Inspections, Compliance, Enforcement, and Criminal Investigations
Global Source Management & Consulting 9/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
September 10, 2012
Mr. Gary R. Dubin
Global Source Management & Consulting
4541 North Pine Island Road
Sunrise, FL 33351-8718
Dear Mr. Dubin:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 4541 North Pine Island Road, Sunrise, Florida from January 19, 2012 and March 15, 2012. During the inspection, our investigators collected labeling for your products and evaluated the manufacturing of several of your products, which you label as dietary supplements, including your Scientific Joint Program capsules, Alpha Lipoic Acid sustained release tablets, Healthy Blood Sugar Diabetic Support and Enteric Coated Max Omega-3 products. Based on our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
Unapproved New Drugs
Based on our review of the labeling for your products listed below, we have determined that these products are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The claims in the labeling for these products 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 some of the claims observed in your product labeling include:
Scientific Joint Program capsules
- “The Best Arthritis Formula***ENJOY LIFE AGAIN WITHOUT PAINFUL JOINTS***Experience Profound Relief And Fluidity Of Motion***”
Chondroitin A Sulfate (an ingredient in the product)
- “[R]etards the growth of new blood vessels that cause inflammation.”
Glucosamine Sulfate (an ingredient in the product)
- “[T]o rebuild healthy cartilage.”
Turmeric (95% Curcumin) (an ingredient in the product)
- “It has powerful anti-inflammatory properties while also providing protection against irritation for the stomach lining ...”
Sea Cucumber (an ingredient in the product)
- “[L]iterally melt arthritis pain away. It takes up to sixty days for sea cucumber to create and then maintain proper inflammatory response”
Green tea extract (an ingredient in the product)
- “[H]as demonstrated effectiveness against cancer cells in the test tube....”
Devils Claw Extract (an ingredient in the product)
- “This African herb fights both pain and inflammation of the joints and also lowers uric acid.”
Ginger Root Powder (an ingredient in the product)
- “Helps many areas … specifically for Arthritis it helps relieve inflammation….”
Alpha Lipoic Acid
- “[S]hown to . . . increase sensitivity to insulin … helps protect against mercury and poison mushroom toxicity … helps protect inner ear from drug toxicity”
Healthy Blood Sugar Diabetic Support
- “Diabetic Support”
Dr. Balch’s Prostate Support
- “With a staggering percentage of the male population suffering from some form of prostate related ailment…. [P]rostate Support … works collaboratively to offer an unparalleled level of prostate protection.”
High Potency Evening Primrose Oil
- “May be beneficial for … psoriasis”
Excess Water Pill Natural Herbal Diuretic
- “Natural Herbal Diuretic”
- “Many herbs can be beneficial if you are suffering from edema….”
- “Juniper berries and Uva ursi are both potent diuretics that increase the output of urine, and help correct edema.”
- “Parsley also has diuretic properties….”
High Potency Evening Primrose Oil
- “May be beneficial for psoriasis”
Ginkgo Biloba Standardized Extract
- “May slow Alzheimer’s progression … May aid a variety of disorders that are circulation related including tinnitus (ringing in the ears), and impotence.”
Maca Lepidium Meyenii
- “Good for anemia, chronic fatigue syndrome, impotence.…”
- “Peru’s Natural Viagra”
Enteric Coated Max Omega-3
- “[R]ecognized as a healthy anti-inflammatory.…”
Super Horny Goat Weed
- “Studies have also shown this traditionally used kidney disease herb ... also improved quality of life in patients with Chronic Renal Failure.”
- “[R]educes mucus from colds. Good for … high blood pressure, insomnia, irritable bowel syndrome … pain … and ulcers”
Because these products are not generally recognized as safe and effective for the above referenced uses, they 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 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.
Furthermore, because your Scientific Joint Program capsules, Alpha Lipoic Acid sustained release tablets, Healthy Blood Sugar Diabetic Support products, Dr. Balch’s Prostate Support, Ginkgo Biloba Standardized Extract, Maca Lepidium Meyenii, and Valerian Root products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the product safely for its intended uses. Therefore, these products are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
Adulterated Dietary Supplements
In addition, even if your products, including those listed above, were not unapproved new and misbranded drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of 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 the Current Good Manufacturing Practice (CGMP) regulations 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:
- You failed to package and label dietary supplements in a way that ensures the quality of the supplements and that the supplements are packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.415. Specifically, during the inspection you verbally confirmed that your firm does not have a MMR for any of the dietary supplement products packaged and labeled by your firm.
- You failed to establish specifications for packaging and labeling dietary supplements to provide sufficient assurance that the product you receive is adequately identified and consistent with your purchase order, as required by 21 CFR 111.70(f). You also failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label. Specifically, during the inspection, you informed our investigator that you did not have any specifications for labeling and packaging dietary supplements. We note that once you have established such specifications, as required by 21 CFR 111.70(f) and (g), you must also determine whether the specifications have been met, as required by 21 CFR 111.73.
