unable to evaluate your corrective action based on the information provided.
We will review all of your proposed procedures when they are fully implemented.
Misbranded Dietary Supplements
In addition, we reviewed your product labels collected during the inspection and have determined the Vidaslim Total Control Fat Burning Capsules, Vidaslim Mujer Hormonal Balance, Vidaslim Calma Relax Gummies, Vidaslim Flaca ACV Gummies, Vidaslim Sueños Sleep Gummies, Vidaslim 15 Day Detox, Vidaslim Gut Check Probiotic Super Greens, Vidaslim Hydroboost Pro, Vidaslim Pretty Potion Acai Berry Flavor, Vidaslim Ganas, and the tejocote root products Vidaslim 30 Day Supply and Vidaslim 90 Day Supply products you 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:
8. Your Vidaslim Gut Check Probiotic Super Greens, Vidaslim Pretty Potion Acai Berry Flavor, and Vidaslim Ganas products are misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
9. Your Vidaslim Gut Check Probiotic Super Greens product is misbranded within the meaning of section 403(i)(2) of the FD&C Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4.
Specifically, your Vidaslim Gut Check Probiotic Super Greens product label claims
(b)(4)
but fails to declare the common or usual name of this ingredient in the Supplement Facts label or in an “
(b)(4)
” list.
10. Your Vidaslim Flaca ACV Gummies and Vidaslim Sueños Sleep Gummies products are misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §§343(s)(2)(A) and 343(q)(5)(F)] in that the labels fail to list the name of each dietary ingredient of the supplements that are described in section 201(ff) and the quantity of each such dietary ingredient, as required by 21 CFR 101.36.
For example, your Vidaslim Flaca ACV Gummies label suggests that
(b)(4)
. However, these dietary ingredients and their quantitative amounts by weight per serving are not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3). If these ingredients are not dietary ingredients, the ingredients are also not declared in an “
(b)(4)
” list in accordance with 21 CFR 101.4(g).
Your Vidaslim Sueños Sleep Gummies label suggests that
(b)(4)
. However, these dietary ingredients and their quantitative amount by weight per serving is not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3). If these ingredients are not dietary ingredients, the ingredients are also not declared in an “
(b)(4)
” list in accordance with 21 CFR 101.4(g).
In addition, your Vidaslim Mujer Hormonal Balance, Vidaslim Calma Relax Gummies, Vidaslim Gut Check Probiotic Super Greens, Vidaslim Pretty Potion Acai Berry Flavor, Vidaslim Ganas, Vidaslim 30 Day Supply and Vidaslim 90 Day Supply 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 products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. For example:
- Your Vidaslim 30 Day Supply and Vidaslim 90 Day Supply products fail to declare the (b)(3)- dietary ingredients below the (b)(2)-dietary ingredients, as required by 21 CFR 101.36(b)(3)(i);
- Your Vidaslim 30 Day Supply and Vidaslim 90 Day Supply products fail to declare the quantitative amount by weight for each ingredient in the Supplement Facts label, as required by 21 CFR 101.36(b)(2)(i)(A) and 101.36(b)(3)(ii);
- Your Vidaslim Gut Check Probiotic Super Greens product fails to express the quantitative amount by weight per serving of the Proprietary Blend “
(b)(4)
” using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100 mg must be expressed as 1.1 g), as required by 21 CFR 101.36(b)(3)(ii)(A);
- Your Vidaslim Gut Check Probiotic Super Greens product fails to list the dietary ingredients contained in the proprietary blend formula for “Super Green Blend,” “Fiber Blend,” and “Digestion Enzyme Blend” as required by 21 CFR 101.36(c)(1);
- Your Vidaslim Pretty Potion Acai Berry Flavor products’ proprietary blends fail to declare the quantitative amount by weight totaled from the weight of all the dietary ingredients contained in the proprietary blend, as required by 21 CFR 101.36(c)(3);
11. The heading “Amount Per Serving” for your Vidaslim Gut Check Probiotic Super Greens and Vidaslim Hydroboost Pro products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product by using the term “dietary supplement” as a part of the product’s statement of identity, as required by 21 CFR 101.3(g).
12. Your Vidaslim Total Control Fat Burning Capsules, Vidaslim 15 Day Detox, and Vidaslim Gut Check Probiotic Super Greens products are misbranded within the meaning of Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the labeling makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)-(d). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30-days of marketing the product bearing the claim; and the claim includes the mandatory disclaimer.
13. Your Vidaslim Gut Check Probiotic Super Greens product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel (PDP) in accordance with 21 CFR 101.7 and 15 U.S.C.§ 1453(a)(2) of the Fair Packaging and Labeling Act.
14. Your Vidaslim Ganas product is misbranded within the meaning of Section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the number of servings is inconsistent with the net content of the package. The principal display panel (PDP) states
(b)(4)
.
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.
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 Sara J. Dent Acosta 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 # 705118 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/
Maria S. Knirk, JD, MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
09/30/2025
Regulated Product(s)
Dietary Supplements