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WARNING LETTER

Xcel Sports Nutrition, LLC MARCS-CMS 507547 —

Recipient:
Xcel Sports Nutrition, LLC

United States

Issuing Office:
Dallas District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food Operations West Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204

 

June 8, 2017
 
2017-DAL-WL-24
 
WARNING LETTER
 
UPS Overnight
 
Donald L. Clement, Owner
Becky Bram Clement, Owner
Xcel Sports Nutrition, LLC
7408 82nd Street
Lubbock, Texas 79424
 
Mr. and Mrs. Clement:
 
From May 23 to May 27, 2016, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 7408 82nd Street, Lubbock, Texas. During the inspection, our investigator found a number of violations of the Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21, Code of Federal Regulations Part 111 (21 CFR Part 111). These violations cause your Xcel Sports Nutrition, XLSN (Xcel Sports Nutrition), and Ironclad Sports Nutrition brand dietary supplements 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 insanitary conditions that do not meet cGMP regulations for dietary supplements. 
 
In addition, we have reviewed the labeling for your Xcel Sports Nutrition, XLSN (Xcel Sports Nutrition), and Ironclad Sports Nutrition brand products, including product labels and your website at www.xcelsportsnutrition.com. Based on our review, we have concluded that your products are misbranded under Section 403 of the Act [21 U.S.C. § 343], and regulations implementing the dietary supplement labeling requirements of the Act, which are found in 21 CFR 101. You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
 
This letter also concerns your Xcelerator XTC Pre-Workout Blackberry Limeade, Kranked Preworkout Busted Black Cherry Limeade, and Dominatrix Pineapple Mango products, which are labeled and/or offered for sale as dietary supplements.
 
The Supplement Facts panel on your Xcelerator XTC Pre-Workout Blackberry Limeade product declares Acacia rigidula as a dietary ingredient. This ingredient is also called, among other names, Vachellia rigidula, chaparro prieto, and blackbrush, and will be referred to in the rest of this letter as A. rigidula.
 
As an herb or other botanical, A. rigidula is a dietary ingredient under Section 201(ff)(1)(C) of the Act [21 U.S.C. § 321(ff)(1)(C)].  Further, as a dietary ingredient that was not marketed in the United States before October 15, 1994, A. rigidula is a “new dietary ingredient” under Section 413(d) of the Act [21 U.S.C. § 350b(d)].
 
Under Section 413 of the Act [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under Section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
 
1.    The dietary supplement 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,
 
2.    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 A. rigidula was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered.  In the absence of such information, A. rigidula is subject to the notification requirement in Section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6.  Because the required notification has not been submitted, your product is adulterated under Sections 402(f)(1)(B) and 413(a) of the Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)].
 
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated.  In the absence of a history of use or other evidence of safety establishing that A. rigidula, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, Xcelerator XTC Pre-Workout Blackberry Limeade product is adulterated under Sections 402(f)(1)(B) and 413(a) of the Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)] because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.  Introduction of such products into interstate commerce is prohibited under Sections 301(a) and (v) of the Act [21 U.S.C. §§ 331(a) and (v)]. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that A. rigidula will reasonably be expected to be safe when used as a dietary ingredient.
 
In addition, the Supplement Facts panel on your Dominatrix Pineapple Mango product declares the substance Picamilon as a dietary ingredient. This ingredient is also called, among other names, pikatropin, pikamilon, nicotinyl-gamma-aminobutyric acid, and nicotinoyl-GABA (hereinafter referred to as picamilon).
 
Also, your Kranked Preworkout Busted Black Cherry Limeade product declares R-beta-methylphenethylamine as a dietary ingredient.  This ingredient is also called, among other names, Beta-methylphenethylamine, βMePEA, or BMPEA (hereinafter referred to as BMPEA).
 
Under Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; 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 the preceding substances. Picamilon and BMPEA are not vitamins, minerals, herbs or other botanicals, or amino acids. In addition, according to our research, picamilon and BMPEA are not dietary substances for use by man to supplement the diet by increasing the total dietary intake. Finally, picamilon and BMPEA are not concentrates, metabolites, constituents, extracts, or combination of vitamins; minerals; herbs or other botanicals; amino acids; or dietary substances for use by man to supplement the diet by increasing the total dietary intake. Regarding picamilon, it is a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid.  As such, it is absorbed into the body, crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity. Because picamilon and BMPEA do not fit in any of the dietary ingredient categories under section 201(ff)(1) of the Act, they are not dietary ingredients as defined in the Act.  Declaring picamilon and BMPEA in your products’ labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.
 
