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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Advanced Nutritional Technology Inc. 10/16/12

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor bay Parkway 
Alameda, CA 94502
Telephone:    510-337-6700
FAX:    510-337-6703 

 

                                                                                                           
Via UPS        
 
October 16, 2012                                          
 
Grace S. Chang, Vice President
Advanced Nutritional Technology Inc.
6988 Sierra Court
Dublin, CA 94568-2641
 
                                                                                               
Dear Ms. Chang:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 6988 Sierra Court, Dublin, CA 94568, from April 25, 2012 through May 14, 2012. The inspection found that your facility has serious violations of the 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 identified below 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. 
 
In addition, we have reviewed the labeling for your products and your website at www.advancednutritionaltech.com. 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)] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Dietary Supplement CGMP Violations
 
1)    You failed to package and label in a way that ensures that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.415. Specifically, during the inspection, the FDA investigator observed 308 bottles of Super EPA 2000, Control No. 120109, Expiration Date: 01/2015, which your firm had packaged and labeled. You were unable to provide a master manufacturing record for the packaging and labeling of this product. A master manufacturing record for a firm that only packages and labels the dietary supplement must include specifications that are applicable to its operations. [See 72 Fed. Reg. 34752, 34902 (June 25, 2007)].    
 
You stated during the inspection that your firm would cease packaging and labeling retail-sized products. However, FDA is aware that retail purchases can still be made of the repackaged product.  
 
2)    You did not 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you stated that your firm does not have or follow written procedures for quality control operations. In addition, you could not provide records or documentation showing that your firm performs any quality control operations.
 
3)    You did not prepare a batch production record every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255 and 111.260. Specifically, during the inspection, the FDA investigator observed 308 bottles of Super EPA 2000, Control No. 120109, Expiration Date: 01/2015, which your firm had packaged and labeled. You were unable to provide a batch production record for this product, and you stated that such a record had not been made.  
 
As is discussed above, you stated that your firm would cease packaging and labeling retail-sized products; however, it appears that you have not ceased such operations.
 
4)    You did not establish and follow written procedures for fulfilling the requirements relating to the packaging and labels you receive, as required by 21 CFR 111.153, nor did you make and keep the records required by 21 CFR 111.180(b). Specifically, you stated that you did not have any written procedures to meet the requirements (set forth in 21 CFR 111.160) that apply to the packaging and labels you received and used in the packaging and labeling of your Super EPA 2000 product. Furthermore, you were unable to produce records showing that those requirements had been met. Although you stated that you visually check the shipment against the purchase order to ensure consistency, you could not provide any records to verify this activity.   
 
As is discussed above, you stated that your firm would cease packaging and labeling retail-sized products; however, it appears that you have not ceased such operations. 
 
5)    You did not establish and follow written procedures for your dietary supplement holding and distributing operations, as required by 21 CFR 111.453, nor did you hold dietary supplements under conditions that do not lead to the mixup of the supplements, as required by 21 CFR 111.455(c). Specifically, during the inspection, the FDA investigator observed dietary supplement product held in paper cartons that were hand-marked with the letter “A”; when asked to identify the product, your office manager, who was in charge of the operation that day in your absence, stated that she was uncertain, and that the letter “A” probably stands for Vitamin A. In addition, you had no written procedures for holding and distribution of your products and stated that you did not make or keep written procedures for this operation.
 
We note that you stated at the conclusion of the inspection that you would develop procedures for holding and distributing operations within three months. We will verify this correction at our next inspection.
 
6)    You did not establish and follow written procedures to fulfill the requirements (set forth in 21 CFR 111.560) that apply to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you stated that you do not have written complaint handling procedures.
 
We note that you stated at the conclusion of the inspection that you would develop complaint handling procedures within three months. We will verify this correction at our next inspection.
 
7)    You did not establish and follow written procedures to fulfill the requirements (set forth in 21 CFR subpart N) for the handling of returned dietary supplements, as required by 21 CFR 111.503. Specifically, you stated that you do not have written procedures for handling returned products.
 
We note that you stated at the conclusion of the inspection that you would develop procedures to handle returned dietary supplements within three months. We will verify this correction at our next inspection.
 
