Inspections, Compliance, Enforcement, and Criminal Investigations

Rx Vitamins, Inc 3/17/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

 

March 17, 2016
 
WARNING LETTER NYK-2016-28
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
 
Mr. Craig T. Kisciras, President & CEO
Rx Vitamins, Inc.
150 Clearbrook Rd., Suite 149
Elmsford, NY 10523
 
 
Dear Mr. Kisciras:
 
On September 21, 2015 through September 28, 2015, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 150 Clearbrook Rd., Suite 149, Elmsford, New York. You indicated that you own all the formulas and labels of the dietary supplements that your firm distributes. Based on the inspection and a review of your product labels for Acid Block, Activated Enzyme Formula, ARTH-9, Chewable Licorice, NaturLo Cholesterol, ResveraCaps, Advanced Prostate Formula, DB-7 Capsules, Testost-Rx Formula Capsules, ThyRx-7, The Ocular Formula, and The Bone Density Formula, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the FD&C Act and the Code of Federal Regulations (CFR) through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drugs
 
During the inspection of your facility, we collected labeling for your products, including product labels and a catalog that your firm provides to customers along with their orders. 
 
Further, this is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.rxvitamins.com in January of 2016 and has determined that you take orders for the products Acid Block, Activated Enzyme Formula, ARTH-9, Chewable Licorice, NaturLo Cholesterol, and Advanced Prostate Formula]. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]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. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. 
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Acid Block
  • “[A]lginic acid and sodium alginate react with saliva and gastric acid to form a foamy froth or alginic raft that floats on top of the gastric contents and acts as a barrier to acid…reflux. Slippery elm and deglycyrrhized licorice act as demulcents which are soothing to the alimentary canal. . .”
  • “[R]eflux with Heartburn”
Activated Enzyme Formula
  • “[I]ncludes Aminogen®, a natural proteolytic enzyme complex, along with amylase and lipase which address enzyme deficiency. . .”
ARTH-9
  • "[F]ortified with Vitamin C, calcium and zinc l-monomethionine to aid in tissue repair…”
Chewable Licorice
  • “[C]linical studies have demonstrated its benefits in the treatment of gastric ulcers…”
NaturLo Cholesterol
  • “[S]hown in clinical studies to significantly lower LDL cholesterol…”
Advanced Prostate Formula
  • “[P]rostate gland tends to enlarge naturally, impeding bladder function…Advanced Prostate Formula…designed to address this concern…”
Your Acid Block, Activated Enzyme Formula, ARTH-9, Chewable Licorice, , NaturLo Cholesterol, and Advanced Prostate Formula products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under 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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products Chewable Licorice, NaturLo Cholesterol, and Advanced Prostate Formula are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Chewable Licorice, NaturLo Cholesterol, and Advanced Prostate Formula fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
  
Misbranded Dietary Supplements
 
1.    Your “Testost-Rx,” “DB-7,” “The Bone Density Formula,” “NaturLo Cholesterol,” “ThyRx-7,” and “Arth-9” product’s labels are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include complete addresses or phone numbers.
 
2.    Your “ThyRx-7” and “Arth-9” products are misbranded within the meaning of section 403(q)(1)(A) of the 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. Specifically,
 
      • Your ThyRx-7 product states to consume “1 capsule twice daily,” but the serving size lists “2 Capsules.” The serving size should be 1 Capsule. 
      • Your Arth-9 product states to “take two capsules twice daily,” but the serving size lists “4 Capsules.” The serving size should be 2 Capsules.
 
3.     Your “ThyRx-7,” “The Ocular Formula” and “The Bone Density Formula” products are misbranded within the meaning of 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 labels do not comply with 21 CFR 101.36. Specifically,
      • Your “ThyRx-7” and “The Ocular Formula” product labels list Selenium in the wrong order. Selenium, its quantitative amount by weight per serving, and percent of the daily value should be listed before Copper in accordance with 21 CFR 101.36(b)(2)(i)(B).
      • Your “The Bone Density Formula” product label lists Vitamins C and D in the wrong order. Vitamins C and D, their quantitative amounts by weight per serving, and percent of the daily value should be listed before Calcium in accordance with 21 CFR 101.36(b)(2)(i)(B).
      • Your “Arth-9” product labels list Zinc in the wrong order. Zinc, its quantitative amount by weight per serving, and percent of the daily value should be listed before Copper in accordance with 21 CFR 101.36(b)(2)(i)(B).
 
4.     Your “ThyRx-7” product is misbranded within the meaning of sections 403(q)(5)(F) and 403(s)(2)(A) of the FD&C Act [21 U.S.C. §§ 343(q)(5)(F) and 343(s)(2)(A)] in that the supplement facts label fails to list the name and quantity of each dietary ingredient that is described in section 201(ff) in the appropriate section of the Supplement Facts panel. For example, the ingredient pantethine, which is a derivative of pantothenic acid but not a vitamin, is incorrectly listed with (b)(2)-dietary ingredients. Since a reference daily intake (RDI) or a Daily Reference Value (DRV) has not been established for pantethine, it cannot be declared as a (b)(2)-dietary ingredient. A (b)(2)-dietary ingredient is one for which an RDI or DRV has been established. The listing of pantethine is not in accordance with 21 CFR 101.36(b)(3).
 
5.     Your “Testost-Rx,” “DB-7,” “ThyRx-7,” “Arth-9,” and “The Ocular Formula” products are misbranded within the 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).
 
6.     Your “Testost-Rx,” “DB-7,” “ThyRx-7,” and “Arth-9” products are misbranded within the meaning of section 403(s)(2)(C) because the labels fail to identify the part of the plant (e.g., seed, leaves) from which the ingredients are derived in accordance with 21 CFR 101.4(h)(1). For example,
 
  • Your “Testost-Rx” product label fails to include the part of the plant from which Yohimbe is derived.
  • Your “DB-7” product label fails to include the part of the plant from which Gymnema sylvestre is derived.
  • Your “ThyRx-7” product label fails to include the part of the plant from which Bladderwrack and Ashwaganda are derived.
  • Your “Arth-9” product label fails to include the part of the plant from which Boswellia serrata and Curcuma longa are derived.
  • Your “The Ocular Formula” product label fails to include the part of the plant from which Bilberry and Dunaliella salina are derived.
This letter is not an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 products comply with the FD&C Act and FDA’s implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations specified above may result in legal action without further notice, including, without limitation, seizure or injunction.  
 
Comment:
 
We note that during the inspection, our investigators were informed that your firm has entered into agreements with contract manufacturers to manufacture your dietary supplement products. 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 (1983) (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), 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 dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
You must implement 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, as required by 21 CFR 111.55. You must establish and follow written procedures for the responsibilities of the quality control operations, as required by 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, as required by 21 CFR 111.105. Furthermore, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement, as required by 21 CFR 111.127(h) and 111.140(b)(2).  
 
Section 743 of the FD&C 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 FD&C 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 noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
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 these violations and to prevent similar violations from occurring in the future. 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: LCDR Catherine Beer, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactLCDR Catherine Beerat 518-453-2314 x1015. 
 
Sincerely,
/S/ 
Ronald Pace                                                   
District Director
New York District

Page Last Updated: 03/24/2016
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