Between February 3, 2017 and March 31, 2017, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 100 Executive Drive, Suite A, Edgewood, NY 11717. During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, and Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplements manufactured at your facility 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. We
received your firm's FDA-483 response correspondence, dated May 8, 2017. We provide comments to your response immediately following the violations addressed below.
During the inspection, our investigators collected samples of your products
1,3D Nox Xtrim Green Apple, Adrenal Pump, Shredder, and Tummy Tuck. Our analysis of these samples found that they contained 13-dimethylamylamine (DMAA), an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. Therefore, 1,3D Nox Xtrim Green Apple, Adrenal Pump, Shredder, and Tummy Tuck are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)].
In addition, in July 2017 we reviewed the labeling for your Omega-3-Fish Oil product and the webpage https://tbnlabs.com/product/total-estro-33-diindolymethane, where you take orders for your Total Estro (3,3 Diindolymethane) product. The claims on your product labeling and your website establish that Omega-3 Fish Oil and Total Estro (33 Diindolymethane) are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
FDA has also determined that your 1,3D Nox Xtrim Green Apple, Tummy Tuck, Adrenal Pump, Omega-3 Fish Oil, and Shredder products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. 343], in that their labels fail to include required information or contain false or misleading information. You can find the Act and the FDA's regulations through links on FDA's home page at
www.fda.gov.
The violations are described further below.
Adulterated Dietary Supplements: Unsafe Food Additive
During your inspection
, Investigators collected samples of the following products:
- 1,3D Nox Xtrim Green Apple, (b)(4)
- Adrenal Pump, (b)(4)
- Shredder, (b)(4)
- Tummy Tuck, (b)(4)
The products were analyzed by the FDA for the presence of DMAA. Analysis found all four products contained DMAA.
DMAA does not qualify as a dietary ingredient under section 201(ff)(1) of the Act because it is not a vitamin, mineral, amino acid, herb or other botanical, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or concentrate, metabolite, constituent, extract, or combination of any of the preceding dietary ingredient types.
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act. Adulterated foods cannot be legally imported or marketed in the United States.
Section 201(s) of the Act [21 U.S.C § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the DMAA used in your products, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.
DMAA is not generally recognized as safe under its conditions of use in your dietary supplement product. Because DMAA does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your 1,3D Nox Xtrim Green Apple, Adrenal Pump, Shredder, and Tummy Tuck products are adulterated under section 402(a)(2)(C)(i) of the Act because they contain an unsafe food additive. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)].
The FDA recognizes that your firm voluntarily destroyed 876 tubs of 1,3D Nox Xtrim Green Apple, 23 bottles of Adrenal Pump, 8 bottles of Shredder, and 11 bottles of Tummy Tuck on March 22, 2017.
Unapproved New Drug and Drug Misbranding Violations
Examples of some of the label claims that provide evidence that your Omega-3-Fish Oil is intended for use as a drug include:
- "Heart- ... helping reduce the risk of arrhythmias and sudden death by heart attack."
- "Brain - Better brain function though more efficient neurotransmitters leading to ... less likelihood of depression and reduced risk of ADHD in children."
- "Joints and Arthritis - Better joint function from reduced inflammation and a reduction in pain".
- "Immune System and Cancer - A stronger immune system, proven to be beneficial for ... lowered risk of breast and prostate cancer."
- "Digestive System- ... improving intestinal health and reducing inflammation assisting those with IBS or Crohn's Disease."
- "Diabetes - Fish oil enhances insulin secretion from beta cells in the pancreas, regulating blood sugar levels. DHA plays a protective role in diabetic neuropathy in all forms of diabetes."
Examples of some of the website claims that provide evidence that your Total Estro (33 Diindolymethane) is intended for use as a drug include:
- "DIM also exerts numerous anti-carcinogenic (anti-cancer) effects in the body ..."
Your Omega-3-Fish Oil and Total Estro (3,3 Diindolymethane) are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the
Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Omega-3-Fish Oil and Total Estro (33 Diindolymethane) are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Omega-3-Fish Oil and Total Estro (33 Diindolymethane) fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
Adulterated Dietary Supplements: CGMP Violations
1. You failed to establish specifications for the identity, purity, strength, and composition of each finished batch of each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, to ensure the quality of the dietary supplement as required by 21 CFR 111.70(e). For example, your firm has not established finished product specifications as required by 21 CFR 111.70(e) for the following products:
- 1,3D Nox Xtrim Green Apple,
- Adrenal Pump,
- Shredder,
- Tummy Tuck.
