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WARNING LETTER

Ultra Perform, Inc. MARCS-CMS 534404 —


Delivery Method:
VIA UPS
Product:
Dietary Supplements

Recipient:
Recipient Name
Adam Tageldin
Recipient Title
Owner
Ultra Perform, Inc.

860 S. Washington Street
Salt Lake City, UT 84101
United States

Issuing Office:
Office of Human and Animal Foods - Division IV West

United States


November 22, 2017

WARNING LETTER

Ref. No: HAF4W(DEN)-18-01-WL

Dear Mr. Tageldin:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Ultra Perform, Inc., located at 860 South Washington Street, Salt Lake City, Utah, on June 14 and 19, 2017. Based on the inspection, a review of the product labels collected during the inspection, and a review of your website, www.ultraperform.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA's website at www.fda.gov.

Dietary Supplement CGMP Violations

Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, 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 Act [21 U.S.C. § 342(g)(1)], in that the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. The following CGMP violations were observed during the inspection:

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.

Once you have established your quality control written procedures, you must implement them into your labeling and holding operations, as required by 21 CFR 111.65 and you must implement a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in a master manufacturing record, as required by 21 CFR 111.55. The quality control personnel must ensure that your labeling and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Furthermore, you must have documentation of the quality control personnel review and approval of release or rejection for any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 111.140(b)(2).

Specifically, during the inspection you stated that you have no written quality control procedures for dietary supplements that are made by your contract manufacturers. You further indicated that your contract manufacturers do the manufacturing, packaging, and in some cases, labeling of your finished dietary supplements including but not limited to: WOW! Men's formula (with DHEA), WOW! Women's formula (with DHEA), Xcellerator, and KICK-BUTT ENERGY. You told our investigator that you do not have quality agreement(s) with your contract manufacturers.

As a dietary supplement distributor that contracts with a manufacturer to manufacture a dietary supplement that you distribute under your own label, you have an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products are in compliance with dietary supplement CGMP requirements.

Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has "a responsible share in the furtherance
of the transaction which the statute outlaws"); United States v. Park, 421 U.S. 658,672 (1975) (holding that criminal liability under the FD&C Act does not turn on awareness of wrongdoing, and that "agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act" can be held accountable for violations of the FD&C Act). The Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331 (a)). Thus, a firm that enters a contract with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.

2. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). Specifically, during the inspection you told the investigator that you sold all the retain samples that were available on site. For each lot of packaged and labeled supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container-closure system in which the packaged and labeled dietary supplements were distributed in accordance with 21 CFR 111.83(b).

3. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you informed our investigator that you did not have written procedures for the holding and distributing operations for your dietary supplement products.

4. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, including the review and investigation of any product complaints, as required by 21 CFR 111.553. Specifically, you have not established written procedures for handling product complaints. In addition to making and keeping a record of the procedures for handling product complaints, you must make and keep a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2).

5. You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, our investigator found your firm does not have written procedures regarding the handling of returned dietary supplements.

6. You failed to establish and follow written procedures to fulfill the requirements related to labeling operations, as required by 21 CFR 111.403. Specifically, our investigator found your firm does not have written procedures regarding the labeling operations for your dietary supplements. You stated that at times, your firm will conduct labeling for short runs.

New Dietary Ingredient

Your products, Xcellerator Performance and Kick-Butt Energy, which you market as dietary supplements, purport to contain "Citrus Aurantium Extract (Standardized to 60% synephrine). " Section 201 (ff)(1) of the Act (21 U.S.C. § 321(ff)(1)] defines the term "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Citrus Aurantium Extract (Standardized to 60% synephrine) qualifies as a dietary ingredient.

Under section 413 of the Act, a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f)(1)(B) of the Act (21 U.S.C. § 342(f)(1)(B)] unless it contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or there is a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

To the best of FDA's knowledge, there is no information demonstrating that "Citrus Aurantium Extract (Standardized to 60% synephrine)," was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. Nor is FDA aware of any information demonstrating that this dietary ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. In the absence of such information "Citrus Aurantium Extract (Standardized to 60% synephrine)," is subject to the notification requirements for a new dietary ingredient in section 413(a)(2) of the Act (21 U.S.C. § 350b(a)(2)) and 21 CFR 190.6. Because you have not submitted the required notification, your Xcellerator Performance and Kick-Butt Energy products are adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. §§ 342(f)(1)(B) and 350b(a)).

Misbranded Dietary Supplements

1. The WOW! Men (60 capsules/110 capsules), WOW! Men Daily Sexual Vitamin (20 capsules/30 capsules), WOW! Women's formula, Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 and 343(q)(5)(F). For example,

a. The WOW! Women 20 capsules and WOW! Men 110 and 60 capsules product labels fail to include the quantitative amount of the proprietary blends as required by 21 CFR 101.36(c)(3).

b. Although the WOW! Men (60 capsules/110 capsules), WOW! Men Daily Sexual Vitamin (20 capsules/30 capsules), WOW! Women's formula, Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules product labels may list the (b)(2)-dietary ingredients that make up part of the proprietary blend, such (b)(2)-dietary ingredients may only be listed if they are at least 2% of the RDI for the specific dietary ingredient and they are also listed in the (b)(2)-dietary ingredient section of the Supplement Facts label, in accordance with 21 CFR 101.36(c)(1).

c. The source ingredient for the dietary ingredients Vitamin B12 and [Vitamin] B6 is not listed for the WOW! Men (60 capsules/110 capsules), WOW! Women's formula, Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules in accordance with 21 CFR 101.36(d) and 101.4.