- 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, during the inspection, you informed our investigator that your firm did not have any written procedures for quality control operations.
- Your batch production record failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. During the inspection, you provided our investigator a copy of a “Packing Order” for Glucosamine Sulfate Chondroitin Sulfate with MSM Boron EPO, Lot# 385804, which you said was a representative batch record for each batch of dietary supplement packaged at your firm. However, this batch record did not contain the following required elements:
- The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
- The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines [21 CFR 111.260(c)].
- The unique identifier that you assigned to packaging used and the quantity of the labels issued and used [21 CFR 111.260(k)(1)].
- The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)].
- You failed to establish written procedures to fulfill the requirements of 21 CFR 111.560 relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, during the inspection you verbally confirmed to our investigator that there is no formal system in place to address product complaints. Your process at the time of our inspection included a quarantine area where all products with a complaint are kept, however you do not keep a written log of these formal complaints.
- You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, at the time of inspection you stated to our investigator that your firm does not maintain reserve samples of finished products that are packaged by your firm.
Misbranded Dietary Supplements
Further, even if your products listed below, were not unapproved new and misbranded drugs, they would be misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343].
Based on our review of the labeling for your products, we observed the following:
- Your Garlic 500 mg with Parsley, Glucosamine Sulfate Chondroitin Sulfate Complex (90 Softgels), Healthy Essential Oil and Prosta-Aid Double Strength (300 Softgels) are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labels contain false and misleading information regarding the presence of soy in the products. All of the products contain soy in their list of ingredients (i.e., soybean oil), but your labels also declare statements asserting that the products do not contain soy (i.e., “Contains … no soy”). If these products contain soy, statements made in the labeling for these products asserting that such products do not contain soy would be false or misleading. If these products do not contain soy, statements made in the labeling for these products asserting that such products contain soy would also be false or misleading.
- Your Alpha Lipoic Acid 600 mg (60 VCaps), Echinacea Root, Evening Primrose Oil (500 mg, 1000 mg), Ginkgo Biloba Standardized Extract 60 mg (60 Softgels, 300 Softgels), Glucosamine Sulfate Chondroitin Sulfate Complex (90 Softgels), Enteric Coated Max Omega-3 (60 Softgels), Omega-3 with Vitamin D3 (100 Softgels, 300 Softgels), Super Horny Goat Weed, Valerian Root, and C Vitamin (Ascorbic Acid) products are 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” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)).
- Your products Prosta-Aid Double Strength (60 Softgels, 300 Softgels), Super Horny Goat Weed, and Diabetic Support are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the labels fail to identify the part of the plant (e.g., root, leaves) from which the botanical dietary ingredients in the product are derived, as required by 21 CFR 101.4(h)(1). For example, your Prosta-Aid Double Strength lists Saw Palmetto and Diabetic Support lists Gymnema sylvestre, but they do not identify the part of the plants used.
- Your C Vitamin (Ascorbic Acid), Cod Liver Oil, Colon Super Cleanse (300 Capsules), Echinacea Root, Evening Primrose Oil 500 mg, Evening Primrose Oil 1000 mg, Flax Seed Oil, Lecithin, and Shark Cartilage products are misbranded under section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to include a complete domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The addresses provided are not complete with a street name and/or number.
The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in enforcement action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
In addition, we note the following:
- During the inspection, we noticed that you did not use adequate screening or other protection against pests, where necessary as required by 21 CFR 111.20(h). Specifically, our investigator observed visible gaps of approximately one inch in width on the right, top, and left sides of the rolling door at the south end of your facility. In addition, our investigator observed wood in poor repair on the lower right side of the rolling door on the south wall of the facility. Further, a live lizard approximately two feet from the packaging and labeling table was observed at the time of inspection. It was noted that an individual from the building management came between our visits and caulked up the door. While caulk may close up the opening in the interim, we recommend that your firm prepare and implement a sufficient corrective action that will be long-term.
- Your ceilings were not designed and constructed so that they can be adequately cleaned and kept clean and in good repair as required by 21 CFR 111.20(d)(1)(i). In particular, on 1/26/2012, our investigator observed damage from water on a ceiling tile over your raw ingredients storage area and in the restroom. In addition, on 2/22/2012, our investigator observed a collapsed ceiling tile from the roof lying on the restroom floor, providing a large opening in the ceiling. Water was dripping from this opening in the ceiling into a bucket at the time of inspection. Moreover, you stated to our investigator that the leaking roof has been an issue with the building management for approximately six months and though the ceiling tiles were replaced; the source of the leak coming from the roof has not been repaired.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. 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.
Please send your written reply to the Food and Drug Administration, Attention: Mr. Winston Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Emma R. Singleton
Florida District Office