Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Inspections, Compliance, Enforcement, and Criminal Investigations
CMS # 451629
VIA UPS OVERNIGHT
Tenzing Kunga, Owner
Tibetan Herbal Balance, Inc.
6 Pleasant St.
Malden, MA 02148-5167
Dear Mr. Kunga:
From December 18, 2014, to January 12, 2015, the U.S. Food and Drug Administration (FDA) inspected your facility located at 6 Pleasant St., Malden, MA 02148. Based on our inspection and subsequent review of your firm's website, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
Unapproved New Drug Violations
We reviewed your website at the internet address http://www.tibetanherbs.com in December 2015 and have determined that you take orders there for the products Liver Assist, Lung Support, and Respibalance. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of 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.
Your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of Liver Assist, Lung Support, and Respibalance for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
“Wanted to let you know that I recently started taking your Liver Assist. My doctor had said he thought I may have been exposed to hepatitis and that my liver proteins were totally out of whack. I took the Liver Assist for 2 months and had my test re-run and my liver function was 100% normal. Thank you for a great product”
“My son with COPD was greatly improved with your Lung Support, no longer on OXYGEN. Thank you.”
“I just wanted to tell you that your product is great! I ordered the Respibalance and I have not needed my inhalers now for the past month. I am able to sleep great and no longer wheeze all night!”
“I had to tell you this. I suggested your Asthma pills for my 10 year old nephew who had been having horrible asthma attacks. My sister tried many things, but there were side effects and nothing worked well. I found this online and told her to try it, and that was about a year ago. Since he finished that bottle, he hasn't had an asthma attack! THANK YOU!!!”
Your Liver Assist, Lung Support, and Respibalance products are not generally recognized as safe and effective for the above referenced uses and, therefore, each product is a “new drug” 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 the 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 submitted by a drug sponsor to demonstrate 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 Liver Assist, Lung Support, and Respibalance products 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, Liver Assist, Lung Support, and Respibalance 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)].
Dietary Supplement CGMP Violations
Even if your Liver Assist, Lung Support, and Respibalance products were not unapproved drugs, these products would be adulterated dietary supplements based on the violations listed below. In addition, your Acidity Support, Bladder Support, Blood Balance Support, Colon Support, Digestion Assist, Energy Tonic, Gastrointestinal Health Support, Happiness Support, Immune System Support, Joint Support 1, Joint Support 2, Kidney Support, Longevity Support, Mind Calm Support, Nerve Support 1, Nerve Support 2, Skin Clear Support, Sleep Assist products are also adulterated dietary supplements. During the inspection, our investigator observed your operations to consist of packaging privately-labeled finished dietary supplements from bulk dietary supplements supplied from independent vendors. Further, our investigator was informed that your firm is ultimately responsible for marketing and distributing your finished dietary supplement products. Significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111) were observed during this inspection. These violations cause the dietary supplements manufactured at your facility to be adulterated within the meaning of Section 402(g)(1) the Act [21 U.S.C. §342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
As a distributor that contracts with other manufacturers to manufacture 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, dietary supplements into interstate commerce in their 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 those products are in compliance with dietary supplement CGMP requirements found under 21 CFR Part 111.
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 supplements 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, delivering for introduction, or causing the delivery or introduction into interstate commerce of 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.
As a distributor, you have 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. Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution. See 21 CFR 111.127.
Our investigators’ observations were noted on form FDA-483, Inspectional Observations, which was issued to you on January 12, 2015. We also received your correspondence, dated January 21, 2015. The deviations below reflect our response to the observations in the FDA 483, as well as your firm’s correspondence.
1. You failed to establish specifications to sufficiently assure that the product you received for packaging or labeling as a dietary supplement is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
Specifically, during the inspection you provided a document titled “Specifications for Dietary Supplements Received”; however, this document is not comprised of specifications because it does not contain any information specifying the identity of any of the dietary supplement products that you receive and then subsequently package, label, and distribute.
We reviewed your response dated January 21, 2015. You state that you now require your bulk dietary supplement supplier to send additional documents, including a list of ingredients with each shipment; however we have found this response to be inadequate because it contains no information to demonstrate that you have set specifications to properly identify each of the products you are receiving from your supplier prior to packaging and labeling and ensure consistency with your purchase order.
Once you have established specifications to properly identify bulk dietary supplements to ensure consistency with your purchase order, you must visually examine the product and have documentation to determine whether the specifications established are met, as required by 21 CFR 111.75(e).
2. You did not maintain records of any material review and disposition decision on a returned dietary supplement, as required by 21 CFR 111.535(b)(2). Specifically, during the inspection you explained that approximately 359 bottles of finished dietary supplements were returned from your fulfillment center on or about November 5, 2014, for relabeling. You informed our investigator that the tablets from the returned products were co-mingled with the corresponding bulk dietary supplement stocks before being repackaged and shipped back to your fulfillment site on December 3, 2014, for customer distribution. Under 21 CFR 111.520 you may salvage a returned dietary supplement only if quality control personnel conduct a material review and make a disposition decision to allow the salvage. You did not maintain any records to demonstrate that quality control personnel had conducted a material review and disposition to allow the salvage of your returned dietary supplements.
Additionally, your firm failed to make or keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, you did not establish written procedures for the responsibilities of your quality control operations to conduct a material review and make a disposition decision for returned dietary supplements. We acknowledge that in your response, dated January 21, 2015, you stated that you will establish written procedures to conduct material reviews and dispositions. We cannot evaluate the adequacy of your response because you failed to provide documentation of your proposed written procedures.
3. Your Master Manufacturing Record did not include a representative label, or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).
Specifically, during the inspection, our investigator reviewed master manufacturing records for all of your products and noted they did not include a label or cross reference to the physical location of the actual or representative label.
We acknowledge that in your response, dated January 21, 2015, you stated that a representative label will be included in all master manufacturing records. However, we cannot evaluate the adequacy of your response because you failed to provide documentation of the revised master manufacturing records which include representative labels.
Further, we note that under 21 CFR 111.210(h)(3) your Master Manufacturing Records must include specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
We also note:
During the inspection, we observed that your hand-washing facilities were not convenient, as required by 21 CFR 111.15(i). Specifically, your facilities lacked hand-washing facilities in the production area where packaging and labeling of dietary supplements occurs.
In your response, dated January 21, 2015, you stated that you planned to move to a new production facility in April 2015 with adequate hand-washing facilities. To date, FDA has not received any additional correspondence regarding whether this move was completed or any information regarding the potential new location’s hand-washing facilities. In order to comply with 21 CFR 111.15(i), any facility at which you conduct operations must have adequate and convenient hand-washing facilities.
This letter is not intended as an all-inclusive list of the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations. You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, 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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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). 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your reply should be sent to the following address:
U.S. Food and Drug Administration
One Montvale Ave
Stoneham, MA 02180
If you have questions regarding this letter, please contact Rory K. Geyer, Compliance Officer at 781-587-7521 or email@example.com.
Joseph Matrisciano Jr.
Acting New England District Director