Dietary Supplement CGMP Violations. Warning!
Consumers should be aware that dietary supplements are the least regulated. It’s great to see the FDA stepping up against this Florida company, siting “adulterated” products and “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 the drug is safe and effective.” BE Aware!
CERTIFIED MAIL & RETURN RECEIPT REQUESTED
WARNING LETTER. FLA-13-10. January 29, 2013
Patricia A. Riley, Owner/President, M.D.R. Fitness Corp.
14101 NW 4th St., Sunrise, FL 33325
Dear Ms. Riley:
From July 23rd through August 3, 2012, an investigator with the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 14101 NW 4th St., Sunrise, Florida. The inspection revealed you have failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111. These violations cause the dietary supplement products that you repack at your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21United States Code (U.S.C.) § 342(g)(1)] because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Our investigator’s observations were noted on the Form FDA 483, Inspectional Observations, issued to you on August 3, 2012.
In addition, FDA reviewed your internet website at www.mdr.com in October 2012 and has determined that your products Artery Factors, Cardio Tone, Cranberry Concentrate, Fitness Tabs for Men and Longevit-E are promoted for conditions which 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 on your website establish that your products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. The marketing of your products with these claims violates the Act.
You may find the Act and FDA regulations through links on FDA’s Internet home page atwww.fda.gov.
We acknowledge your written response dated August 14, 2012 to the Form FDA 483 Inspectional Observations, issued to your firm on August 3, 2012. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violation, noted below.
Unapproved New Drugs
Examples of some of the claims observed on your website include:
Artery Factors -“Artery Factors provides many well known cardioprotective ingredients such as:”
· “Grape Seed Extract and Natural Cocoa Powder: Rich in polyphenols…help lower high blood pressure, … and reduce oxidized LDL (bad cholesterol). Nutr Metab Cardiovasc Dis. 2011 May 5.”
· “Cinnamon Bark Extract: One of the biggest concerns of diabetes is damage to the vessels within the heart caused by high blood sugar levels. Cinnamon…has been used for centuries in Chinese medicine to help insulin signaling. J Med Food. 2011 Apr 11. In a recent study Cinnamon intake of about 1/4 teaspoon per day helped reduce blood pressure, fasting glucose… Journal of Human Hypertension (2010) 24, 568-576.”
· “L-arginine: … Since L-arginine may help arteries … it may also help with erectile dysfunction.”
Your web site also contains claims for Artery Factors in the form of personal testimonials under the heading Product Review including:
“I use other MDR products and have had great results for years but I have always needed high blood pressure meds. Within just a few days of taking this new Artery health formula [Artery Factors], I felt better and found my blood pressure stayed lower and in a normal range. Even my Doctor is amazed.”
· “Cranberries help control bacterial growth in the urine and prevent the bacteria from attaching itself to the lining of the urinary tract.(1,2)”
· “Recent research has found that cranberries may relieve lower urinary tract symptoms in older men, thereby improving prostate health…. Cranberries are now proven to be an inexpensive, natural and effective way to treat urinary tract symptoms … (4).”
Fitness Tabs for Men
· “Alpha Carotene (an ingredient in your product) … it’s being studied for its protective benefits against cancer. [S]tudies have shown that lung and cervical cancer patients have lower levels of Alpha Carotene in their blood. Added to MDR Fitness Tabs it provides a wholesome natural carotenoid complex.”
In addition, typing the key word “cancer” or “diabetes” into your product search field located on your website brings up your product lists to include Fitness tabs for Men, Longevit – E and others, implying your products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.
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 the drug is safe and effective.
Dietary Supplement CGMP Violations
Even if your products did not contain disease claims in their labeling that cause them to be drugs, they would still be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements, as described below. Note that your firm’s status as a repacker of dietary supplements does not exempt you from having to comply with those regulations in 21 CFR Part 111 that are directly applicable to the operations that you perform.
1. You failed to make and keep written procedures for maintaining, cleaning, and sanitizing equipment and utensils that are used to package, label, or hold components or dietary supplements, as required by 21 CFR 111.35(b)(1)(iii). Specifically, your firm does not have a standard operating procedure for the cleaning and maintenance of the SwiftPack Automation LTD, which is used to fill bottles of dietary supplements.
We have reviewed your response, dated August 14, 2012, and found it to be inadequate. You state that the procedure would be “redone” by September 30th, 2012. Your response, however, does not indicate how you will implement a corrective action to this violation, nor does it address your ongoing cleaning practices or include copies of the required written procedures.
2. You did not make and keep documentation of the date of use, maintenance, cleaning and sanitizing of equipment in individual equipment logs, unless such documentation is kept with the batch record, as required by 21 CFR 111.35(b)(2). Specifically, your firm does not have documentation of cleaning for the SwiftPack Automation LTO, which is used to fill bottles of dietary supplements. Your response, dated August 14, 2012, does not indicate how you will correct this, and you did not include any records with your response demonstrating that you are now making and keeping the required documentation.
The violations cited in this letter are not intended to be an all-inclusive list of violations which 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 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/or 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 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.
You are requested to notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. With your response, include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time in which the corrections will be completed.
Please send your reply to Carla A. Norris, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. Any questions you may have regarding this process should be directed to Ms. Norris at (407) 475-4730.
#USFDA #FDA #foodanddrug #Dietarysupplement #elainehastings @elainehastings #GMP #diet #CGMP