Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458141.htm
Timestamp: 2019-04-20 16:21:12+00:00

Document:
New Dawn Nutrition, Inc. New Dawn Nutrition, Inc. New Dawn Nutrition, Inc.
On December 16 through 30, 2014, an investigator from the United States Food and Drug Administration (FDA) inspected your facilities located at 14440 F Street, Suite 111, Omaha, NE 68137, 304 Olson Dr. Suite 103, Papillion, NE 68046, and a warehouse at 14503 Grover St., Suite 105, Omaha, NE 68144. Based on the inspection, we found 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 home page at www.fda.gov.
Your products, “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon) and “NDN Ares Black” (Orange Overdose),are labeled and/or offered for sale as dietary supplements. The Supplement Facts panel on your product labels declare dimethylamylamine as a dietary ingredient under the name “1,3 Dimethylamylamine.” Through analysis of your products, “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon) and “NDN Ares Black” (Orange Overdose), we determined these products actually contain dimethylbutylamine. This ingredient is also called, among other names, 1,3-Dimethylbutylamine, DMBA, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA.
The term “dietary supplement” is defined in section 201(ff) of the Act [21 U.S.C. § 321(ff)]. Assuming that DMBA meets the definition of a “dietary ingredient” under section 201(ff)(1), it would also be a “new dietary ingredient” for which a notification is required under section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6.
To the best of FDA’s knowledge, there is no information demonstrating that DMBA 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, DMBA 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 DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, “NDN Ares Battle Ready Pre Workout” and “NDN Ares Black” 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)] because they contain 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 a product 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 DMBA will reasonably be expected to be safe as a dietary ingredient.
It has come to our attention that DMBA used in products in the dietary supplement marketplace may be produced synthetically. Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)] defines “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. Synthetically produced DMBA is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced DMBA is not commonly used as human food or drink; therefore, it is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, synthetically produced DMBA is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient. Therefore, synthetically produced DMBA is not a dietary ingredient as defined in section 201(ff)(1) of the Act.
We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your “NDN Ares Battle Ready Pre Workout” and “NDN Ares Black” products or other products marketed by your firm that contain DMBA. 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.
During the inspection, you informed our investigator that your firm is a labeler and an own-label distributor of your NDN New Dawn Nutraceuticals brand dietary supplements that has entered into agreements with contract manufacturers to manufacture your dietary supplement products. As an own-label distributor that contracts with other manufacturers to manufacture dietary supplements that your firm labels and releases for distribution under your firm’s brand name, FDA considers you to be a manufacturer of such dietary supplements. You have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.
Your “NDN FA Prime Super Protein” (Blueberry Pie), “NDN FA Prime Pure Super Protein” (Cake Batter), “NDN FA Prime Pure Super Protein” (Vanilla Milkshake), “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze) 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 (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
1. You failed to establish specifications that provide sufficient assurance that the product you receive from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
Specifically, you acknowledged to our investigator, that your firm did not currently have written procedures at your firm for quality control operations to evaluate incoming products against predetermined specifications. In addition you acknowledged to our investigator that your firm does not perform any analytical testing of incoming dietary supplements you receive for packaging and labeling.
2. You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications to ensure that you that you applied the specific label, as required by 21 CFR 111.70(g). Specifically, during the inspection our investigator found your firm does not have written specifications with which to compare your finished products after you have applied labels to containers of your dietary supplement products. Further, once you have established specifications, you must determine whether those specifications have been met as required by 21 CFR 111.73 and in accordance with 21 CFR 111.75. We note that you failed to ensure that “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (all flavors) and “NDN Ares Black Signature Edition” (all flavors) were labeled correctly. For example, the current label on the “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze) dietary supplement products indicate the products contain 1,3 Dimethylamylamine HCl (DMAA). However, through analysis of your products “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon) and “NDN Ares Black” (Orange Overdose), we determined these products contain DMBA that is not declared on the label. Further, you informed our investigator on 12/19/14 that “NDN Ares Black” (Orange Overdose) and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze) products instead contain Amperall, even though the product labels listed DMAA as an ingredient and not Amperall.
3. You failed to establish and follow written procedures for the responsibilities of quality control operations, as required by 21 CFR 111.103. Specifically, during the inspection our investigator found your firm failed to have a written procedure to review incoming dietary supplements from contract manufacturers marketed under the brand “NDN New Dawn Nutraceuticals” label. Examples of these products include, but are not limited to, “NDN FA Prime Super Protein” (Blueberry Pie), “NDN FA Prime Pure Super Protein” (Cake Batter), “NDN FA Prime Pure Super Protein” (Vanilla Milkshake), “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze).
4. You failed to identified personnel to be responsible for your quality control operations, as required by 21 CFR 111.12(b). Specifically, during the inspection our investigator found your firm failed to identify personnel responsible for performing quality control operations for incoming dietary supplements from your contracted manufacturers of dietary supplements marketed under the brand “NDN New Dawn Nutraceuticals” label. Examples of these products include, but are not limited to, “NDN FA Prime Super Protein” (Blueberry Pie), “NDN FA Prime Pure Super Protein” (Cake Batter), “NDN FA Prime Pure Super Protein” (Vanilla Milkshake), “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze).
