From May 25 to June 16, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 660 Hembree Parkway in Roswell, GA. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations render your dietary supplements adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)], in that the products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. The inspection also revealed violations of dietary supplement labeling requirements, rendering your DTF, Gym Candy, and Biotech Underground products misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)]. These products include, but are not limited to, your DTF brand products CLA FUEL™, JOINT FUEL™, DHEA FUEL™, and PUMP FUEL™; your Gym Candy brand products Lift Candy and Pump Candy; and your BioTech Underground products Purify™ and Tudca™. You may find the Act and pertinent FDA regulations through links on FDA's website at
www.fda.gov.
Furthermore, FDA confirmed through laboratory analysis that your Tri-ton product contains ostarine and andarine, which are selective androgen receptor modulators (SARMs). We acknowledge that your firm voluntarily recalled Tri-ton in May 2017; this letter emphasizes significant safety concerns about Tri-ton, which is marketed as a dietary supplement but is actually an unapproved new drug and misbranded drug. Life-threatening reactions have occurred with the use of SARMs, including liver toxicity. SARMs also have the potential to increase the risk of heart attack and stroke.
Dietary Supplement CGMP Violations
The significant violations of dietary supplement CGMP requirements identified during the May 25 to June 16, 2017, inspection include, but may not be limited to, the following:
1. Your quality control personnel failed to ensure that your 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, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [see 21 CFR 111.105(a)]. Additionally, the personnel you identified to perform quality control operations do not have the education, training, or experience to perform quality control functions, as required by 21 CFR 111.12(c). Specifically, you identified yourself to our investigator as the quality manager, but admitted that you were not familiar with the Dietary Supplement GMPs and had not received any training to perform the duties associated with quality control.
To fulfill the requirements for quality control operations, your firm must 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. You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your written response provides your quality control operations SOP, which you state were "finalized" on June 20, 2017, and which "will be implemented . . . over the next 90 days." However, you provided no documentation to demonstrate that you have implemented the procedures. We will verify the sufficiency of your corrective action during our next inspection. Your response also does not address our concerns regarding your ensuring that the quality control unit consists of personnel qualified through education, training, or experience to perform the necessary duties or provide adequate evidence of their implementation. During the inspection, you indicated to our investigator that you planned to hire a qualified quality unit manager, but your response does not provide evidence that you have hired a qualified quality unit manager.
2. Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205. Specifically, you did not prepare a written MMR for any unique formulation of dietary supplement that you manufacture, and for each batch size.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states that you "finalized and implemented immediately" your master manufacturing records SOP, and you provided a copy of the finalized SOP; however, you did not provide a written master manufacturing record (MMR) for each unique formulation of dietary supplement, as required by 21 CFR 111.205.
3. Your firm failed to prepare a batch production record every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you did not prepare batch production records for any of the dietary supplements you manufactured.
As required by 21 CFR 111.260(a) - (n), the batch production records you establish must include the following:
a. The batch, lot, or control number of the finished batch of dietary supplement;
b. The identity of equipment and processing lines used in producing the batch;
c. The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained;
d. The unique identifier that you assigned to each component (or when applicable, to the product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used;
e. The identity and weight or measure of each component used;
f. A statement of the actual yield and statement of the percentage of theoretical yield at appropriate phases of processing;
g. The actual results obtained during any monitoring operation;
h. The results of any testing or examination performed during the batch production, or a cross-reference to such results;
i. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g);
j. Documentation, at the time of performance, of the manufacture of the batch, including:
a. The date on which each step of the master manufacturing record was performed; and
b. The initials of the person responsible for weighing or measuring of each component used in a batch; and
c. The initials of the person responsible for verifying the weight or measure of each component used in the batch; and
d. The initials of the person responsible for adding the component to the batch; and
e. The initials of the person responsible for verifying the addition of components into a batch;
k. Documentation, at the time of performance, of packaging and labeling operations including:
a. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and reconciliation of any discrepancies between issuance and use of labels; and
b. An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record;
l. Documentation, at the time of performance, that quality control personnel review the monitoring operations;
m. Documentation, at the time of performance, of any required material review and disposition decision;
n. Documentation, at the time of performance, of any reprocessing.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your written response indicates that you "finalized and implemented immediately" your batch production records SOP, and you provided a copy of the finalized SOP. You did not provide supporting documentation such as a copy of a completed batch production record with your response.
