Rock Solid Nutrition, LLC 12/22/16

Transcription

1 Rock Solid Nutrition, LLC 12/22/16 December 22, 2016 WARNING LETTER Kansas City District Office 8050 Marshall Drive - Suite 205 Lenexa, Kansas VIA UNITED PARCEL SERVICE OVERNIGHT MAIL RETURN RECEIPT REQUESTED Mr. Sean H. Loseke, Co-Owner Mr. Heath M. Murray, Co-Owner Rock Solid Nutrition, LLC 2424 S.156th Cir. Omaha, NE Reference CMS Case# Dear Mr. Loseke and Mr. Murray: On July 8, 2016 through July 12, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility located at 2424 S 156th Cir, Omaha, Nebraska. We collected product labels during the inspection for products you hold and distribute, including Whey Isolate (Cinnabun flavor), Pre-Pump (Massive Mango flavor), and Strength Test. Based on the inspection and a review of your product labeling, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and the Code of Federal Regulations (CFR) through links on FDA s home page at (

2 We have reviewed your written response dated July 26, 2016, submitted in response to the FDA Form 483 issued to you at the close of the inspection. We have included some detailed comments regarding your response below. Adulterated Dietary Supplements Your dietary supplement products are adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). During the July 8-12, 2016 inspection, our FDA investigator observed the following serious violations of the CGMP regulations for dietary supplements: 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, as required by 21 CFR Specifically, you have not established written procedures for quality control operations for ensuring the quality of incoming finished dietary supplement products, such as Pre-Pump, Whey Isolate, and Strength Test. Your written procedures for quality control operations must ensure that reserve samples are collected and held, all established specifications are met, master manufacturing records and batch production records are reviewed and approved, the dietary supplement is packaged and labeled as specified in the master manufacturing record, and returned dietary supplements are properly handled. (See 21 CFR part 111, subpart F.) Once you have established your written quality control procedures you must implement quality control operations, as required by 21 CFR During the inspection, you informed our investigator your firm is a distributor of your Rock Solid Nutrition brand dietary supplements and you have entered into agreements with manufacturers ( contract manufacturers ) to manufacture, package, and label your dietary supplement products. As a distributor that contracts with other manufacturers to manufacture, package, and label dietary supplements that your firm releases for distribution under your firm s brand name, FDA considers you to be ultimately responsible for the dietary supplements you introduce or deliver for introduction into interstate commerce. Although your firm may contract out dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure 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 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, delivering for introduction, or causing the delivery or introduction into interstate commerce of a dietary supplement that is adulterated under section 402

3 (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 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. As a distributor, you have an obligation to know what and how manufacturing activities are performed so 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. Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution. See 21 CFR (h). We have reviewed your response dated July 26, 2016 which included procedures for quality control within the Receiving and Returns procedures. However, we have determined these procedures are not adequate or specific enough to meet the requirements in 21 CFR because they did not address how quality control will ensure that reserve samples are collected and held, all established specifications are met, master manufacturing records and batch production records are reviewed and approved, and the dietary supplement is packaged and labeled as specified in the master manufacturing record. We also note the Returns procedure did not include the return document which is referenced in the procedure for our review. 2. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR Specifically, you did not have written procedures for holding and distributing operations of the dietary supplements you distribute. We have reviewed your response dated July 26, 2016 which included procedures for holding and distributing. However, we have determined your procedures are not adequate because your distributing procedures did not include details on the appropriate conditions for temperature, humidity, and light so the identity, purity, strength, and composition of the dietary supplements are not affected [21 CFR ], how you will hold reserve samples of dietary supplements [21 CFR ], how you will distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration [21 CFR ], and how product distribution records will be kept and maintained [21 CFR ]. Misbranded Dietary Supplements Your Whey Isolate (Cinnabun flavor), Pre-Pump (Massive Mango flavor), and Strength Test products are misbranded dietary supplement under section 403 of the Act [21 U.S.C. 343] because the products do not comply with the labeling requirements for dietary supplements. The inspection revealed the following violations of labeling requirements for dietary supplement: 1. Your Whey Isolate and Pre-Pump products are misbranded within the meaning of section 403 (q)(1)(a) of the Act [21 U.S.C. 34(q)(1)(A)] because the serving size declared on the label 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), 21 CFR (b) (1), and 21 CFR (b), Table 2. The serving size must also be expressed in a common household measure that is appropriate to the food.

