Inspections, Compliance, Enforcement, and Criminal Investigations

Beauty & Health International Inc. 2/5/16

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX:      949-608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
February 5, 2016        
                                                                                                                                                   
WL# 21-16
Dr. Charles G. Myung
President
Beauty & Health International, Inc.
7541 Anthony Avenue
Garden Grove, CA 92841-4005, US
 
Dear Dr. Myung,
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Beauty & Health International Inc., located at 7541 Anthony Avenue, Garden Grove, California on August 25, 2015 to August 28, 2015. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under 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 CGMP requirements for dietary supplements.  The investigator’s observations were noted on form FDA-483, Inspectional Observations, which was issued to you on August 28, 2015. 
 
Additionally, our investigator collected and reviewed labeling of your dietary supplements. Further, your products bear your internet website address “www.nutriwell.net” and we reviewed the labeling on your website at www.nutriwell.net in October of 2015. Based on our review, we have concluded that your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)].  You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
We received a written response from you dated September 23, 2015, concerning our investigator’s observations noted on the FDA 483 issued to you. We address each relevant response, in relation to each of the noted violations.
 
Unapproved New Drug
 
The FDA reviewed your products labels and your website at www.nutriwell.net in October of 2015, and has determined that you take orders there for your “Dr. Immune H-100,” “Nopal with Garlic,” “Tea Tree Oil,” “Shea Butter Oil,” “Ginseng Gro Oil,” “Eye Wrinkle Cream,” and “Quinol” products. The claims on your product labels and your website establish that the products are drugs under section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)] because they are intended for use in the cure, mitigation, treatment or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the label and website claims that provide evidence that your products are intended for use as drugs include: 
 
Dr. Immune H-100
  • On the product label: “Improve recovery from extreme stress and illness like burn, surgery, and cancer.”
Nopal with garlic
  • On the product label: “Nopal…several human studies show possible lowering of blood sugar levels”
Tea Tree Oil
  • “Essential oil with proven natural antiseptic against a wide range of bacteria and fungi.”
Shea Butter Oil
  • “Protects skin against …UV aggression.”
Ginseng Gro Oil
  • “Stimulate Root!”
  • “Helps to grow hair fast”
  • “Formula made from ginseng, dong quai, rosemary and horsetail, which have been known to help circulation and stimulate hair growth.”
Eye Wrinkle Cream
  • “Helps reduce swelling...”
Quinol
  • “Quinol is a face whitening cream that contains alpha hydroxy acid and a fading agent to help lighten skin... Helps lighten dark spots, liver spots…”
Your 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 marketed in the U.S. 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.
 
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 “Dr. Immune H-100” and “Nopal with garlic” 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, your “Dr. Immune H-100” and “Nopal with garlic” products 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 of or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Dietary Supplements
 
Even if your products did not have these therapeutic claims, which make them drugs, your products are adulterated within the meaning of 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 Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).  
 
Specifically, during our inspection, our investigators observed the following violations, which were noted on form FDA 483, Inspectional Observations, issued to you on August 28, 2015. As of September 23, 2015 you failed to provide a response to address the serious observations, which were presented to you during the inspection of your facility and you failed to provide any documentation that indicates you have begun an effective corrective action plan to bring your firm into compliance with 21 CFR Part 111. 
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
1.   You failed to establish the required specifications for 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, as required by 21 CFR 111.70(a). Specifically,
    • You failed to establish the following component specifications for each component that you use in the manufacture of a dietary supplement:
a)     Identity specifications [21 CFR 111.70(b)(1)];
b)     Component specifications that are necessary to ensure that specifications for the purity and strength of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]; and
c)     Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)];
    • You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).
    • 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 to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established component and product specifications, you must verify that the specifications are met in accordance with 21 CFR 111.75.
 
We have reviewed your response dated September 23, 2015, and we are unable to evaluate the adequacy of your response because you failed to provide evidence of having established component, in-process, or finished product specifications.
 
2.    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.
 
Specifically, you have not established written procedures for quality control operations for component receiving operations, packaging and labeling operations, laboratory operations, and holding and distributing operations.
 
Once you have established your written quality control procedures you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement 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 111.65.
 
We have reviewed your response dated September 23, 2015, and we are unable to evaluate the adequacy of your response because you failed to provide evidence of having established written procedures for quality control and operations.
 
3.    Further, you failed to include the following elements on your written master manufacturing records (MMRs) for your Colonite, Garlite, Nopal and Garlic, and Dr. Immune H-100 products as required by 21 CFR 111.210. Specifically,
 
a.    A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
 
b.    A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)];
 
c.    Written instructions, including the following:
  • Specifications for each point, step, or stage 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 [21 CFR 111.210(h)(1)];
  • Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2);
  • For your manual operations one person adding the component and another verifying the addition [21 CFR 111.210(h)(3)(ii)(B)];
  • Corrective action plan for use when a specification is not met [21 CFR 111.210(h)(5)] 
We acknowledge your response, dated September 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We find your response to be inadequate in that you failed to address the above mentioned requirements under 21 CFR 111.210.
 
Misbranded Dietary Supplements
 
1.    Your “Gar-lite” and “Nopal with garlic” 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 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. For example,
  • The directions of use on the “Gar-lite” product label suggest the consumer take one or two capsules with meals, but the serving size lists 1 capsule. The serving size listed should be two capsules.
  • The directions of use on the “Nopal with garlic” product label suggest the consumer take two capsules with a meal, but the serving size lists 1 capsule. The serving size listed should be two capsules.
2.    Your “Gar-lite,” “Colonite,” and “Nopal with garlic” products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C.  § 343(s)(2)(C)] )] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example,
  • Your “Gar-lite” and “Nopal with garlic” product labels fail to include the part of the plant from which garlic is derived.
  • Your “Colonite” product label fails to include the part of the plant from which senna is derived.
3.    Your “Nopal with Garlic” 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.
 
4.    Your “Colonite” product is misbranded within the meaning of section 403(q)(5)(f) of the Act [21 U.S.C. §343(q)(5)(f)] because the product label appears to include a proprietary blend, Fiber Blend Concentrate; however, the label does not list the individual ingredients of the blend as required by 21 CFR 101.36(c) and “senna” is not declared within the “Supplement Facts” panel as required by 21 CFR 101.36(b)(3).
 
This letter is not an intended to be an all-inclusive list of violations 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 establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. 
 
Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. 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.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the 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. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, the FDA may assess fees to cover any reinspection-related costs.
 
Your firm’s response should be sent to: 
 
CAPT Daniel Cline, Acting Director
Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506 
 
If you have any questions about the content of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477. Include Special Identifier FEI #3004377822 on all correspondence.
 
Sincerely,
/S/ 
LCDR Steven Porter, Acting Director
Los Angeles District
 
Cc:
Dr. Charles G. Myung, President
Beauty & Health International, Inc.
P.O. Box 890
Westminster, CA 92684
 
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413

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