We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your Xcelerator XTC Pre-Workout Blackberry Limeade, Kranked Preworkout Busted Black Cherry Limeade, Dominatrix Pineapple Mango products or other dietary supplement products marketed by your firm, including any that contain A. rigidula, picamilon, or BMPEA.  We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.  It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
Failure to immediately cease distribution of your Xcelerator XTC Pre-Workout Blackberry Limeade, Kranked Preworkout Busted Black Cherry Limeade, and Dominatrix Pineapple Mango products and any other products you market that contain A. rigidula, picamilon, or BMPEA could result in enforcement action by FDA without further notice.  Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334].
 
Additionally, picamilon and BMPEA are not approved as food additives or prior sanctioned for use in dietary supplements.  Further, FDA's review of these substances does not identify a basis to conclude the substances are GRAS for use in food.  If you contend that these substances are GRAS for use in dietary supplements, please provide your basis for concluding that picamilon and BMPEA are GRAS for use in dietary supplements, including supporting data or other documentation.
 
Dietary Supplement cGMP Violations
 
The May 23 to May 27, 2016, inspection of your facility revealed the following significant violations of the cGMP requirements for dietary supplements. These violations cause your Xcel Sports Nutrition, XLSN (Xcel Sports Nutrition), and your Ironclad Sports Nutrition products to be adulterated under Section 402(g)(1) of the Act in that they have been prepared, packed, or held under conditions which do not meet the cGMP regulations for dietary supplements. 
 
We understand that your firm operates as a warehouse and distribution center for your dietary supplement products.  We also understand that you develop and approve all product formulations and obtain finished packaged dietary supplements from co-manufacturers that you then label and release into distribution.  Furthermore, your firm establishes labels for your firm’s dietary supplement products, and you have final approval over all aspects of each label for your firm’s dietary supplement products.  During the inspection, you told our investigator that you currently work with co-manufacturers to develop the supplement facts panel on the label (that you ultimately approve).
 
The following cGMP violations were observed during the inspection:
 
1.    You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of dietary supplement to ensure the quality of the supplement, as required by 21 CFR 111.70(e). Specifically, your firm has not established product specifications for your dietary supplement products, including Crackhead Sour Cherry Pina Colada, Junky Juice Preworkout Maui Madness, and Incinerate-X Ice Blue Lemonade Colada. As a co-manufacturer, you are formulating and providing final approval of product formulations. However, in order to do so, you need to know what you are formulating and approving by establishing specifications for each of the products you manufacture. You have not established specifications for the identity, purity, strength, and composition, or limits on those types of contamination that may adulterate or lead to adulteration for any of the finished batches of the dietary supplements you manufacture. Your quality control personnel must not approve and release for distribution any batch of dietary supplement that does not meet all product specifications established in accordance with 21 CFR 111.70(e), as required by 21 CFR 111.123(b)(2). 
 
We have reviewed your response letter, dated June 16, 2016. You state in your response letter “Xcel Sports Nutrition is working diligently with our manufacturers to establish product specifications for finished products. As soon as these have been established, we will forward them to you.” As of the date of this letter, we have not received an updated response that includes product specifications, and therefore we are unable to determine the adequacy of your proposed corrective actions.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
2.    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, as required by 21 CFR 111.103 and 21 CFR 111.140(b). Specifically, you told our investigator that you have not created any written procedures for quality control operations for your firm. 
           
To the extent that you contract with other firms to manufacture, package, and/or label product on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is 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 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 Act). In particular, 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 contracts out some or all of its operations must establish 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 the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, 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 (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).
 