8)    You have not established and followed written procedures for fulfilling the requirements relating to the prevention of microbial contamination (as set forth in 21 CFR 111.10(a)) or for fulfilling the requirements relating to hygienic practices (as set forth in 21 CFR 111.10(b)), as required by 21 CFR 111.8. Specifically, the FDA investigator observed an employee packaging and labeling Super EPA 2000 product, which involved hand-manipulation of exposed product; however, you do not have procedures in place to fulfill the requirements relating to preventing microbial contamination from sick or infected personnel or relating to hygienic practices.
 
As is discussed above, you stated that your firm would cease packaging and labeling retail-sized products; however, it appears that you have not ceased such operations.
 
Misbranding of Dietary Supplements:
 
Your Co Enzyme Q10 product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the label fails to identify the product using the term ‘dietary supplement,’ or other appropriately descriptive term, in accordance with 21 CFR 101.3(g).
 
Your Co Enzyme Q10 product is also misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the label fails to bear nutrition information in the form of a Supplement Facts panel in accordance with 21 CFR 101.36.
 
Your Co Enzyme Q10 product is also misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that it fails to include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event related to your product.
 
Unapproved New Drugs:
 
Your product labels and website, www.advancednutritionaltech.com, were reviewed in July 2012 and we have determined that your products, Ultra Diabless, Nutr-E-Sol, Formula 3/6/9, Nutr-Epo, Super EPA 2000, Super G, Coenzyme Q10, and Crangel are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act.
 
Examples of the claims found on your product labels and website include:
 
Ultra Diabless webpage
  • “ULTRA DIABLESS is a blood sugar control formula …”
  • “[B]itter melon [an ingredient in your product ] may reduce blood sugar to low levels …”
  • “[B]itter melon [an ingredient in your product]… can improve glucose tolerance without increasing blood insulin levels, and to improve fasting blood glucose levels”
  • “The secret of green tea [an ingredient in your product]… has been effective in lowering LDL cholesterol levels …”
Nutr-E-Sol webpapge
  • “this product is useful in … diseases such as Cystic Fibrosis, Crohn's Disease, Short Bowel Syndrome, Biliary Cirrhosis …”
Formula 3/6/9 webpage
  • “EFA's [essential fatty acids – an ingredient in your product] are recommended in lowering cholesterol and blood pressure and reducing the risk of heart disease and stroke.”
Nutr-Epo webpage
  • “[E]vening primrose seed oil [an ingredient in your product]… is effective in … reducing symptoms of arthritis, allergies, skin disorders such as eczema, inflammatory problems, cardiovascular disease … ”
Super EPA 2000 webpage
  • “Taken for its cardiovascular benefits [EPA 2000] … dramatically reduce the risk of death, subsequent heart attacks, and stroke.”
  • “Also tend to have increased HDL cholesterol and decreased triglycerides …”
  • “Super EPA 2000 … have been shown to reduce LDL (“bad”) cholesterol and triglycerides.”
Super G webpage
  • “Decrease inflammation (i.e. due to asthma).”
  • “Help reduce the symptoms of arthritis, allergies, and eczema”
Coenzyme Q10 webpage
  • “[I]mprove ... heart function and circulation for those with congestive heart failure, ,,, high blood pressure, … and chest pain (angina).”
  • “[P]rotect against … heart attacks, chronic fatigue ... aging and cancer ...”
  • “[H]elp slow Alzheimer's or Parkinson's disease.”
Crangel webpage
  • “Cranberry extract [an ingredient in your product] has been demonstrated to aid in the treatment of cystitis and urinary tract infections.”
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)].   A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 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. 
 
Further, your products are 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 these products safely for their intended uses. Thus, the labeling fails to bear adequate directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not intended to be an all-inclusive list of violations at your facility and with your products, labels, and labeling. It is your responsibility to ensure that your products are in compliance with all applicable statutes and regulations, including the Act, the CGMP regulations for dietary supplements, and FDA’s food labeling regulations. 
 
You should take prompt action to correct the violations described in this letter. Failure to take appropriate corrective action may result in FDA taking regulatory action without further notice, such as injunction or seizure.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter and to prevent their recurrence. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections.
 
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 written response should be sent to Lawton W. Lum, Director of Compliance at the address noted above. If you have any questions concerning this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.
 
Sincerely,
/S/
Barbara Cassens
District Director
San Francisco District