Inspections, Compliance, Enforcement, and Criminal Investigations

YoungYou International Inc 10/7/14

  

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
 
October 7, 2014
WL#  1-15
Victoria V. Fleishman, President
YoungYou International, Inc.
18226 Ventura Blvd., Suite 101
Tarzana, CA 91356
 
Dear Ms. Fleishman:
 
From October 28 through October 31, 2013, the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 18226 Ventura Blvd., Suite 101, Tarzana, CA 91356. Based on our inspection and subsequent review of your product labeling collected during the inspection, as well as your firm’s websites at www.youngyoucorp.com and www.slimbionic.com, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
 
We acknowledge receipt of your response letters, dated November 21, 2013, and January 13, 2014, to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of the inspection on October 31, 2013, and we address your responses below.
 
Unapproved New Drugs and Misbranded New Drugs
 
We have reviewed the labeling of your products collected during the inspection, as well as your websites at www.youngyoucorp.com and www.slimbionic.com in March 2014, from which websites we have determined that you take orders for several of your products, including your Slimbyonicx Weight Loss Pills. Based on our review, we have determined that your website and other product labeling promote your Slimbyonicx Weight Loss Pills for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites and other product labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. 
 
The following is an example of a claim that provides evidence that your product is intended for use as a drug:
 
On the www.youngyoucorp.com and www.slimbionic.com webpages titled, “Slimbyonicx Weight Loss Pills”, under the “Description” section:
  • “LOWERS CHOLESTEROL”
Your Slimbyonicx Weight Loss Pills 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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce 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.
 
Furthermore, your Slimbyonicx Weight Loss Pills 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 the drug safely for its intended purposes. Thus, this product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Dietary Supplements
 
Our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CMGP) regulations for dietary supplements, found in Title 21 of the Code of Federal Regulations, 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 Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. In addition, even if your Slimbyonicx Weight Loss Pills product were not an unapproved new drug, the product would be an adulterated dietary supplement under section 402(g)(1) of the Act.
 
During the inspection, investigators observed the following significant violations:
 
1.    You failed to hold products received from your contract manufacturer for packaging and labeling as a dietary supplement under conditions that will protect against contamination and deterioration, and avoid mix-ups, as required by 21 CFR 111.165(e) and 21 CFR 111.455(c). Specifically, you receive dietary supplements from your contract manufacturer in white plastic, unlabeled bottles that do not contain the name of the product, lot code, or expiration date on the outside of the box containing these products, or any other information that would help differentiate the product from different lots or shipments.
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2013, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you stated you have created a standard operating procedure (SOP) to address this issue. Your response, however, did not include specific SOPs that you highlighted in your response letter as addressing this violation, and it did not include procedures for holding product received for packaging and labeling under conditions that will protect against contamination and deterioration, and avoid mix-ups.
 
2.    You failed to establish specifications to provide sufficient assurance that the product you receive from your supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, you failed to establish specifications for labeled and unlabeled packaged products that you receive from your supplier for packaging and labeling prior to distribution. Once you establish such specifications, you must review the results of any visual examination and documentation to ensure that specifications established under 21 CFR 111.70(f) are met, as required by 21 CFR 111.127(a). 
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2014, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you stated that you created SOP (b)(4) Product Specification procedure which describes how your firm creates product specifications; however, the procedures do not provide evidence of how labeled and unlabeled packaged products are received and inspected in accordance with established specifications.
 
3.    You failed to establish and keep written procedures and records for your labeling operations, as required by 21 CFR 111.403 and 21 CFR 111.430. Specifically, you failed to make and keep written procedures and records for your labeling operations.
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2014, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you provided copies of SOP (b)(4) Label Approval Process, SOP (b)(4) Labeling Reconciliation, and SOP (b)(4) Product Labeling and Release. However, your product labeling and release procedures do not address how you will assign batch, lot, or control numbers to each lot of labeled dietary supplement, and your firm’s response does not provide evidence on how you are implementing these new procedures for product labeling operations.
 
4.    You failed to establish and follow quality control operations for packaging and labeling, as required by 21 CFR 111.127. Specifically, you do not have quality control operations for approving, and releasing from quarantine, all products that you receive for labeling as a dietary supplement (and for distribution rather than for return to the supplier) before they are labeled [21 CFR 111.127(b)] and for approving for release, or rejecting, any labeled dietary supplement for distribution [21 CFR 111.127(h)]. 
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2014, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you stated that you created certain SOPs to address this violation. Your response, however, did not include specific SOPs that you highlighted in your response letter as addressing this violation, and your response is inadequate to address how your quality control operation will perform a documented review of any visual examination of dietary supplements at receiving, and how you will approve and release products from quarantine when they are received and before they are used for packaging and labeling.
 