We have reviewed your response letter, dated June 16, 2016. You state in your response letter “Xcel Sports Nutrition is in the process of establishing a Quality and Control Policy.” You further state you will obtain certificates of analyses from your co-manufacturer, and that you will forward this information to us when you receive it. As of the date of this letter, we have not received quality control procedures, and therefore we are unable to evaluate the adequacy of your proposed quality control procedures.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
3.    You failed to establish specifications for dietary supplement labels, as required by 21 CFR 111.70(d). Specifically, you have not established label specifications for your dietary supplements, including Crackhead Sour Cherry Pina Colada, Junky Juice Preworkout Maui Madness, and Incinerate-X Ice Blue Lemonade Colada, that you label and distribute. You explained to our investigator that you have final approval over all of your firm’s brand name supplement labels. Once you have established label specifications, your quality control personnel must ensure labels conform to established specifications, in accordance with 21 CFR 111.120(b). 
 
In your original response letter, dated June 16, 2016, you indicated you were creating label specifications and would provide those upon completion. On August 31, 2016, we received an updated response with a “(b)(4)” from your co-manufacturer, as well as updated labels. However, we are unable to evaluate the adequacy of your proposed corrective actions from this response. For example, we cannot determine if this (b)(4) represents your firm’s label specifications.  We will evaluate the adequacy of your corrective actions at our next inspection.  
 
4.    You failed to prepare a written master manufacturing record (MMR) for labeling operations for each unique formulation of dietary supplement and for each batch size of your dietary supplement products, as required by 21 CFR 111.205 and 21 CFR 111.210. Specifically, you receive unlabeled finished and packaged dietary supplements from your co-manufacturers. You label these dietary supplements at your firm and distribute the finished product. You have not created MMRs for the labeling operations for your dietary supplements, including Crackhead Sour Cherry Pina Colada, Junky Juice Preworkout Maui Madness, and Incinerate-X Ice Blue Lemonade Colada.
 
We have reviewed your response letter, dated June 16, 2016. In your response you state, “Within the next 90 days all labeling in-house will be ceased and all product labeling will take place (b)(4).” We are unable to evaluate the adequacy of your proposed corrective actions because your response does not indicate whether you created MMRs for the duration of time that you have continued labeling operations. While you state that labeling will be performed by (b)(4) in the future, this does not exempt you from adhering to the cGMPs for dietary supplements in the interim.  With respect to your proposed discontinuation of labeling at your firm within the next 90 days, we will evaluate the adequacy of your corrective actions at our next inspection.
 
5.    You failed to establish a batch production record (BPR) for your labeling operations, as required by 21 CFR 111.255 and 21 CFR 111.260. Specifically, you did not create BPRs for dietary supplement products that you labeled and distributed, including your Crackhead Sour Cherry Pina Colada, Junky Juice Preworkout Maui Madness, and Incinerate-X Ice Blue Lemonade Colada dietary supplements. 
 
We have reviewed your response letter, dated June 16, 2016. In your response you state, “Within the next 90 days all labeling in-house will be ceased and all product labeling will take place (b)(4).” We are unable to evaluate the adequacy of your proposed corrective actions because your response does not indicate whether you created BPRs for the duration of time that you have continued labeling operations. While you state that labeling will be performed by (b)(4) in the future, this does not exempt you from adhering to the cGMPs for the labeling operations you perform in the interim for your dietary supplements.  With respect to your proposed discontinuation of labeling at your firm within the next 90 days, we will evaluate the adequacy of your corrective actions at our next inspection.
 
6.    You failed to establish and follow written product complaint handling procedures, as required by 21 CFR 111.553.  Specifically, you did not have written procedures for reviewing and investigating product complaints (see 21 CFR 111.560).  Under 21 CFR 111.553, you must establish and follow written procedures to fulfill the requirements of 21 CFR 111, Subpart O, which relates to product complaints. In addition, you stated that your firm has received product complaints related to satisfaction with the product and that you did not think these complaints required documentation.  We note that you must review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other dietary supplement cGMP requirement (see 21 CFR 111.560(a)(1)). 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).
 
We have reviewed your response letter, dated June 16, 2016, and acknowledge you have created a “Product Complaint Policy & Procedure” document. Your complaint procedure includes documenting all product complaints on a complaint form and notifying your co-manufacturer. This response is inadequate because your procedure does not fulfill the requirements of Subpart O of 21 CFR 111. For example, your procedure does not require a qualified person to review the complaints to determine if the complaint involves a failure of a supplement to meet specifications (21 CFR 111.560(a)(1)), nor does your procedure require quality control personnel to review and approve the findings of any follow-up action (21 CFR 111.560(b)).
 
