Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm447204.htm
Timestamp: 2019-04-22 16:51:25+00:00

Document:
Investigators with the United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 2387 Midway Road, Carrollton, Texas, from February 26, 2014 through March 6, 2014. Based on our inspection and subsequent review of your product labeling collected during the inspection, as well as your firm’s website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations.
The FDA reviewed your websites, www.drdennisblack.com and www.texassuperfood.com, in August of 2014 and January of 2015, and has determined that you take orders there for the products “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Cleansing Combo Pak,” “Supersilver Solution,” “Royal Tea,” “Omega Oil 3•6•9,” “Probio Boost,” “CleanseMax,” “ParaMax Cleanse,” and “Heavy MetalMax” which the websites promote for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites establish that the products are drugs 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.
Furthermore, your “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Cleansing Combo Pak,” “Supersilver Solution,” “Royal Tea,” “Omega Oil 3•6•9,” “Probio Boost,” “ParaMax Cleanse,” and “Heavy MetalMax” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.
Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. It is also a violation of section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a drug that causes the drug to become misbranded while it is held for sale after the shipment of one or more of its components in interstate commerce.
Even if your “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules,” “Superfood Family Powder,” “Grab-N-Go Daily,” “Cleansing Combo Pak,” “Supersilver Solution,” “Royal Tea,” “Omega Oil 3•6•9,” “Probio Boost,” “CleanseMax,” “ParaMax Cleanse,” and “Heavy MetalMax” products did not have therapeutic claims which make them unapproved new drugs, these products and all dietary supplement products that you manufacture would still be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
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, 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 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)]. The Act also prohibits a person from doing any act with respect to a dietary supplement, if such act is done while the dietary supplement is held for sale after shipment in interstate commerce and results in the dietary supplement being adulterated [see 21 U.S.C § 331(k)]. 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. Further, you conduct final manufacturing in the form or packaging and labeling of your Grab-N-Go Daily and Royal Tea products which, in addition to the above, also obligates you for the development and documentation of records related to those manufacturing steps.
During our inspection, our investigators observed the following significant violations, which were noted on Form FDA 483, Inspectional Observations, issued to you on March 6, 2014. We received your written responses dated March 24, 2014, June 6, 2014, and July 7, 2014 to the Form FDA 483. Review of your responses and related documentation revealed that your firm has not made adequate corrections, as further described below.
1. You failed to establish specifications for identity, purity, strength, composition, and limits on contaminants for each component used in the manufacture of your dietary supplements, as required by 21 CFR 111.70(b). During the inspection you stated that you had no established specifications; in addition, you were unable to determine if your contract manufacturers had established specifications for your manufactured dietary supplement products.
Additionally, you were unable to provide records of established specifications for the ”Royal Tea” product that you receive from your contract manufacturer and further process into tea bags, and then package and label as required by 21 CFR 111.95(b)(1).
We have reviewed your response dated July 7, 2014 and find it to be inadequate. You have provided only a listing of the identity or name of the components for your products, which is not the same as a specification ensuring the identity, purity, strength or composition of the component.
2. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, during the inspection, you acknowledged that you have not developed specifications for any of your ten brand name dietary supplement products, or the components which are used to manufacture these products.
We have reviewed your response dated July 7, 2014. You have provided Certificates of Analysis (COAs) for various dietary ingredients, which you have obtained from your contract manufacturers and suppliers. However, in order to rely on a COA from the supplier of a component, you must first qualify the supplier by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s tests or examinations in accordance with 21 CFR 111.75(a)(2)(ii)(A). In your response, you stated that you have contacted each of your manufacturers and suppliers, and “have qualified each entity through a formalized protocol . . . .” Because you did not submit such a protocol or other documentation to demonstrate that you have qualified your suppliers, we are unable to evaluate the adequacy of your response.
3. You failed to establish specifications for the packaging and labeling of the finished dietary supplements, as required by 21 CFR 111.70(g). During the inspection you stated that you had no established specifications for the packaging and labeling of your finished dietary supplements.
Your written responses, dated March 24, 2014, June 6, 2014 and July 7, 2014, appear to reference the standard operating procedure manual which you provided in your March 24, 2014 response. However, this manual does not discuss packaging and labeling specifications. Further, the documents you provided and described as master manufacturing records (MMRs) for your “Grab-N-Go” and “Royal Tea” products do not reflect the manufacture of these products within your establishment.
You failed to prepare and follow a written 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 11.205(a). Specifically, at your facility, you perform the final packaging and labeling for the “Grab-N-Go” and “Royal Tea” products; however, you do not maintain any records related to these activities to ensure that the products are uniform from batch to batch. In addition, you failed to ensure that dietary supplements are packaged and labeled as specified in the MMR, as required by 21 CFR 111.205(b)(1).
We have reviewed your responses dated March 24, 2014, June 6, 2014, and July 7, 2014 and determined your response is inadequate. Although you have generated procedures for your packaging and labeling operations, these procedures are not MMRs.
4. You failed to establish a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of 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 111.55.
We have reviewed your responses dated March 24, 2014, June 6, 2014, and July 7, 2014. Your response states you have contacted each of your suppliers and have qualified them through a formal protocol, which includes evaluating the adequacy of the supplier’s COA. However, you did not provide this established protocol or data demonstrating you have verified the supplier’s COA. Further, your response states you have on-site staff reviewing the records provided by your suppliers that show their processes; however, your response does not include information to describe how you will document this review and approval. Because you have not provided any documentation, we are unable to evaluate the adequacy of your response.
5. You were not able to provide documentation which determined the complete manufacturing history and control of your packaged and labeled dietary supplement through distribution, as required by 21 CFR 111.410(d). Specifically, you do not assign a batch, lot, or control number to each lot of your “Grab-N-Go” and “Royal Tea” products that you label and/or package for distribution as required by 21 CFR 11.415(f)(1).
1. Your “Probio Boost,” “Omega Oil 3.6.9,” “Superfood Single,” ”Superfood Single Powder,” “Superfood Double Capsules,” “Superfood Family Capsules,” “Superfood Family Powder “Grab-N-Go,” “Supersilver Solution,” and “Royal Tea” products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
The nutrition information on your “Probio Boost” product label is not enclosed in a box, as required by 21 CFR 101.36(e)(2).
3. Your “Probio Boost,” “Omega Oil 3.6.9,” “Superfood Single,” “SuperFood Single Powder,” “Superfood Double Capsules,” “Superfoods Family Capsules, “Superfood Family Powder,” and “Royal Tea” products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1) because the labels do not contain the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
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 re-inspection 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.
Please submit your response to Jeff R. Wooley, Compliance Officer, at the above letterhead address. If you have any questions please contact Jeff R. Wooley, Compliance Officer, Dallas District Office at 214-253-5251.

References: § 321
 § 352
 § 331
 § 331
 § 342
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 § 331
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