4. Your firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically, you have not established any written specifications for your dietary supplement products.
As required by 21 CFR 111.70(b) - (g), you must (among other requirements):
b. Establish specifications for each component you use in the manufacture of a dietary supplement;
c. Establish in-process production specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements;
d. Establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications);
e. Establish 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 adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement;
f. If you receive a product for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order; and
g. Establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label.
Once you have established the aforementioned specifications, you must determine whether those specifications have been met, as required by 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records for established specifications, as required by 21 CFR 111.95.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your written response indicates that you "finalized and implemented immediately" your specifications SOP, and you provided a copy of the finalized SOP. However, you did not provide with your response any copies of the required specifications for each of the dietary supplement products you manufacture or for the components or the labels and packaging used in the manufacture of your dietary supplements. A generalized SOP is insufficient to demonstrate that you have created a specification for each dietary supplement, component of each dietary supplement, label, and packaging used in the manufacture of your dietary supplement.
5. Your firm failed to identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component; and to the dietary supplement you manufactured and distributed, as required by 21 CFR 111.155(d)(1). Specifically, your failure to prepare and maintain batch production records and to identify each unique lot within each unique shipment prevents you from being able to trace the components you use through all stages of production and distribution. In addition, the finished dietary supplements were not identified with unique manufacturing codes.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your written response indicates that you "finalized" and "will implement over the next 90 days" your SOP covering the tracking of raw material components, packaging components, labels, and products received for packaging or labeling as dietary supplements. You also provided a copy of the finalized SOP. You did not provide supporting records to show that you implemented this requirement. We will verify the sufficiency of your corrective action during our next inspection.
6. Your firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, your firm does not collect reserve samples of any of the dietary supplements you distribute.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your written response states that you "finalized and implemented immediately" your representative and reserve sample SOP and you provided a copy of the finalized SOP. You did not provide any additional supporting documentation, such as photographs or other evidence of the reserve samples you have taken, to indicate that your firm has implemented these procedures.
7. Your firm failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR 111.14(b)(2). Specifically, you were unable to produce training records for the
(b)(4) employees who were observed engaged in manufacturing operations on May 31, 2017.
We have reviewed your response letter dated July 6, 2017; however, we are unable to evaluate the sufficiency of your corrective actions. Your written response states that you
"finalized and immediately implemented" your employee training SOP, and you provided a copy of the finalized SOP. You did not provide any additional supporting documentation, such as completed employee training records, to indicate that your firm has implemented these procedures.
Misbranded Dietary Supplement Violations
We reviewed the labeling of your Lift Candy, Pump Candy, Clafuel, Joint Fuel, DHEA fuel, Pump Fuel, OMEGA fuel, Night fuel, Organ fuel, Purify and Tudca products and found that these dietary supplements are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to identify a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event regarding a dietary supplement. Currently, your labels display a telephone number that connects consumers to a voice recording providing information on FDA's MedWatch Program. Your firm is responsible for the manufacture and distribution of dietary supplements. Consumers must be able to contact you or another responsible person at your firm should a serious adverse event occur. Further, the product labels display an address that is your firm's previous mailing address and not your current one. As required by 21 CFR 101.5, you must list the street address, if it is not listed in a current city directory or telephone book, along with the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address. Your current address is not listed in a current city directory or telephone book; therefore, you are required to ensure that the labels for your dietary supplement labels list your firm's current contact information.
Your OmegaFuel product label declares fish oil, but fails to declare the major food allergen "fish" as required by section 403(w)(1) of the Act. Specifically, the label fails to declare the species and type of fish, as provided under the Food Allergen Labeling and Consumer Protection Act (FALCPA).
Your Purify, NightFuel, DHEA Fuel, and Joint Fuel product labels are misbranded under Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that each label does not identify the part of the plant of the botanical dietary ingredients.
Your JointFuel, DHEAFuel, and OmegaFuel products are misbranded within the meaning of Section 403(i)(2) of the Act in that the products labels fails to declare all the common or usual names of each ingredient used and/or its source as required by 21 CFR 101.36(d) and 21 CFR 101.4. For example,
- Your JointFuel product label declares glucosamine, chondroitin, and collagen II, but fails to identify the source of those ingredients.
- Your ClaFuel product label fails to identify the source of the conjugated linoleic acid oil.
