Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533725.htm
Timestamp: 2019-04-22 18:39:33+00:00

Document:
The United States Food and Drug Administration (FDA) conducted an inspection of your own-label distribution facility, X2 Zero Corporation (dba X2Zero), located at 5522 Everhart Road, Suite B, Corpus Christi, TX from February 22, 2016 through March 4, 2016. We also have reviewed your product labeling and your websites at http://www.x2zero.com and http://www.361weightloss.com (redirects to http://stores.x2zero.com/).
Based on our inspection and review of your product labeling, including your firm’s websites, FDA has determined that certain products you offer for sale, including but not limited to “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” “Natural Eruption,” and “Quick Trim Slimming Gel” are unapproved new drugs under section 505(a) of the Federal Food and Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)]. These products also are misbranded drugs under sections 502 and/or 503 of the FD&C Act [21 U.S.C. §§ 352 and 353].
In addition, your dietary supplement products including, but not limited to “Colon Relief,” “Woman Revived,” “Ketone Cleanse,” “Colon Wipeout,” “T Drive,” “Thyroid Support,” “Yacon Syrup,” “X Heat,” “Coconut Oil” and “Natural Vine Multi Vitamin” are adulterated dietary supplements within the meaning of section 402 of the FD&C Act [21 U.S.C. § 342] and/or misbranded dietary supplements within the meaning of section 403 of the FD&C Act [21 U.S.C. § 343], as detailed below.
Your products “Dynamizm,” “Eradicate,” “Xerophagy,” “Exhilarate,” and “Natural Eruption,” marketed as dietary supplements, contain sibutramine. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
Under section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321 (ff)(3)(B)(ii)], a dietary supplement may 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 it was authorized for investigation as a new drug.
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985 and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of sibutramine became public. Based on the information available to FDA, sibutramine was not marketed as a dietary supplement or as a food before it was authorized for investigation as a new drug. Therefore, “Dynamizm,” “Eradicate,” “Xerophagy,” “Exhilarate,” and “Natural Eruption” cannot be dietary supplements under section 201(ff) of the FD&C Act.
In addition, your products “Salute” and “ZlimXter,” marketed as dietary supplements, contain sildenafil. Sildenafil is the active pharmaceutical ingredient in the FDA-approved drug Viagra. According to section 201(ff)(3)(B)(i) of the FD&C Act, a dietary supplement cannot contain an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Viagra as a new drug on March 27, 1998, and sildenafil was not marketed as a dietary supplement or as a food before this date. As such, “Salute” and “ZlimXter” cannot be dietary supplements under section 201(ff) of the FD&C Act.
“ZEAL XEROPHAGY is an innovative new thermogenic weight loss good. ZEAL XEROPHAGY has been formulated to work on the basis of thermogenesis – the process that heats your body which burns fat to do so. The ingredients contain compounds that are known for regulating metabolism and enable healthy weight loss. The ingredients in ZEAL XEROPHAGY suppress and control your appetite and increases lipolysis (the breakdown of stored fat) to help you shed excess fat . . . This product will maximize your fat burning results, while providing increased energy and improved alertness throughout the day . . . Revs up energy levels (without the jittery feeling) . . . Suppresses and controls appetite . . ..
In addition, your “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” “Natural Eruption,” and “Quick Trim Slimming Gel” are new drugs as defined in section 201(p) of the FD&C Act [21 U.S.C §321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C Act [21 U.S.C §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There are no approved applications on file with FDA for your “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” “Natural Eruption,” and “Quick Trim Slimming Gel.” The distribution or sale of these products in interstate commerce without such approved applications violates sections 301(d) and 505(a) of the FD&C Act.
“Dynamizm,” “Salute,” “Eradicate,” “Xerophagy,” “ZlimXter,” “Exhilarate,” and “Natural Eruption” are “prescription drugs” as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C § 353(b)(1)(A)], because, in light of their toxicity or potentiality for harmful effect, the method of use, or the collateral measures necessary for their use, each product is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. “Dynamizm,” “Xerophagy,” “Eradicate,” “Exhilarate,” and “Natural Eruption,” which contain sibutramine, are prescription drugs because prior to withdrawal of Meridia’s approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs. They also are prescription drugs because the FDA approval of Meridia was withdrawn because of serious safety risks.