5. You failed to identify each unique lot within each unique shipment of received product in a manner that allows you to trace the lot to the supplier and the date received, as required by 21 CFR 111.165(d)(1). Specifically, during the inspection our investigator found your firm failed to apply a unique identifier (lot number) to dietary supplements labeled and distributed under your brand “NDN New Dawn Nutraceuticals”. Examples of these products without unique identifiers include, but are not limited to, “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze).
6. You failed to establish and follow written procedures for labeling operations, as required by 21 CFR 111.403. Specifically, during our inspection you acknowledged to our investigator that you do not have procedures for the labeling operations at your firm. In addition, you must make and keep records of the written procedures for labeling operations in accordance with the record-keeping regulations at 21 CFR 111.605 and 21 CFR 111.610 [21 CFR 111.430].
7. In addition, you failed to prepare a batch production record every time you manufacture a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, you failed to prepare a batch record that includes documentation, at the time of performance, of labeling operations for your dietary supplement products, including, but not limited to “NDN FA Prime Super Protein” (Blueberry Pie), “NDN FA Prime Pure Super Protein” (Cake Batter), “NDN FA Prime Pure Super Protein” (Vanilla Milkshake), “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze).
1. Your “NDN FA Prime Super Protein” products in Blueberry Pie, Cake Batter, and Vanilla Milkshake varieties are misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false and misleading. FDA analyzed samples of your “NDN FA Prime Super Protein” products in Blueberry Pie, Cake Batter, and Vanilla Milkshake varieties and found the amount of protein present is less than the amount declared and the amount of sugar present is more than the amount declared.
· Analysis reveals the protein content is 21.3% (original analysis) and 24% (check analysis) of the value declared on the product label.
· Analysis reveals the sugar content is 1814% (original analysis) and 1710% (check analysis) of the value declared on the product label.
· Analysis reveals the protein content is 16.6% (original analysis) and 16% (check analysis) of the value declared on the product label.
· Analysis reveals the sugar content is 846% (original analysis) and 932% (check analysis) of the value declared on the product label.
· Analysis reveals the protein content is 11.9% (original analysis) and 16.1% (check analysis) of the value declared on the product label.
· Analysis reveals the sugar content is 836% (original analysis) and 918% (check analysis) of the value declared on the product label.
2. Your “NDN FA Prime Pure Super Protein” products in Cake Batter and Vanilla Milkshake varieties are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your products are manufactured with “Splenda,” which is a multi-component ingredient; however, you fail to list all the sub-ingredients on your finished product label.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
3. Your “NDN Ares Black Signature Edition” product in the Loki’s Lemonade Kraze variety is misbranded under section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the label does not provide the net quantity of contents, as required under 21 CFR 101.105(a).
Additionally, your “NDN FA Prime Pure Super Protein” products in Blueberry Pie, Cake Batter and Vanilla Milkshake varieties, “NDN Ares Battle Ready Pre Workout (Warpath Watermelon), and “NDN Ares Black” (Orange Overdose) labels failed to include the term “net weight” when stating the net quantity of contents in terms of weight, in accordance with 21 CFR 101.105(j)(3).
4. Your “NDN FA Prime Pure Super Protein” products in Blueberry Pie, Cake Batter and Vanilla Milkshake varieties 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 labels failed to present nutrition information on the nutrition label using the “Supplement Facts” title in accordance with 21 CFR 101.36(e).
5. Your “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze) product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because it does not include a statement of identity as a “dietary supplement,” as required by 21 CFR 101.3(g).
In addition, the Food and Drug Administration has determined that your facility at 14503 Grover St., Suite 105, Omaha, NE 68144 is subject to the (b)(3) of the (b)(3) and our implementing regulation at (b)(3). The (b)(3) FDA.
This letter may not list all the violations at your facility. The above list is not intended to be an all-inclusive list of deficiencies with your products, labels, and labeling. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Your “NDN Ares Battle Ready Pre Workout” (Warpath Watermelon), “NDN Ares Black” (Orange Overdose), and “NDN Ares Black Signature Edition” (Loki’s Lemonade Kraze) products failed to declare the quantitative amounts by weight per serving of dietary ingredients using metric measures in appropriate units (i.e. 1,000 or more units shall be declared in the next higher set of units, e.g. 1,100 mg shall be declared as 1.1g) in accordance with 21 CFR 101.36(b)(3)(ii)(A).
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your response should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Suite 205, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Jessica E. Hensley at 913-495-5183.

References: § 321
 § 350
 § 350
 § 342
 § 342
 § 331
 § 321
 § 342
 § 343
 § 343
 § 343
 § 343
 § 343
 § 379
 § 379