We have reviewed your response dated May 8, 2017, wherein you provided a revised Master Batch Record for 1,3D Nox Xtrim Green Apple; however, that record provided no reference to any finished product specifications. Your response also mentioned that you inspect all incoming raw materials, but that information is not relevant to establishing specifications for your finished dietary supplement products, which is a separate requirement.
Once you have established finished product specifications for your dietary supplements, you must determine whether the specifications have been met, as required by 21 CFR 111.75(c). You must also make and keep records of the specifications you establish, as required by 21 CFR 111.95(b)(1).
2. You failed to establish an identity specification for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, you have not established identity specifications for any of the dietary ingredients or other components that you are receiving and using in the manufacture of dietary supplements, including but not limited to components used in the following:
- 1,3D Nox Xtrim Green Apple
- Adrenal Pump
- Shredder
- Tummy Tuck
Once you have established component specifications and before using each component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition FDA under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing, and you must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
We have reviewed your response dated May 8, 2017, in which you say that you intend to create identity specifications for components. However, we are unable to evaluate the adequacy of your response because you have not provided documentation that you have established component specifications and are verifying that the component specifications are met before components are used.
3. You failed to establish and follow written procedures for the responsibilities of the quality control operations as required by 21 CFR 111.103, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.
We have reviewed your response dated May 8, 2017. In your response you stated that you have retrained your employees, are writing procedures for quality control operations, and will submit a copy of the procedures when they are finished. However, we are unable to evaluate the adequacy of your response at this time because you have not provided documentation of such training conducted and such written procedures.
4. You failed to establish and follow written procedures to fulfill the requirements for product complaints, as required by 21 CFR 111.553, such as the requirement in 21 CFR 111.560 to review product complaints and investigate any that involve a possible failure of a dietary supplement to meet any of its specifications.
Product complaint records must include the following; The name and description of the dietary supplement; the batch, lot, or control number of the dietary supplement, if available; the date the complaint was received and the name, address, or telephone number of the complainant, if available; the nature of the complaint including, if known, how the product was used; the reply to the complainant, if any; and findings of the investigation and follow-up action taken when an investigation is performed (21 CFR 111.570(b)(2)(ii)(A)-(F)).
We have reviewed your response dated May 8, 2017. In your response you stated that you are writing procedures for review and investigation of product complaints and will submit a copy of the procedures when they are finished. However, we are unable to evaluate the adequacy of your response at this time because you have not provided documentation of such written procedures for product complaint handling.
5. You failed to establish and follow written procedures for fulfilling the requirements for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a).
Specifically, your firm has not established written procedures for calibrating any of the scales used to weigh dietary ingredients, in process material, and finished product.
We have reviewed your response dated May 8, 2017. In your response you stated that you are in the process of establishing written procedures for calibrating instruments and controls and intend to provide the procedures to FDA when they are finished. However, we are unable to evaluate the adequacy of your response at this time because you have not provided documentation of such written procedures.
Misbranded Dietary Supplements
1. Your 1,3D Nox Xtrim Green Apple and Tummy Tuck products are misbranded within the meaning of sections 403(i)(2) and 403(q)(5)(F) of the Act [21 U.S.C. §§ 343(i)(2) and 343(q)(5)(F)] in that they are fabricated from two or more ingredients, but the labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
- Your 1,3D Nox Xtrim Green Apple product's batch production record collected during the inspection lists caffeine as an ingredient, but this ingredient is not declared on the product's label in accordance with 21 CFR 101.4(g). Additionally, the Master Manufacturing Record (MMR) for 1,3D Nox Xtrim Green Apple, provided in your May 8, 2017 response, lists Malic Acid, Dextrose Anhydrous and M100 Maltrin, but these three ingredients are not declared on the product label. These ingredients were also listed on the Batch Production Record for 1,3D Nox Xtrim Green Apple (b)(4) collected during inspection of your firm from February 3, 2017 to March 31, 2017. Finally, two ingredients listed as N, N Dimethyl HCL and Beta Phenyl Ethylamine HCL on the MMR are listed on the finished product labeling as one ingredient, N, N Dimethyl Beta Phenyl Ethylamine HCL.