7.    Your firm failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you stated you have not created any procedures for returned products. Your written procedures for returned dietary supplements must include procedures for complying with all relevant parts of 21 CFR 111, Subpart N.
 
We have reviewed your response letter, dated June 16, 2016, and acknowledge you have created a “Return Product Policy & Procedure” document. We have reviewed this procedure and have determined it is inadequate because it does not appear to fulfill all of the requirements of 21 CFR 111, Subpart N. Specifically, this procedure does not require you to identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision (21 CFR 111.510).  
 
8.    Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you stated during the inspection you had not created written procedures for holding and distributing operations. Written procedures for holding and distributing operations must include procedures for complying with all the relevant parts of 21 CFR 111, Subpart M. 
 
We have reviewed your response letter, dated June 16, 2016, and acknowledge you have created a “Holding and Distributing Policy & Procedure” document. Your procedure includes holding product in a manner that will protect against contamination and deterioration, and includes pest control activities.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
9.    You failed to establish and follow written procedures for labeling operations, as required by 21 CFR 111.403. Specifically, you failed to assign a batch, lot, or control number to each lot of packaged and labeled dietary supplements, as required by 21 CFR 111.415(f)(1). You received two products, Junky Juice and Elite Fruits + Greens, both under the Xcel Sports Nutrition brand name, which did not have a batch, lot, or control number, and to which you failed to assign a batch, lot or control number. You also were also unable to determine the complete manufacturing history and control of your packaged and labeled dietary supplement through distribution, as required by 21 CFR 111.410(d). 
 
We acknowledge your response, dated June 16, 2016, which states you have assigned lot numbers to the product remaining in stock, and that you will no longer be using this same (b)(4) in the future. We also acknowledge you have created a “Policy and Procedures Operations Shipping” document that requires your firm to document the lot number, customer, and number of units distributed from your facility.  We will evaluate the adequacy of your corrective actions at our next inspection.  
 
Misbranded Dietary Supplements
 
In addition to adulterated dietary supplements, your Xcel Sports Nutrition and Ironclad dietary supplements are further misbranded under section 403 of the Act (21 U.S.C. 343) in that the labeling for these products does not comply with the labeling requirements for dietary supplements and other foods, as follows:
 
1.    Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie” and “Dominatrix Pineapple Mango,” product labels are misbranded under Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the place of business in accordance with 21 CFR 101.5.
 
2.    Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Pineapple Ko-Ko Nut,” “Crackhead Xtreme Pre Workout Sour Cherry Pina Colada”, “Junky Juice Pre-Workout Maui-Madness,” “Incinerate-X Ice Blue Lemonade Colada,” and “Xcelerator XTC Pre-Workout Blackberry Limeade” 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 labels fail to include a statement of identity as a “dietary supplement,” as required by 21 CFR 101.3(g).
 
3.    Your “Crackhead Xtreme PreWorkout Sour Cherry Pina Colada”, “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Pineapple Ko-Ko Nut,” “Kranked Pre-Workout Busted Black Cherry Limeade,” and “Incinerate-X Ice Blue Lemonade Colada,” products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7.
 
4.    Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Sour Cherry Pina Colada,” and “Dominatrix Pineapple Mango” dietary supplement 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) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include a complete address or phone number.
 