4 Specifically, the directions of use suggest the consumer take 1-2 scoops, but the serving size for the Whey Isolate product lists 1 scoop, and the serving size for the Pre-Pump product lists 7.6 grams. The serving size listed should be 2 scoops. Additionally, the Pre-Pump serving size is not expressed in common household measure. It is unclear whether 7.6 grams of Pre-Pump is equivalent to 1 scoop or 2 scoops. For your Whey Isolate product, in addition to the serving size being incorrect, the number of servings noted along with the serving size of 32g does not correspond to the net contents of the product. 2. Your Whey Isolate, Pre-Pump, and Strength Test 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 Specifically, Your Strength Test and Pre-Pump products fail to identify the source ingredient that supplies a dietary ingredient within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words as or from or listed in an ingredient statement, as required by 21 CFR (d). For example, your Strength Test product lists the ingredient Vitamin D and your Pre-Pump product lists the ingredient theobromine, however, the source ingredients for these ingredients were not identified. Your Strength Test product lists both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Zinc, Vitamin D) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (e.g., DHEA, Fenugreek, D-Aspartic Acid) as defined under 21 CFR (b)(2) and (b)(3), respectively. However, the label does not segregate the 21 CFR (b)(2) and (b)(3) dietary ingredients into separate sections of the supplement facts panel as required by 21 CFR (b)(3)(i). Additionally, heavy bars are required immediately after the listing of the last dietary ingredient required to be declared pursuant to 21 CFR (b)(2) and (b)(3), respectively (21 CFR (e)(6)(ii) and (iii)). Your Whey Isolate product fails to include a symbol in the % Daily Value column horizontal to the term Proprietary Protein Matrix blend, that links to the same symbol preceding the footnote Daily Value not established, as required by 21 CFR (c)(3). Your Whey Isolate product label incorrectly declares Vitamin A, C, and D at daily values less than 2 percent on the label. Any 21 CFR (b)(2)-ingredients that are not present, or are present in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2% of the RDI for vitamins and minerals), in accordance with 21 CFR (b)(2)(i). For your Strength Test product, the percentage DV for Vitamin D is incorrect. We note a product label may continue to use the 1993 RDIs for vitamins and minerals until July 26, 2017; or a product label may use the revised RDIs as published on May 27, Your Strength Test product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because the label fails to declare each ingredient as required by 21 CFR 101.4(a) and 21 CFR 101.4(g). For example, this product is manufactured into capsules, but the label fails to declare capsule ingredients and the term DHEA for the Strength Test product needs to be spelled out, as this is not the common or usual name of the ingredient.

5 4. Your Strength Test product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which the fenugreek ingredient is derived in accordance with 21 CFR 101.4(h). The above violations are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure all of your firm s products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to promptly correct the violations may result in legal action without further notice including seizure or injunction. You should within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. In addition to the violations noted above, we have the following comments: We note that Other Ingredients list for the Pre-Pump product shall be located immediately below the nutrition label (Supplement Facts), which would be after the *Daily Value Not Established statement. You informed our investigator during the inspection that you provide design and content guidance to the company which produces the labels for your dietary supplement products. The labels are sent to your contact manufacturer, which applies them to the dietary supplement packaging. You are responsible for ensuring there are specifications for the labels and the labels conform to those specifications before they are used in the manufacture of your dietary supplements. 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 non-compliance 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 response should be sent to Andrew A. Hoopes, Compliance Officer, at 210 Walnut St., Suite 369, Des Moines, IA If you have any questions about this letter, please contact Mr. Hoopes at ext or him at andrew.hoopes@fda.hhs.gov. (mailto:andrew.hoopes@fda.hhs.gov) Sincerely, /S/ Cheryl A. Bigham -S District Director

6 Kansas City District More in 2016 (/ICECI/EnforcementActions/WarningLetters/2016/default.htm)