Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
April 25, 2013
WARNING LETTER NYK-2012-17
Ms. Ruth Sobel
Quantum Herbal Products, Inc.
20 DeWitt Drive
Saugerties, NY 12477
Dear Ms. Sobel:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 20 DeWitt Drive, Saugerties New York on June 13 through June 28, 2012. During the inspection, our investigators found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (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 addition, your firm failed to submit a Serious Adverse Event Report for dietary supplements, as required under Section 761 of the Act [21 U.S.C. 379aa-1].
During the inspection of your facility, labeling for your products were also collected, including product labels and promotional brochures that your firm provides to customers. In addition, we reviewed your website at www.quantumherbalproducts.com. Based on our review, we have concluded that your Breath Freely Formula and Colloidal Silver, products are promoted 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 establish that this products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these product with these claims violates the Act.
FDA has also reviewed the labels for several of your products and has determined that these products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. 343] in that these labels fail to include required information.
You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the claims observed on the labels for your products, accompanying promotional literature, and your website include, but are not limited to, the following:
Breathe Freely Formula (1 Fluid Oz.)
- “[F]ound them to be as effective as corticosteroids without the accompanying toxicity.”
- “[W]as sufficient to eliminate or drastically reduce the use of an inhaler.”
Colloidal Silver (2 Fluid Oz.)
- “[P]otent non-toxic natural antibiotic.”
Your Breath Freely Formula and Colloidal Silver 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)]. Under section 301(d) and 505(a) of the 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. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Dietary Supplement CGMP Violations
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CPR 111.75(a)(1)(i), nor have you filed or been granted approval for exemption from this testing as described in 21 CFR 111.75(a)(1)(ii). For example, Slippery Elm Powder (Lot No. (b)(4)) was used in the manufacture of Bronchial Formula (Lot No. (b)(4)) without conducting an appropriate identity test or any other analysis.
We have reviewed your response, dated August 27, 2012, and found it to be inadequate. The example certificate of analysis that was submitted fails to contain an identity test, the specific testing methods for several of the conducted test and the acceptance criteria. Additionally, your response does not address the testing that will be done to confirm the COA when received.
2. Your firm did not establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(a). Specifically:
- You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure specifications are met, as required by 21 CFR 111.70(c).
- You failed to establish product specifications 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, as required by 21 CFR 111.70(e).
Your Quality Control Personnel must approve specifications, among other things, as required by 21 CFR 111.105(a). In addition, once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.75.
We have reviewed your responses, dated August 27, 2012 and October 15, 2012, and found them to be inadequate. Your responses address your firm's proposed corrective actions for products "(b)(4)". This approach indicates that your firm fails to understand that you must establish specifications for components/ingredients, in-process materials and finished products. You must then determine whether these specifications are met as prescribed in 21 CFR 111.75, which, among other things, provides flexibility in sampling plans [21 CFR 111.75(c)], reduced testing of specific ingredients in multiple ingredient formulas [21 CFR.75(c)(1)], and exemption of ingredients for which no analysis can be done [111.75(d)(1)]. The tests and examinations that you use must be appropriate and scientifically valid methods [21 CFR 111.75(h)]. Scientifically valid tests include official, validated methods as well as tests based on scientific data or results published in, for example, scientific journals, references, text books, or proprietary research [72 FR 34752 at 34854, June 25, 2007].
3. You failed to follow the requirements for product complaints under 21 CFR 111.553, 111.560 and 111.570. Specifically, your firm received (b)(4) complaints between 10/1/2010 and 6/13/2012; however, there is no documentation that a qualified person determined whether the product complaint involved a possible failure of a dietary supplement to meet any of its specifications, or other requirements and to further investigate any complaint that involves such a possible failure, as required by 21 CFR 111.560. Under 21 CFR 111.553, you are required to establish and follow written procedures to fulfill the requirements under 21 CFR Part 111 for product complaints (Subpart O). However, you did not follow the procedures specified under your complaint procedure "(b)(4)" effective date 7/11/2010. In addition, your records of these product complaints did not include the information required under 21 CFR 111.570.
We have reviewed your response, dated August 27, 2012, and found it to be inadequate. The sample document that you maintain as a record of a complaint still lacks information required under 21 CFR 111.570, such as the product lot information, if available, as well as the documentation that a review has been conducted. In addition, you did not submit your revised Complaint Reporting SOP for our review.
4. Your firm failed to establish and follow written procedures for the handling of returned dietary supplements, as required by 21 CFR 111.503. Specifically, you do not have any written procedures for handling returned dietary supplements.
We have reviewed your response, dated August 27, 2012, and found it to be inadequate. You state that the SOP for returned products has been revised; however you have not provided the revised SOP for our review.
5. You firm failed to make and keep records of written procedures for fulfilling requirements for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, your firm failed to establish written procedures to address the necessary steps to be followed when a distributed dietary supplement has been returned. Without established written procedures, your firm does not have a course of action to handle and document products returned, including a routine process pertaining to the receipt, quarantine, material review, salvaging and/or reprocessing, of the returned product.
Failure to Submit a Serious Adverse Event Report
Your firm failed to submit a Serious Adverse Event Report (SAER) for dietary supplements, as required under Section 761 of the Act [21 U.S.C. 379aa-1]. Your firm received a complaint for your supplement, ‘Breathe Freely’ on February 2, 2011 stating that “(b)(4) took Breathe Freely – made (b)(4) heart race.” No further information was documented, no investigation was conducted and your QC did not review the complaint report and the event was not reported to the FDA.
Under section 761(c) of the Act, you must submit a report of a serious adverse event associated with any of your dietary supplements no later 15 business days after a report of the event is received through the address or phone number provided on your dietary supplement products. Because prompt submission of such serious adverse event reports is important for public health reasons, the agency recommends that all serious adverse events be reported to FDA within 15 business days of receipt regardless of the means by which you receive the initial report. These serious adverse event reports must be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found on FDA’s website at www.fda.gov in the publication “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection.
Misbranded Dietary Supplements
Your Colloidal Silver product is misbranded under Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the product label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product.
Your Breath Freely Formula, Colloidal Silver, Female Energy Formula and Female Sexual Energy 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 labels fail to bear any nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36.
Your Breath Freely Formula, Female Energy Formula and Female Sexual Energy Formula products are misbranded within the meaning of 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the labels fail to identify the part of the plant (e .g., root, leaves) from which some of the dietary ingredients in the products are derived in English, as required by 21 CFR 101.4(h)(1).
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. 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: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
New York District
This page was posted on January 24, 2019.