Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm430797.htm
Timestamp: 2019-04-26 03:49:12+00:00

Document:
The U.S. Food & Drug Administration (FDA) conducted an inspection of your facility, located at 3030 Campbellton Road SW, Suite A, Atlanta, Georgia, on August 18, through September 3, 2014. Our inspection determined that your firm distributes and is involved in the labeling of “The Aloe Man” and “Dr. Johnson’s” brand products, which are manufactured and labeled as dietary supplements for your firm and which your firm distributes under your firm’s name. During the inspection, our investigator collected labeling samples, including a brochure, which your firm sends out to customers with all outgoing orders. We also reviewed labeling on your firm’s website at www.aloeman.com in November 2014.
The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
We have reviewed the product brochure labeling for your The Aloe Man’s Super Bright, Dr. Johnson’s Maximum Desire, Dr. Johnson’s Body Healer, and Dr. Johnson’s Formula C products, as well as your website at the internet address www.aloeman.com in November 2014, where we have determined that you take orders for your The Aloe Man’s Super Bright and Dr. Johnson’s Body Healer products. The product labeling for these products, including your brochure and website, promotes the products for conditions that cause the products to be drugs as defined in section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)]. The therapeutic claims 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 for introduction into interstate commerce for such uses violates the Act.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, they are “new drugs” as defined by 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331 (d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Dr. Johnson’s Maximum Desire and Dr. Johnson’s Body Healer 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 products is 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)].
Even if the products listed above did not have claims which make them drugs, they are nevertheless adulterated dietary supplements. During the inspection of your facility, our investigator observed serious violations of the Current Good Manufacturing Practice (cGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your proprietary dietary supplement products to 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 cGMP regulations for dietary supplements in 21 CFR Part 111. Our investigator’s observations were noted on Form FDA-483 entitled “Inspectional Observations,” which was issued to you at the close of the inspection.
We acknowledge receipt of your FDA-483 response dated September 26, 2014. We intend to verify the adequacy of any corrective actions at a future 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 21 CFR 111.140(b). Your firm’s quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). You provided no written procedures for, or documentation of, the approval for release of your dietary supplements by quality control personnel.
We note that, to the extent you receive products from a supplier for packaging or labeling, as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide for sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Moreover, to the extent you contract 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 manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)].
During the inspection, you stated that your firm distributes proprietary dietary supplement products under “The Aloe Man” and “Dr. Johnson’s” brand names and that these dietary supplement products are manufactured for your firm by (b)(4) and (b)(4). Although a 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. 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)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the 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 (21 CFR 111.105).
Whether you receive product from a supplier or from a contract manufacturer, you must have documentation of the quality control personnel review and approval for release of any packaged or labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)). In addition, you must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). As noted above, you provided no documentation to meet these requirements.
In your response letter, dated September 26, 2014, you stated, “[W]e have since brought on a person who will handle Quality Control Operations. He is scheduled for training on November 4th and 5th, 2014.” However, we cannot assess the adequacy of your response because you did not provide us with a timeline when the quality control procedures will be established and followed, nor did you provide evidence that written procedures for quality control operations have been established and followed. We intend to verify the adequacy of your corrective action and other corrective actions at a future inspection.
2. Your firm failed to establish and follow written procedures for product complaints, as required by 21 CFR 111.553. During the inspection, you stated that your firm has not established and does not follow written procedures for the handling of product complaints regarding the dietary supplement products you distribute. You also stated that you do not document product complaints received by your firm. We note that you must maintain a written record of every product complaint that is related to good manufacturing practice (21 CFR 111.570(b)(2)).
We are unable to assess the adequacy of your September 26, 2014, response. Your response states that you have implemented procedures to fulfill the requirements that apply to the review and investigation of product complaints; however, you did not include any copies of your written procedures or documentation demonstrating that these procedures are being followed. We intend to verify the adequacy of your corrective action at a future inspection.
3. You failed to establish and follow written procedures for holding and distributing operations as required by 21 CFR 111.453. As noted during the inspection, your firm holds and distributes dietary supplements; however, your firm has not established or followed written procedures for holding and distributing dietary supplements.
In your September 26, 2014, response, you stated that you have now made written procedures for holding and distributing operations and that these procedures will be carried out by your firm. However, we are unable to assess the adequacy of your response because you did not include copies of the written procedures or supporting documentation to demonstrate that these procedures are being followed. We intend to verify the adequacy of your corrective action at a future inspection.
4. You also 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). During the inspection, you stated that your firm does not keep reserve samples of finished dietary supplement products that you distribute.
We find your September 26, 2014, response to be inadequate. Your response stated that samples were already being retained by the companies that manufacture your products; however, as a distributor of packaged and labeled dietary supplements, you are required to collect and hold reserve samples.
1. Your Dr. Johnson’s G.A.P. Pills product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)]. The serving size declared on the labels 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 directions suggest take two tablets three time daily; however, the serving size states for adults: 1 Tablet.
2. Your Dr. Johnson’s G.A.P. Pills product label is misbranded within the meaning of section 403(q)(1)(B) because the label fails to list the servings per container under the serving size on the left hand side of the nutrition label in accordance with 21 CFR 101.36(b)(1)(ii).
3. Your Dr. Johnson’s G.A.P. Pills product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
Your Dr. Johnson’s G.A.P. Pills product label fails to include the part of the plants from which Garlic (Allium sativum)and Aloe Vera (Aloe barbadensis) are derived.
Your The Aloe Man’s Immuno Force product label fails to include the part of the plant from which Lily of the Valley (Convallaria majalis) is derived.
Your Dr. Johnson’s Body Healer product label fails to include the part of the plants from which Tormentilla (Potentilla erecta) is derived.
This letter is not intended to be an all-inclusive list of the 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 that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to promptly correct these violations may result in FDA taking enforcement action without further notice, including, without limitation, seizure and 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 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.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990 or write her at the noted address.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331
 § 342
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 §343
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