| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
July 7, 2011
WARNING LETTER NYK-2011-28
Ms. Helen Chian, President
Confidence Inc.
138 Haven Ave Ste 101
Port Washington, NY 11050
Dear Ms. Chian:
On October 25 to 29, 2010 and on November 2,2010, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 138 Haven Ave Ste 101, Port Washington, New York. During the inspection, you informed our investigators that your firm is an own-label dietary supplement distributor that has entered into agreements with contract manufacturers to manufacture your dietary supplement products. You stated that these contract manufacturers are required to meet your firm's dietary supplement specifications. Further, you stated that your firm is ultimately responsible for marketing and distributing your finished dietary supplement products. As an own-label dietary supplement distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm's name, FDA considers you to be a manufacturer of such dietary supplements. As such, you have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.
During the inspection, our investigators found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
As a result, your dietary supplement products are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 343(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the current good manufacturing practice regulations for dietary supplements in 21 CFR Part 111. You may find the Act and the CFR through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. Your firm did not establish specifications for each component that you use in the manufacture of your dietary supplements, as required in 21 CFR 111.70(b). Specifically, your firm failed to establish any specifications for the gelatin capsules used in the manufacture of your dietary supplements, as required by 21 CFR 111.70(b). Your firm must establish specifications for the components it uses to manufacture a dietary supplement, regardless of whether your firm contracts with another firm to manufacture the components [See 72 Fed. Reg. 34752,34843 (Jun. 25, 2007)].
2. Your firm did not establish specifications for your dietary supplement labels, as required by 21 CFR 111.70(d). During the inspection, you provided our investigators with partial specification sheets for the following products: Glucosamine Plus tablets, Full Bloom tablets, Modelslim capsules, Fe-Mon-9 capsules and pH Balance tablets. However, the specifications for these products did not include labeling specifications, as required by 21 CFR 111.70(d).
3. Your firm did not make and keep written procedures for the responsibility of quality control operations, as required by 21 CFR 111.103 and 21 CFR 111. 140(b)(1). Your firm has an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm's quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled in accordance with established specifications, as required by 21 CFR 111.105 and 21 CFR 111.120(b).
4. Your firm did not establish any written procedures for holding and distributing operations, as required by 21 CFR 111.453. Your firm must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected [21 CFR 111.455(a)]. Further, your firm must hold components and dietary supplements under conditions that do not lead to the mix-up, contamination, or deterioration of components and dietary supplements [21 CFR 111.455(c)]. However, your firm did not establish any written procedures for holding and distributing components and dietary supplements, including written procedures for holding and distributing components and dietary supplements under appropriate conditions of temperature, humidity, and light, and under conditions that do not lead to mix-up, contamination, or deterioration.
5. Your firm did not 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). For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container-closure system in which the packaged and labeled dietary supplements were distributed products [21 CFR 111.83(b)(1)]. Further, the reserve samples must be identified with the appropriate batch or lot number for at least one (1) year past the shelf life date (if shelf lift dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with a reserve sample [21 CFR 111.83((b)(2)-(3)]. However, your firm failed to collect or hold any reserve samples of the dietary supplements that you distribute.
Unapproved New Drugs
During the inspection of your facility, we collected labeling for your products, including product labels and promotional brochures that your firms provides to customers along with their orders. In addition, we reviewed your website at www.confidenceusa.com. We have determined that the products listed below are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims in your labeling, including your product labels, accompanying promotional literature, and website, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.
Examples of some of the claims observed on the labels for your products, accompanying promotional literature, and your website include, but are not limited to, the following:
Dr. Brain with Huperzine A (30 capsules)
• "Dr. Brain is ideal for helping people with Alzheimer's "
• "Dr. Brain ... help[s] patients with 'Senile Dementia' "
• "Dr. Brain enhances the permeability of the membrane of the brain to enhance brain cell activity that enables "Alzheimer's disease" patients to experience relief from their symptoms and effectively prevent a deteriorating condition."
• "Dr. Brain is more capable of helping patients with senile dementia."
• "Dr. Brain has been found to support the delaying of ... extreme dementia."
pH Balance (30 tablets)
• "If taken correctly, ... diabetic symptoms will improve, and recurrence of diabetes would be significantly reduced."
• "Reduces cholesterol levels in the blood (especially low-density lipoprotein (LDL) levels ...."
• "pH Balance ... can effectively address the symptoms of diabetes for a more manageable and healthy life. This powerful combination of herbs works synergistically to help improve glucose metabolism thus regulating blood sugar levels."
• "It also improves the pancreas' capability to stabilize blood sugar levels, which may help to end the causes of 'Type II Diabetess' [sic]."
• "[I]mproving the health of patients with diabetes, and recurrence of diabetes would be reduced."
• "Reduces diabetes-induced occurrences such as Omentum Inflammation, Atherosclerosis, Kidney Dysfunction."
The accompanying promotional literature for this product includes the following claims in question and answer form:
"Q: Does the use of ph Balance help diabetes patients to recover?"
"A: Yes, 'pH balance' can help one to recover in 4 steps.
1. It takes 2 weeks to take effect
2. After 1 month of use, normal blood sugor [sic] stabilizes.
3. After 6 months of use, one may start reducing dosage
4. Within 12-24 months of use, most people's body start to regulate own health and blood sugar level"
"The biggest advantage of 'pH balance' is that it not only reduces blood sugar, but also effectively resumes the function of organs and health affected by high blood sugar. Also it reduces diabetes-induced retinitis, arteriosclerosis, kidney dysfunction, lower gangrenous limbs, and weakened body immunity. Positively, its good effect can lead diabetes patients to the road of recovery."
