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FDA Not Confident in Confidence Inc.s Ops
August 30, 2011
8 Min Read
JAMAICA, N.Y.Confidence Inc., an own-label dietary supplement distributor that uses contract manufacturers to make its supplements, received a warning letter from FDA that said the company violated a number of the cGMPs (current good manufacturing practices), labeling requirements and other legal obligations.
During an inspection of Confidences Port Washington, NY, facility on Oct. 25 to 29, 2010 and on Nov. 2, 2010, Confidence said it does make its supplements; however, FDA said because Confidence distributes and markets its own supplements, the agency considers it to be a manufacturer and thus has responsibility for the dietary supplements that it sells.
FDA said it found serious violations" related to manufacturing, packaging, labeling and holding operations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). As a result, FDA said Confidences dietary supplement products are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. § 343(g)(1)].
Specially, FDA said it found Confidence did not do the following cGMPs:
Establish specifications for the gelatin capsules used in the manufacture of its dietary supplements, as required by 21 CFR 111.70(b).
Establish specifications for its dietary supplement labels, as required by 21 CFR 111.70(d); during the inspection, FDA said it received partial specification sheets for 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).
Make and keep written procedures of quality control (QC) operations, as required by 21 CFR 111.103 and 21 CFR 111. 140(b)(1). FDA said manufacturers QC personnel must ensure that its manufacturing, packaging, labeling and holding operations ensure the quality of its dietary supplements and that its dietary supplements are packaged and labeled in accordance with established specifications, as required by 21 CFR 111.105 and 21 CFR 111.120(b).
Establish written procedures for holding and distributing operations, as required by 21 CFR 111.453. The 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)], according to FDA. Further, Confidence 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)].
Collect and hold reserve samples of each lot of packaged and labeled dietary supplements that it distributes, as required by 21 CFR 111.83(a). These reserve samples must be identified with the appropriate batch or lot number for at least one year past the shelf life date (if shelf lift dating is used), or for two years from the date of distribution of the last batch [21 CFR 111.83((b)(2)-(3)].
FDA also found Confidences labels, promotional brochures and website contained wording that promoted products for use in the cure, mitigation, treatment or prevention of disease, which causes them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].
FDA highlighted the following claims for specific products:
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."
"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."
Full-Bloom Topical Breast Cream:
"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."
Because Dr. Brain with Huperzine A, pH Balance, Glucosamine Plus and Full-Bloom Topical Breast Cream products are not GRAS (generally recognized as safe) and effective for the above referenced uses, FDA said, the products are "new drugs" under section 201(P) of the Act [21 U.S.C. § 321(P)]. 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)].
CofA Issues
After FDAs inspection it issued a 483 observation, which Confidence responded to on Nov. 5, 2010, according to the warning letter. This response, however, was inadequate, according to FDA, because the company did not provide documentation to support its assertion that it would make corrective actions. While Confidence said it would develop a suppliers' survey to qualify its suppliers, FDA said this would not satisfy the requirements of section 21 CFR 111.75(a)(2). In order to rely on a certificate of analysis (CofA) from the supplier of a component that a company receives, the company must first qualify the supplier by establishing the reliability of the supplier's CofA through confirmation of the results of the supplier's tests or examinations [21 CFR 111.75(a)(2)(ii)(A), according to FDA.
The agency said Confidence failed to maintain any documentation showing that appropriate tests or examinations were conducted to verify the identity of the dietary ingredients for its Model Slim, pH Balance, Full-Bloom, Glucosamine Plus and Femon-9 dietary supplements. Under 21 CFR 111.75(a), FDA noted 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. Further, FDA said a CofA is not sufficient to verify the identity of a component that is a dietary ingredient.
Returns/Complaints
FDA said records indicated several customers have returned dietary supplements to Confidence based on a variety of complaints. However, Confidence had not established written procedures for returned dietary supplements, as required by 21 CFR 111.503. Further, product complaints that the company received were not reviewed by its QC personnel. During the inspection, FDA said Confidence told the investigator that it only performs an investigation if it receives a report of a serious issue, such as a health issue, injury, life-threatening event, or report of hospitalization or medical care. Per 21 CFR 111.560(a)(1), QC 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.
FDA gave Confidence 15 working days from receipt of the warning letter to outline the specific things it is doing to correct the violations.
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