- The Supplement Facts panel of your 1,3D Nox Xtrim Green Apple product label declares as dietary ingredients "Arginine AKG," "Carnosyn," "Creatine MagnaPower," "GAKIC," and "HICA," but these are not the common or usual names for these dietary ingredients. In the "Other ingredients" section of Supplement Facts, the label also declares "acesulfame K," which is not the common or usual name for that ingredient.
- Your Tummy Tuck product label declares the dietary ingredient "DMAE", but this is not the common or usual name for the dietary ingredient.
2. Your Shredder product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the label is false and misleading because it declares methylsynephrine as a dietary ingredient. As we informed you in FDA's March 31, 2016, warning letter to your firm (www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm494001.htm), methylsynephrine does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Act.
3. Your Omega-3 Fish Oil product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
4. Your 1,3D Nox Xtrim Green Apple product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and 15 USC 1453(a) of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. §1453(a)] for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce [21 CFR 101.7(b)(1)].
5. Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, Adrenal Pump, Omega-3 Fish Oil, and Shredder 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. For example:
- Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, Adrenal Pump, and Shredder product labels do not present the "other ingredients" statement outside and immediately below the supplement facts box, in accordance with 21 CFR 101.4(g).
- Your 1,3D Nox Xtrim Green Apple product label declares an amount of zero for calories, total fat, calories from fat, saturated fat, total carbohydrate, dietary fiber, sugars, and protein. In accordance with 21 CFR 101.36(b)(2)(i), any (b)(2)-dietary ingredient that is not present, or that is present in an amount that can be declared as zero under 21 CFR 101.9(c) (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals), must not be declared in Supplement Facts.
- Your 1,3D Nox Xtrim Green Apple product label lists quantitative amounts for cholesterol and sodium that are in incorrect increments, in accordance with 21 CFR 101.9(c) and 101.36(b)(2). Furthermore, the label fails to declare the percent of the Daily Value of cholesterol and sodium, in accordance with 21 CFR 101.36(b)(2)(iii).
- Your 1,3D Nox Xtrim Green Apple, Omega-3 Fish Oil, and Adrenal Pump product labels do not contain the heavy bars as required by 21 CFR 101.36(e)(6). A heavy bar shall be placed beneath the subheading "Servings Per Container," beneath the last (b)(2)-dietary ingredient to be listed, if any, and beneath the last other dietary ingredient to be listed, if any. The title "Supplement Facts" must be set to fill the full width of the nutrition label, in accordance with 21 CFR 101.36(e)(1).
- Your Tummy Tuck product label declares "chromium" as a dietary ingredient in the proprietary blend. In accordance with 21 CFR 101.36(c)(1), chromium must be declared in the (b)(2)-dietary ingredient section of the Supplement Facts, along with its quantitative amount and % Daily Value.
- Your Tummy Tuck and Shredder product labels declares a proprietary blend, its quantitative amount and ingredients, but these are not declared within the Supplement Facts label in accordance with 21 CFR 101.36(c).
6. Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, and Adrenal Pump 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 label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
7. Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, Omega-3 Fish Oil, Adrenal Pump, and Shredder products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act [21 U.S.C. § 379aa-1]) may receive a report of a serious adverse event associated with such dietary supplements. "Domestic address or domestic phone number" means a complete address or phone number.
In addition, we have the following comments on the labeling of your products:
- Your 1,3D Nox Xtrim Green Apple, Tummy Tuck, and Shredder product labels do not bear the correct text of the FDA disclaimer statement. These product labels also fail to bear a symbol next to each structure/function claim linking the claim to the disclaimer, as required by 21 CFR 101.93(c).
- Your Tummy Tuck and Shredder product labels' information panel includes ingredient information intermingled with intervening material. Under 21 CFR 101.2(e), information on the information panel must appear in one place without intervening material. An example of intervening material is the statement of "Capsules used for this product are Kosher and Halal certified. Vegetarian Society approved."
- The "Shell Ingredients" in your Omega-3 Fish Oil product must be listed as part of the Other Ingredients list. In addition, all ingredients in Other Ingredients must be listed in descending order by weight, in accordance with 21 CFR 101.4(a).
- Your Adrenal Pump product declares "Dendrobium 1%," but does not state which constituent of the botanical is 1%.
This letter is not an all-inclusive list of violations that exist at your facility or 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 your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure or injunction.
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.
Please respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the specific things you are doing to correct the violations described in this letter and to prevent similar violations from occurring in the future. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, explain the reason for the delay and state when you will correct any remaining violations.
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