Bradley N. Howard
- Genetic Edge Compounds LLC
McKinney, TX 75070
- Issuing Office:
- Dallas District Office
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Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
April 14, 2017
Bradley N. Howard, Owner and CEO
Genetic Edge Compounds, LLC
McKinney, Texas 75070
From August 19 through September 1, 2016, the U.S. Food and Drug Administration (FDA) inspected your facility located at (b)(6), (b)(7)(C), McKinney, 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 regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your 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 your product labels and your websites at www.geneticedgecompounds.net and www.gecdirect.com. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your websites at the Internet addresses www.geneticedgecompounds.net and www.gecdirect.com in December 2016 and has determined that you take orders there for the products “Innersteel NST,” “Revitastane PCT,” “NG Nitroglide,” “Test MD,” “LX Laxoplex Figure,” “LX Laxoplex,” and “XR Neurospike.” The claims on your websites establish that the products 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. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
- “Milk thistle – used as a natural treatment for liver problems….helps repair liver cells damaged by alcohol and other toxic substances.”
- “N-acetyl L-cysteine…plays a role in white cell production which may help repair damaged tissue.”
- “Alpha Lipoic Acid…may also be helpful in certain liver diseases.”
- “Chinese skullcap…helpful in preventing heart disease and limiting the damage to the heart following a heart attack. It is also used to combat high cholesterol, triglycerides, and high blood pressure.”
- “Artichoke leaf…used for high cholesterol, kidney and liver problems, and lowering blood pressure.”
- “Hawthorn berry – used to…treat angina, high blood pressure, congestive heart failure and cardiac arrhythmia…”
- “Milk Thistle, NAC, and ALA repair damaged liver cells…”
- “Artichoke, Skull Cap, and Hawthorn[e] berry aid in preventing heart disease, combat high blood pressure, and lower cholesterol…”
- “Mucuna Pruriens – has been used for treating make sexual dysfunction…found to have antidepressant properties in cases of depressive neurosis…”
- “Inflammation reduction”
- “[N]ot only maintain but repair and aid in the regeneration of overworked joints”
- “[R]epair and maintain overworked joints.”
- “[D]ecreases the amount of testosterone in men putting them at risk for many unwanted side effects such as depression… “
LX Laxoplex Figure
- “[R]epair broken down muscle cells, and provide anti-inflammation benefits for lean mass…”
- “[R]epair broken down muscle cells, and provide anti-inflammation benefits for lean mass…”
- “Neurospike TM is a perfect blended matrix of nootropics aka smart drugs …”
Your products 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 new drugs 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 “Intersteel NST,” “Revistastane PCT,” and “Test MD” 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, “Intersteel NST,” “Revistastane PCT,” and “Test MD” 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
The August 19 through September 1, 2016, inspection of your facility revealed the following significant violations of the cGMP requirements for dietary supplements. These violations cause your Genetic Edge Compounds dietary supplement 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.
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, you have an obligation to know what and how these activities are performed so you can make decisions related to whether the products conform to established specifications and whether to approve and release products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure all phases of the production of that product complies with dietary supplement cGMP requirements.
Although your firm may contract out certain dietary supplement manufacturing 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. 2747, 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 with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations is responsible for ensuring the product is not adulterated for failure to comply with dietary supplement cGMPs, regardless of who actually performs the operations.
The following cGMP violations were observed during the inspection:
1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 111.140(b)(1). Specifically, you have not established any written procedures for quality control operations, and you do not perform quality control functions, such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications.
Once you have established your quality control written procedures, you must implement quality control operations in your holding operations, as required by 21 CFR 111.65, and you must implement a system of production and process controls to ensure the quality of the dietary supplements, as required by 21 CFR 111.55.
We have reviewed your response letter, dated September 16, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response states that you have amended your Genetic Edge Compounds Procedures to include quality control functions and that you have established an Out Of Specification sheet to work with your contract manufacturer to investigate and document any out of specification results from a production run. However, the procedure you provided in your response does not include specific requirements your quality control personnel must comply with and does not provide any documentation regarding specific quality control procedures you have implemented to ensure that all products you release into commerce are manufactured to ensure that they conform to established specifications.
2. 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 any of the dietary supplement labels that you design and distribute under your Genetic Edge Compounds dietary supplement brand name.
We have reviewed your response letter, dated September 16, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response letter states you will establish label specifications for all of your brand name dietary supplements, and that you will maintain a “standard label book” for all labels each time you order new labels from your printing company. However, you have not provided label specifications with which we can evaluate your firm’s compliance with the regulation.
3. Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). Specifically, your firm has been distributing dietary supplements since 2012, but you have not collected and held reserve samples of the products distributed. 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). Specifically, the reserve samples that you maintain must:
- Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].
- Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].