d. For the WOW! Men (60 capsules/110 capsules), WOW! Men Daily Sexual Vitamin (20 capsules/30 capsules), WOW! Women's formula, Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules product labels, the symbol (i.e., asterisk) that is placed at the bottom of the nutrition label and followed by the statement "Daily Value not established" does not link to any other asterisk within the Supplement Facts label. A symbol ( e.g., asterisk), which refers to the same symbol placed at the bottom of the nutrition label that is followed by the statement "Daily Value not established," must be placed under the heading "% Daily Value," if present, or immediately following the quantitative amount by weight for the proprietary blend in accordance with 21 CFR 101.36(c)(3).

e. The WOW! Men 110 capsules, WOW! Men Daily Sexual Vitamin (20 capsules/30 capsules), Xcellerator (60 capsules/90 capsules), and WOW! Women's formula (with DHEA) product labels fail to place a heavy bar under the heading Serving Size/Servings per
container and the last other dietary ingredient ((b)(3)-dietary ingredient) per 21 CFR 101.36 (e)(6).

f. The Kick-Butt Energy product label fails to bear a heavy bar below "Servings per container". The Xcellerator product labels (60 capsules/90 capsules) do not appear to distinctly distinguish between heavy and light bars in the Supplement Facts label in accordance with 21 CFR 101.36(e)(6).

g. The WOW! Men 110 capsules, WOW! Women's formula (20 capsules), Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules product labels list "B6" not in accordance with 21 CFR 101.36(b)(2) and 101.9(c)(8)(iv).

h. The dietary ingredients in your Wow! Men's formula and WOW! Women's formula, Xcellerator, and KICK-BUTT ENERGY proprietary blends are not declared in descending order of predominance by weight, as required by 21 CFR 101.36(c)(2).

2. The WOW! Women's formula is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a current domestic address or domestic phone number through which the responsible person as described in section 761(b) of the Act [21 U.S.C. C 379AA-1] may receive a report of a serious adverse event with such dietary supplement. "You informed our investigator that the address is no longer correct and the phone number on this label has been disconnected. Therefore, this information is not current to meet the requirement.

3. The WOW! Men Daily Sexual Vitamin 30 capsules is misbranded within the meaning of section 403(e)(l) of the Act [ 21 U.S.C. § 343(e)(l)] in that the label does not contain an accurate statement of the place of business of the manufacturer, packer, or distributor, in accordance with 21 CFR 101.5(d). You informed our investigator that the incorrect address for the Distributor - Source Tantra was on the label. The label lists a P.O. Box in Kahului, Hawaii, however, this firm has since moved to California: 261 West Hilton Drive Boulder Creek, CA 95006. Also, the WOW! Men 20 capsules contains an incorrect address listed at 2223S 1300E, Suite E6211, SLC, UT 84106.

4. The Xcellerator 60 capsules and Kick-Butt Energy 60 capsules products are misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act in that each product label lists ingredients that are not consistent with the applicable product formulation. For example, the Xcellerator product label lists Acai Berry but this ingredient is not listed in the product formulation sheet collected by our investigator (entitled "(b)(4) Product Specification"). Furthermore, this Xcellerator product composition sheet lists (b)(4) extract but this ingredient is not listed on the label.

5. The WOW! Men (60 capsules/110 capsules), WOW! Men Daily Sexual Vitamin 20 capsules, WOW! Men Daily Sexual Vitamin 30 capsules, WOW! Women's formula, Xcellerator 60 capsules, and Kick-Butt Energy 60 capsules products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the each of the labels fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the products are derived, as required by 21 CFR 101.4(h)(l).

6. The WOW! Men (60 capsules/110) capsules products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the label fails to include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).

7. The WOW! Men (60 capsules/110 capsules), WOW! Men Daily Sexual Vitamin (20 capsules/30 capsules), WOW! Women's formula, Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules products are misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act in that each product label lists names such as B6, magnesium (as other dietary ingredient), DHEA, yerba mate, and EGCG which are not the common or usual names of an ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(a) and (h).

We note that you have not provided a response to the FDA 483 issued to you on June 19, 2017. Without a response, we are unable to assess any potential corrective actions.

The above violations are not intended to be an all-inclusive statement of violations that exist in your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of the Act and its implementing regulations. You should take prompt action to correct violations cited in this letter and establish procedures to ensure such violations do not recur. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

We offer you the following labeling comments:

• The WOW! Men (60 capsules) and WOW! Mean Daily Sexual Vitamin (20 capsules/30 capsules) products list the term "inert ingredients' which is not in accordance with 21 CFR 101.4(g).

• The PRECAUTIONS, FDA disclaimer, and Customers Report statements as positioned on the WOW! Men (60 capsules/I IO capsules), WOW! Men Daily Sexual Vitamin (20 capsules/30 capsules), WOW! Women's formula, Xcellerator (60 capsules/90 capsules), and Kick-Butt Energy 60 capsules product labels are intervening material per 21 CFR 101.2(e).

Within fifteen (15) business days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of supporting 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.

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 noncompliance 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-3 l(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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related to costs from the responsible party for the domestic
facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.

Address your reply to the U.S. Food and Drug Administration; Attn: Caroline H. Le, Pharm.D., Compliance Officer, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Dr. Le at (303) 236-3045 if you have any questions about this matter.


Sincerely,
/S/
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods - Division IV West

 
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