In addition, “Salute” and “ZlimXter,” which both contain sildenafil, are prescription drugs because they contain at least one phosphodiesterase type-5 (PDE-5) inhibitor. All PDE-5 inhibitors which have been approved for marketing by the FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs.
Your “Dynamizm,” “Salute,” “Eradicate,” “Xerophagy,” “ZlimXter,” “Exhilarate,” and “Natural Eruption” are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. “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]. Prescription drugs can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write adequate directions for use for prescription drugs. As such, the labeling of “Dynamizm,” “Salute,” “Eradicate,” “Xerophagy,” “ZlimXter,” “Exhilarate,” and “Natural Eruption” fails to bear adequate directions for their intended uses. These products are not exempt from the requirements that their labeling bear adequate direction for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved drug applications are in effect for these products.
Under section 502(a) of the FD&C Act [21 U.S.C § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . ..” The labeling for your “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” and “Natural Eruption” fail to declare that the products contain sibutramine, desmethylsibutramine, sildenafil, thiosildenafil, sulfoaildenafil and/or phenolphthalein. These undeclared ingredients in your products may pose serious health risks to consumers which are only compounded by the fact that neither ingredient is declared on the label.
The undeclared sibutramine and/or PDE-5 inhibitors in “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” and “Natural Eruption” also cause these products to be misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C § 352(f)(2)] in that the products’ labeling lacks adequate warning for the protection of users. As previously noted, there is potential for adverse events associated with the use of sibutramine and PDE-5 inhibitors. Consumers who use “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” and “Natural Eruption” would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse event.
Because of their sibutramine content, your “Dynamizm,” “Eradicate,” “Xerophagy,” “Exhilarate,” and “Natural Eruption” are also misbranded under section 502(j) of the FD&C Act, [21 U.S.C. § 352(j)] because they are dangerous to health when used in the dosage or manner recommended in their labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke.
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded products mentioned above violates section 301(a) of the FD&C Act [21 U.S.C § 331(a)].
A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.
We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the products you offer for sale and the claims you make for your products do not cause them to violate the FD&C Act.
Our inspection of your facility also revealed a number of significant violations of Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, or Holding Operations for Dietary Supplements, 21 CFR 111, for the dietary supplement products that your firm distributes under your own various brands. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the FD&C 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 current good manufacturing practice 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 111.103. Additionally, you are required by 21 CFR 111.65, to implement quality control operations for the manufacturing, packing, labeling and holding operations for producing dietary supplements.
You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with the dietary supplements, as required by 21 CFR 111.70(d). Specifically, your firm reviews and approves the labeling for your finish supplement products. However, your firm does not have any labeling procedures that outline the dimensions, text requirements, or any other labeling elements to ensure the label is adequate, contains all of the required information and is in the correct format.
You failed to establish specification for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of the 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, as required by 21CFR 11.70(e).
Once you have established the above specifications, you must determine whether the specifications have been met as required by 21CFR 111.73. We also note that you must make and keep records for established specifications, as required by 21CFR 111.95(b)(1).
3. You failed to make and keep written procedures to fulfill the requirements that apply to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you do not have any written procedures for reviewing and investigating product complaints, which, at a minimum, instruct quality control to review all product complaints to determine if the complaint involves a possible failure of a dietary supplement to meet its specifications, or whether the dietary supplement may result in a risk of illness or injury. During the inspection, we observed your Vice President handling at least one complaint over the phone, in which the consumer expressed concern of irregular bowel movements after taking your supplement. The incident was not documented and no action was taken by your firm.
4. You failed to make and keep records of written procedures for fulfilling requirements for returned dietary supplements, as required by 21CFR 111.535(b)(1) and 111.503. Specifically, you have not established written procedures for returned dietary supplements, which at a minimum, provide instructions on how to identify and quarantine dietary supplements until quality control personnel can conduct a material review and make a disposition decision.