- Be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample [21 CFR 111.83(b)(3)].
- Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications [21 CFR 111.83(b)(4)].
We have reviewed your response letter, dated September 16, 2016, but we are unable to evaluate the adequacy of your corrective action. Your response states that you have amended your Genetic Edge Compounds Procedures to include a section on Retain Samples that provides that you will collected a sample from the (b)(4) of a pallet received at your facility prior to receiving the product into inventory for distribution. Your response also explains that:
- For (b)(4) orders you will (b)(4) in addition to performing a visual inspection for the label appearance, seal integrity and lot number legibility prior to receiving the product into inventory;
- Samples will be logged into the retain log and stored in a (b)(4) room in the facility; and
- Retain samples will be kept for at least (b)(4) after the expiration date.
Your response did not provide evidence to demonstrate whether and how this procedure has been implemented. It also fails to explain how you intend to satisfy the requirement in 21 CFR 111.83(b)(4) that you hold at least twice the quantity needed for tests or examinations. Further, your response fails to explain how many samples you are required to hold according to your procedure.
4. You failed to establish written procedures to fulfill the requirements for product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. The written procedures you have established for product complaints fail to satisfy the requirements of 21 CFR 111, Subpart O. Specifically, your written procedures fail to:
- Specify that a qualified person will review all product complaints to determine if the complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR 111 [21 CFR 111.560(a)(1)].
- Ensure that a qualified person will investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury [21 CFR 111.560(a)(2)].
- Ensure that quality control personnel will review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed [21 CFR 111.560(b)].
- Specify that the review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and follow-up action of any investigation performed, extends to all relevant batches and records [21 CFR 111.560(c)].
Once you have established the procedures as required under 21 CFR 111.553 and 21 CFR 111.560, you must make and keep records of product complaints, as specified under 21 CFR 111.570.
Misbranded Dietary Supplements
Even if your Genetic Edge Compounds product labeling and websites did not contain claims that cause some of your products to be unapproved new and misbranded drugs, they would still be misbranded foods under section 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101, as follows:
1. Your “AD Adonis Apple Candy,” “Innersteel NST,” “NG Nitroglide,” and “Test MD” 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. These labels for these products do not have a complete address or a phone number.
2. Your “AD Adonis Tropical Punch” and “AD Adonis Apple Candy” 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 does not comply with 21 CFR 101.36. Specifically, the product labels list chloride in the wrong order. Chloride, its quantitative amount by weight per serving, and percent of the daily value, should be listed just before sodium in accordance with 21 CFR 101.36(b)(2)(i)(B).
3. Your “Test MD” 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 each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure your establishment is 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 take appropriate corrective actions may subject your firm and products to further actions, such as injunction or seizure.
We offer the following comments:
1. Your “AD Adonis Tropical Punch” and “AD Adonis Apple Candy” products bear the following statement: “Daily Value based on a 2000 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).
2. The label shown on your “NTC Nitrocell” product fliers bears the name “Witamin E TPGS”. We believe this ingredient is misspelled and also note that it is not the common or usual name which is required in the listing of food ingredients. We also note that if this ingredient is serving as a source of Vitamin E, it may not be listed in the Supplement Facts label when the amount of Vitamin E is less than 2% RDI per serving. As we are not certain as to the intended use of this ingredient, we note that if it is not acting as a source of Vitamin E, its intended use may be as a food additive, in which case it should be listed in the ingredient list rather than in the Supplement Facts label.
3. The label shown on your “AS Anabolik Shock,” “TNT Thermanite,” “XR Neurospike,” “OX Omnadex,” and “NTC Nitrocell” product fliers bears abbreviations which are not the common or usual names; for example, GABA, EGCG, AKG, GPC, OPC, TPGS (as noted above), and ALA, to comply with 21 CFR 101.36(b)(3) and 21 CFR 101.4.
4. The label shown on your “TNT Thermanite” product flier declares vitamin B6 and niacin as part of the Thermanite Blend. These (b)(2)-dietary ingredients cannot be declared in the supplement facts label unless they are present in amounts of at least 2% RDI per serving to comply with 21 CFR 101.36(b)(2)(i).
5. The label shown on your “AS Anabolik Shock” product flier bears Other Ingredients within the Supplement Facts label. The ingredient list must be separate from the Supplement Facts to comply with 21 CFR 101.4(g).
6. The label shown on your “TNT Thermanite” product flier declares “Proven ingredients combined with the most innovative API’s make Thermanite the most effective fat burner on the market.” It is not clear what the acronym “API” refers to in this statement.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documents. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-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.
Shari J. Shambaugh
Acting Dallas District Director
Texas Department of State Health Services
Lori Woznicki, M.P.H.
Food and Drug Inspection Branch Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756
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