- Your DHEAFuel and OmegaFuel products list terms such as Super Ra DHEA, EPA, or DHA which need to be spelled out.
Your ClaFuel, and DHEAFuel, and OMEGAFuel products are misbranded under 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 the product does not comply with 21 CFR 101.36. For example,
- For your ClaFuel product label, calories must be expressed to the nearest 5-calorie increment up to and including 50 calories. In addition, a statement of the number of grams of total fat per serving must be expressed to the nearest .5 gram increment below 5 grams, as required by 21 CFR 101.9(c)(1).
- Your DHEAFuel product label lists 50 mg of Free Testosterone Accelerator along with 3,4-divanillytetrahydrofuran 95%. However, this declaration implies there are either other ingredients in the Accelerator mixture or the 95% declaration is referring to an extract from some other source. The nutrition information should accurately inform the consumer.
- For your OMEGAFuel product label, a symbol that links to "Daily Value not Established" must be placed in the column %DV and lateral to the amount of polyunsaturated fat declared, as required by 21 CFR 110.36(b)(3)(iv).
Your ClaFuel, JointFuel, DHEAFuel, PumpFuel, OmegaFuel NightFuel, and OrganFuel, products are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. § 343(e)(2)] in that the product labels do not provide the net quantity of contents in accordance with 21 CFR 101.7. The net contents statement must be placed on the principal display panel within the bottom 30 percent of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed.
Your ClaFuel, JointFuel, DHEAFuel, PumpFuel, OmegaFuel, NightFuel, and OrganFuel products are misbranded within the meaning of Section 403(f) of the Act [21 U.S.C. § 343(f)] because each product label does not prominently place the statement of identify with conspicuousness in accordance with 21 CFR 101.3(d).
Unapproved New Drug and Misbranded Drug Violations
Tri-ton is labeled as a dietary supplement on its label and other labeling; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)]. Tri-ton is labeled to contain the SARM MK-2866 (also known as ostarine). According to section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(ii)], the definition of a dietary supplement does not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug. Ostarine has been authorized for investigation as a new drug and is the subject of substantial clinical investigations, which have been made public,
[1] Therefore, Tri-ton is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. and ostarine was not marketed as a dietary supplement or as a food until after it was authorized for investigation as a new drug.
Under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)], drugs are defined as articles (other than foods) that are intended to affect the structure or function of the body. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution [21 CFR 201.128]. Your product labeling includes a claim that indicates the intended use of the product, such as "Physique Enhancing Agent." This claim established that your product Tri-ton is a drug under section 201(g)(1)(C) of FD&C Act because it is intended to affect the structure or function of the body.
Moreover, the product is a "new drug," as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321 (p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
Furthermore, your products is a "prescription drug" as defined at section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], in that because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Life threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke. The long-term safety profile of SARMs remains unclear; more clinical evidence is necessary to alleviate critical safety concerns such as liver toxicity, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
The introduction or delivery for introduction, or causing the introduction or delivery for introduction, of any new drug lacking an FDA-approved new drug application (NDA) is a violation of sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)]. Your sale of the new drug Tri-ton without an approved NDA violates these provisions of the FD&C Act.
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR 201.5]. Because, by definition, prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner,
see section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)A)], adequate directions for use cannot be written so that a layperson can use them safely for their intended uses. Consequently, the labeling fails to bear adequate directions for its intended uses, causing Tri-ton to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
FDA has exercised its authority under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] to create regulatory exemptions from the requirements of section 502(f)(1) [21 U.S.C. § 352(f)(1)]. Among the terms that must be met to satisfy these regulatory exemptions, a prescription drug must have labeling that provides adequate information for its safe and effective use by practitioners for each of the purposes for which it is intended, including all purposes for which it is advertised or represented [21 CFR 201.100(c)(1) and 201.100(d)].
Because your firm's Tri-ton product lacks the required approved application, it is not exempt under 21 CFR 201.115 from the requirement to bear adequate directions for use under section 502(f)(1) of the FD&C Act. Therefore, the product is misbranded, and the introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of this misbranded product violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
The above is not intended to be an all-inclusive list of violations in connection with your products or your firm. You should take prompt action to correct all noted violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations. Failure to correct and prevent these violations or similar ones may result in legal action without further notice to you, including, without limitation, seizure and injunction.
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
