Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm351946.htm
Timestamp: 2019-04-24 00:32:05+00:00

Document:
This letter is in response to the U.S. Food and Drug Administration (FDA) investigation of your firm Natures Health Options, LLC located at 6200 NW 2nd Ave, Unit 311, Boca Raton, Florida. FDA conducted its investigation from July 23, 2012 to July 25, 2012, at the FDA Boca Raton Resident Post.
During the investigation, you informed our investigator that your firm distributes Charantea Bitter Melon Ampalaya in 500 mg capsules and as tea bags; these products are labeled as dietary supplements. In addition, you informed our investigator that your firm has entered into agreements with contract manufacturers to manufacture these products and that your firm conducts holding and distribution operations for these products.
Based on our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.
You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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.
Further, your product is 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 products safely for their intended uses. Thus, the labeling fails to bear adequate directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
In addition, even if your product is not an unapproved new and misbranded drug, the Charantea Bitter Melon Ampalaya products packaged in 500 mg capsules would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, under Title 21, Code of Federal Regulations (CFR), Part 111 [21 CFR Part 111].
We received your written response, dated July 31, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Observations, that was issued to you on July 25, 2012. We address your response after the applicable violation, noted below.
1. Your firm failed to make and keep written procedures for the responsibility of 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)(1). .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 the approval and release of your dietary supplements by the quality control personnel.
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 manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form 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 Federal Food, Drug, and Cosmetic Act (FD&C 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 FD&C 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 FD&C 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.
You must establish a system of production and process controls 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). You must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must 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 (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)). However, you provided no documentation of the quality control review to ensure the quality of the dietary supplements you distribute and that they are packaged and labeled according to the master manufacturing record.
We have reviewed your response dated July 31, 2012 and determined it to be inadequate in that you did not provide documentation of written procedures for the quality control operations and the implementation of these procedures. Additionally, we note that you stated you will meet with your contract manufacturers to ensure that written procedures for quality control are in place; while your quality control procedure may include ensuring your contract manufacturers establish written procedures for quality control, the regulation requires your firm to establish your own quality control procedures to ensure the quality of your product that you hold and distribute. Therefore, to be compliant with the regulation, your written quality control procedures must address your holding and distribution operations, including the approval and release of your dietary supplements into interstate commerce, in addition to the items you affirm you will correct in your letter.
2. Your firm failed to make and keep written procedures for product complaints, as required by 21 CFR 111.570(b)(1). Specifically, your firm did not have written procedures for the handling of product complaints regarding the dietary supplement products you distribute and for adequately investigating complaints and documenting the findings of an investigation and follow-up.
We have reviewed your response dated July 31, 2012 and determined it to be inadequate because you failed to outline the specific steps you will take to address this deviation.
3. Your firm failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, you did not have written procedures for handling any returned dietary supplements, including procedures for handling returned dietary supplement that must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515, and for returned dietary supplement that may be salvaged in accordance with 21 CFR 111.520.
4. Your firm failed to establish written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1). Specifically, you indicated to our investigator that you pick up fully labeled, packaged, and ready for shipment finished product and then you subsequently ship to your customers. Therefore, your firm holds and distributes dietary supplement products and you must have written procedures for these manufacturing operations.
We have reviewed your response dated July 31, 2012, and have determined it to be inadequate. You state in your letter that you will ensure that your contract manufacturers for Tea and Vegetarian Caps establish and maintain written procedures for holding and distribution. Although your contract manufacturers must maintain written procedures for holding and distributing, your firm must maintain written procedures for holding and distributing dietary supplement product. In addition, you did not include a defined date when you will have these procedures in place.
The violations mentioned above are not intended to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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 noncompliance 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)). 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Section 201(ff)(2) of the Act [21 U.S.C. § 321(ff)] states, in part, that the term “dietary supplement” means a product that “is not represented for use as a conventional food.” A product that is labeled as a dietary supplement, cannot also be represented for use as a conventional food. If a product is labeled as a dietary supplement but does not meet the definition of a dietary supplement, e.g., because it is represented for use as a conventional food, the product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1) in that the description of the product as a dietary supplement is false and misleading. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act. [21 U.S.C. § 331(a)]. Therefore, if you want to market your Charantea Ampalaya Tea as a dietary supplement, the product cannot be represented for use as a conventional food (nor, as stated earlier, promoted for conditions that cause it to be a drug) and, among other requirements, must meet dietary supplement CGMP requirements in 21 CFR Part 111.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance officer at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.

References: § 321
 § 355
 § 352
 § 331
 § 342
 v. 
 v. 
 § 379
 § 379
 § 321
 § 343
 § 331