5. You failed to collect and hold reserve samples of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you informed our investigators that you do not collect and hold reserve samples of any of the dietary supplement products you distribute. In addition, your President stated that your firm has not collected any reserve samples for any dietary supplements that were distributed from July 2013 to February 23, 2016.
6. You failed to make and keep written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1). Specifically, you do not have any documents pertaining to holding and distributing operations, such as records showing your dietary supplements were held under proper storage conditions and retaining reserve samples. In addition, you receive packaged and labeled dietary supplements from your contract manufacturers for distribution to customers, but you do not have any written procedures for your holding and distribution operations.
In addition, as a distributor that contracts with other manufacturers to manufacture, package, and/or label dietary supplements that your firm releases for distribution under your firm’s name and various brands, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the 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 that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, 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. 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 FD&C Act” can be held accountable for violations of the Act). In particular, the FD&C 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 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.
Your “Colon Relief” product label fails to include the part of the plant from which “Cascara Sagrada” and “Rhubarb” are derived.
Your “Woman Revived” product label fails to include the part of the plant from which “Black Cohosh,” and “Dong Quai” are derived.
Your “Ketone Cleanse” product label fails to include the part of the plant from which “African Mango,” “Cascara Sagrada,” “Ginger Goldenseal,” and “Rhubarb,” are derived.
Your “Colon Wipeout” product label fails to include the part of the plant from which “Cascara Sagrada,” “Ginger Goldenseal,” and “Cayenne Pepper” are derived.
Your “T Drive” product label fails to include the part of the plant from which “Tribulus Terrestris,” “Tongkat Ali” and Horny Goat Weed” are derived.
Your “Thyroid Support” product label fails to include the part of the plant from which “Schizandra,” Bladderwrack,” and “Cayenne Pepper” are derived.
Your “Yacon Syrup” product label fails to contain a “Supplement Facts” panel. While your product is labeled as a dietary supplement, it contains a “Nutrition Facts” panel.
Your “X Heat” product label fails to list your “Heat Blend,” “Muscle Blend” and “Energy Blend” in accordance with 21 CFR 101.36(c)(3).
Your “Natural Vine Multi Vitamin” product label fails to indicate the number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii)(B).
Your “White Mulberry” product label bears the claim “antioxidant rich formula.” However, your product does not meet the requirements for use of this claim as set forth in 21 CFR 101.54(b). In accordance with 21 CFR 101.54(b)(1), you may use the term “high” on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per RACC for a specific nutrient that is considered an antioxidant. The “White Mulberry” product label fails to list any nutrient that has an RDI or DRV per RACC. Therefore, the use of the phrase, “antioxidant rich formula” misbrands your product under 403(r)(1)(A) of the FD&C Act.
4. Your “Coconut Oil” product label (b)(4) appears to be misbranded with the meaning of section 403(q)(1)(A) of the FD&C Act [21 U.S.C. § 343(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) and 21 CFR 101.12(b) Table 2. The suggested use indicates 1-2 capsules daily, but the serving size lists 1 capsule. The serving size listed should be 2 capsules.
In addition, your “T Drive” product label indicates the ingredient “Tongkat Aki.” This is not a standardized common name as noted in Herbs of Commerce. The common or usual name of ingredients of dietary supplements that are botanicals shall be consistent with names standards in Herbs of Commerce. Your “Thyroid Support” product label indicates the level of copper per serving in “mcg” when the unit of measure should be “mg” as noted in 21 CFR 101.9(c)(8).
As a responsible official of a facility that manufactures/processes, packs, re-labels or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 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 and/or injunction.
Within fifteen (15) 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 being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Please submit your response to Paul E. Frazier, Compliance Officer, at the address of 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions please contact Mr. Frazier at (214) 253-5340.
 Desmethylsibutramine is a substance structurally similar to sibutramine.
 Thiosildenafil and sulfoaildenafil are synthetic chemical compounds that are structural analogs of sildenafil.

References: § 355
 § 342
 § 343
 § 321
 §321
 § 353
 § 352
 § 201
 § 352
 § 321
 § 352
 § 352
 § 331
 § 342
 v. 
 v. 
 § 343