Glucosamine Plus (60 tablets)
• "Curcumin and Boswellia [ingredients in your product] are powerful anti-inflammatory herbal extracts that work like natural joint protectors to fight off joint pain."
• "Glucosamine Plus Indications Ideal For: Cervical Spondylosis; Periarthritis Scapulohumeralis; Osteoarthritis of Elbow Joint; Osteoarthritis of Carpal Joint; Osteoarthritis of Hip Joint; Osteoarthritis of Knee Joint; Osteoarthritis of Ankle Joint."
• "Glucosamine Sulfate [an ingredient in your product] ... prevents or reverses the degradation of joints."
In addition, we have reviewed the labeling for your Full-Bloom Topical Breast Cream product, including the product label and the accompanying promotional literature. We have determined that this product is a drug as defined by section 201 (g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] because the claims made in the labeling for this product indicate that it is intended to affect the structure or function of the human body by inducing breast growth.
Examples of some of claims made in the labeling for your Full-Bloom Topical Breast Cream product include:
• "Full-Bloom ... effectively induce[s] natural breast growth."
• "[H]elps a women achieve natural breast enlargement ...."
• "It can increase breast size quickly...."
• "Promotes fuller and more balanced breasts..."
• "Full-Bloom ... works by helping the body to naturally produce estrogen and improve blood circulation in the breast area resulting in bigger, firmer and fuller breasts."
• "[H]elps mammary glands grow and develop ...."
• "Rapidly gains fuller size from A to D cup, after constant use for 6 - 12 months"
• "Only Full Bloom provides you the natural, safe, and fastest way to stimulate tissue growth, resulting in bigger, firmer and fuller breasts."
Your Dr. Brain with Huperzine A, pH Balance, Glucosamine Plus, and Full-Bloom Topical Breast Cream 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)]. 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. 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)].
We received your response to the FDA 483 observations, which was issued to you at the conclusion of the inspection. Your response was dated November 5, 2010 and received in the district office on November 18, 2010. We have reviewed your response and determined that it is inadequate because you did not provide any documentation to support your assertion that you would make corrective actions.
Further, your response indicated that you would develop a suppliers' survey to qualify your suppliers. However, development of a suppliers' survey will not satisfy the requirements of section 21 CFR 111.75(a)(2). In order to rely on a certificate of analysis from the supplier of a component that you receive, you must first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations [21 CFR 111.75(a)(2)(ii)(A).
This letter is not meant to be an all-inclusive list of the violations at your facility. You are responsible for ensuring that your facility and products comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, such as seizure or injunction.
In addition, we note the following:
• Your firm provides some dietary ingredients to contract manufacturers to manufacture your Model Slim, pH Balance, Full-Bloom, Glucosamine Plus and Femon-9 dietary supplements. Under 21 CFR 111.75(a), it is required that before using a dietary ingredient as a component in the manufacture of a dietary supplement, at least one appropriate test or examination be conducted to verify the identity of the dietary ingredient. You firm failed to maintain any documentation showing that appropriate tests or examinations were conducted to verify the identity of the dietary ingredients for the dietary supplements listed above before the dietary ingredients were used in the manufacture of your dietary supplements. As noted above, your firm has an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution.
• Your firm receives certificates of analysis from your suppliers for dietary supplement components. Under 21 CFR 111.75(a)(2), a certificate of analysis may be used to confirm the identity of a component that is not a dietary ingredient and to determine whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met. In order to rely on a certificate of analysis from a supplier of the component, the requirements of section 21 CFR 111.75(a)(2)(ii) must be met. Some of these requirements include qualifying the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations, maintaining documentation of how the supplier was qualified, and periodically reconfirming the supplier's certificate of analysis [21 CFR 111.75(a)(2)(ii)(A),(C), and (D)]. In addition, the certificate of analysis must include a description of the test or examinations methodes) used, limits of the test or examinations, and actual results of the tests or examination [21 CFR 111.75(a)(2)(ii)(B)]. However, a certificate of analysis may not be used to verify the identity of a component that is a dietary ingredient. Instead, 21 CFR 111.75 (a)(1) requires that before using a component that is a dietary ingredient, at least one appropriate test or examination be conducted to verify the identity of the component, unless FDA grants an exemption from such testing under 21 CFR 111.75(a)(1)(ii).
• Our review of your records indicates that several customers have returned dietary supplements to your firm based on a variety of complaints. However, your firm has not established any written procedures for returned dietary supplements, as required by 21 CFR 111.503. For example, under 21 CFR 111.510, your firm must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision. Further, your firm must establish and follow written procedures to fulfill this requirement [21 CFR 111.503].
• Our review of your records indicates that the product complaints that you have received are not reviewed by your quality control personnel. Your quality control personnel must review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury [21 CFR 111.560(a)(1)]. Further, during the inspection, you told our investigator that when your firm receives a product complaint you only perform an investigation if you have a serious issue, such as a health issue, injury, life-threatening event, or report of hospitalization or medical care was reported.
Your quality control personnel must investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111 [21 CFR 111.560(a)(2)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. 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 reply to the Food and Drug Administration, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
Sincerely,
/S/
Ronald Pace
District Director
New York District
No comments:
Post a Comment