5.    Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme PreWorkout Pineapple Ko-Ko Nut,” “Crackhead Xtreme PreWorkout Sour Cherry Pina Colada”, “Kranked Pre-Workout Busted Black Cherry Limeade,” “Incinerate-X Ice Blue Lemonade Colada”, “Junky Juice Pre Workout Maui Madness”, “Dominatrix Pineapple Mango” and “Xcelerator XTC Pre-Workout Blackberry Limeade” 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 products does not comply with 21 CFR 101.36. Specifically,
  • Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Pineapple Ko-Ko Nut,” “Crackhead Xtreme PreWorkout Sour Cherry Pina Colada”, “Kranked Pre-Workout Busted Black Cherry Limeade,” “Incinerate-X Ice Blue Lemonade Colada”, “Junky Juice Pre Workout Maui Madness”, “Dominatrix Pineapple Mango” and “Xcelerator XTC Pre-Workout Blackberry Limeade” product labels each bear the statement “Percent Daily Values are based on a 2,000 calorie diet.”  This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of those dietary ingredients is present on the label, so the statement is not permitted.
  • Your “Crackhead Xtreme Pre Workout Ass Kickin’ Apple Pie,” “Crackhead Xtreme Pre Workout Pineapple Ko-Ko Nut,” “Crackhead Xtreme PreWorkout Sour Cherry Pina Colada”, “Kranked Pre-Workout Busted Black Cherry Limeade,” “Incinerate-X Ice Blue Lemonade Colada”, “Junky Juice Pre Workout Maui Madness”, and “Xcelerator XTC Pre-Workout Blackberry Limeade” products incorrectly list several (b)(2)-dietary ingredients (e.g., niacin, Vitamin B6, etc.).  We note that (b)(2)-dietary ingredients may only be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero (e.g., an amount corresponding to less than 2 percent of the RDI for vitamins and minerals), as required by 21 CFR 101.36(b)(2).  Furthermore, an ingredient that is a source of a (b)(2)-dietary ingredient should not be declared in the supplement facts label unless the (b)(2)-dietary ingredient is listed individually.  The source of the (b)(2)-dietary ingredient may be declared either in parentheses, following the listing of the (b)(2)-dietary ingredient or in the ingredient list, or in both locations, as required by 21 CFR 101.36(d).
  • Your Dominatrix product label indicates a number of servings that does not correlate with the serving size and net contents.
  • Your “Kranked Pre-Workout Busted Black Cherry Limeade”, “Junky Juice Pre- Workout Maui Madness”, “Crackhead Xtreme Sour Cherry Pina Colada”, “Crackhead Xtreme Pre-Workout Pineapple Ko-Ko Nut”, and “Crackhead Xtreme Pre-Workout Ass Kickin’ Apple Pie” do not list the phrase “% Daily Value” as a header in the supplement facts label.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or that exist in connection with your products or their labeling.  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 all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as injunction or seizure. 
 
We offer the following additional comments:
 
1.    For each lot of packaged and labeled supplement that you distribute, your firm must collect reserve samples and hold the samples in accordance with 21 CFR 111.83(b). The reserve samples must consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications in accordance with 21 CFR 111.83(b)(4). We note your June 16, 2016, response included monitoring records which demonstrate each product lots’ reserve samples consist of (b)(4) units. Please note that, to comply with 21 CFR 111.83(b)(4), you are required to hold at least twice the quantity needed for tests or examinations.
 
2.    Your firm includes expiration dates on the labels for your dietary supplement products.  Any expiration date and storage conditions you place on a product label should be supported by data that demonstrate the product meets its established specifications at the end of the listed shelf life under the recommended storage conditions [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].  Please note that the term “expiration date” includes shelf life dating as well as ‘‘best if used by’’ dating [See 72 Fed. Reg. 34912, 34856 (Jun. 25, 2007)].
 
3.    We note the phrase “† Daily Value Not Established” on several of your labels. However, the symbol “†” is not linked to any other information on the supplement facts label.
 
4.    Furthermore, for all of your product labels, in the column where the Daily Value is to be entered, we note the symbol “*”. However, only on the Xcelerator XTC Pre-Workout Blackberry Limeade” and “Incinerator-X Ice Blue Lemonade Colada” product labels is there a footnote that corresponds to the symbol “*” and which states “Daily Value not established”.  For the other six product labels, the symbol “*” states “Percent Daily Value Based on a 2,000 Calorie Diet.”  The later error needs to be corrected.
 
You should respond to this letter in writing within fifteen (15) business days from your receipt of this letter.  Your response should outline the specific steps you have taken to correct the violations listed above, including an explanation of each step taken to prevent their recurrence. You should include in your response documentation and any other useful information that would assist us in evaluating your corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining violations. 
 
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-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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
 
 
Sincerely,
/S/                                                           
W. Charles Becoat
Acting District Director
Program Division Director
Office of Human and Animal Food, WD3
                       
                                                           
 
Cc: Mr. Greg Wilburn
            Inspection Unit Manager
            Food and Drug Inspections Branch
            1100 West 49th Street
            Austin, Texas 78756
 
 
 
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