5.    You failed to maintain documentation to permit you to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution, as required by 21 CFR 111.410(d). Specifically, you do not maintain complete records covering the receipt, labeling, and distribution of dietary supplements at your facility.
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2014, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you stated that you created SOP (b)(4) in response to this violation, but you did not provide SOP (b)(4) with your response. Your response did not include procedures for product identification and traceability for our review.
 
6.    You failed to retain reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not retain reserve samples of dietary supplements that you label and distribute from your facility. Furthermore, you failed to make and keep written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1). Specifically, you failed to establish written procedure to ensure that reserve samples are collected and maintained.
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2013, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you provided a copy of SOP (b)(4) Product Labeling and Release Procedure. However, the procedure does not detail the number of product samples retained specifically as reserve samples and did not provide evidence on how you are implementing these new procedures.
 
7.    You failed to establish written procedures for the requirements to review and investigate a product complaint, as required by 21 CFR 111.553. Specifically, you do not have written procedures which cover the requirements for obtaining, handling, and investigating (when needed) information obtained from product complaints related to dietary supplements distributed from your facility. Such procedures must include procedures for making and keeping a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2).
 
We have reviewed your response letters dated November 21, 2013, and January 13, 2014, and find them inadequate to address the violation. We acknowledge that in your response dated January 13, 2014, you stated that you created SOP (b)(4) Customer Complaint Procedure and SOP (b)(4) Adverse Event Procedure in response to this violation, but you did not provide either SOP with your response. Your response did not include the procedures for customer complaint and adverse event reporting for our review.
 
Misbranded Dietary Supplements
 
Your Megaslim Herbal Appetite Management and E-Z Weight Loss Pills products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling requirements under 21 CFR Part 101. In addition, even if your Slimbyonicx Weight Loss Pills product were not an unapproved new drug, it would be a misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343].
 
1.    Your Megaslim Herbal Appetite Management and Slimbyonicx Weight Loss Pills products are misbranded under section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the product labels fail to identify the products 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 products' statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
 
2.    Your Megaslim Herbal Appetite Management and E-Z Weight Loss Pills products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are contained in capsules, but the capsule ingredients are not listed on the labels [21 CFR 101.4(g)].
 
3.    Your Megaslim Herbal Appetite Management, E-Z Weight Loss Pills, and Slimbyonicx Weight Loss Pills products are misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)].
Specifically,
 
  • Your E-Z Weight Loss Pills product label does not declare serving size and servings per container as required by 21 CFR 101.36(b)(1).
  • Your Megaslim Herbal Appetite Management, E-Z Weight Loss Pills, and Slimbyonicx product labels are not in the appropriate format in accordance with 21 CFR 101.36(e).
 
This violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
In addition, we have the following labeling comments for your Megaslim Herbal Appetite Management and E-Z Weight Loss Pills products.
  • Your Megaslim Herbal Appetite Management and E-Z Weight Loss Pills product labels failed to include a symbol (e.g., asterisk) under the heading "% Daily Value," if present, or immediately following the quantitative amount by weight for the proprietary blend, which refers to the same symbol placed at the bottom of the nutrition label that is followed by the statement "Daily Value not established," in accordance with 21 CFR 101.36(b)(3)(c)(3).
  • The statement of identity for your E-Z Weight Loss Pills product is not presented on the product label's principle display panel as required by 21 CFR 101.3(a).
  
We acknowledge that you have voluntarily recalled your Megaslim Herbal Appetite Management product because it was found to contain DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, which is an unsafe food additive. Please provide this office with the status of your activities of this on-going recall and any action plan you have to prevent this from reoccurring.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 
 
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 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, FDA may assess fees to cover any reinspection-related costs.
 
Your reply should be sent to the following address:
 
Acting Director, Compliance Branch
U.S. Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
 
If you have questions regarding this letter, please contact Dr. Raymond W. Brullo, D.P.M., Compliance Officer, at 949.608.2918, or via e-mail to Raymond.Brullo@fda.hhs.gov. Include the Case ID # 3007322782 in all correspondence.
 
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District

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