Altasource LLC DBA Metalabs LLC 2/25/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office|
60 8th St., NE
Atlanta, GA 30309
February 25, 2013
Bassam Khayat, Owner
Altasource, LLC d/b/a Meta Labs LLC
1009 Mansell Rd., Suite L
Roswell, GA 30076-4816
Dear Mr. Khayat:
On July 17-20, 2012, the U.S. Food & Drug Administration (FDA) conducted an inspection of your dietary supplement and cosmetic manufacturing and distribution facility located at 1009 Mansell Rd., Suite L, Roswell, GA. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These CGMP violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)], in that the dietary supplements were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Our investigator’s observations were noted on Form FDA-483, entitled “Inspectional Observations,” which was issued to you at the close of the inspection.
In addition, we have reviewed the labeling of your products collected at the inspection and your website located at the Internet address www.metalabsllc.com and have determined that two of your products marketed as dietary supplements, “Respiratory Response” and “African Mango,” as well as two of your topical products, “Coffee Black Salve” and “Meta-Cell,” are promoted for conditions that 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 the labeling for these products establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. Further, your “Red Yeast Rice with CoQ-10” and “Conjugated Linoleic Acid” products are misbranded under section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. Additionally, even if your “Respiratory Response” and “African Mango” products, which are marketed as dietary supplements, were not drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], they would be misbranded under section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, found in 21 CFR Part 101. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the claims that cause your “Respiratory Response,” “African Mango,” “Coffee Black Salve,” and “Meta-Cell” products to be drugs as defined in section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] include, but are not limited to, the following:
Products Marketed as Dietary Supplements
- “Relief from Allergies, Asthma”
- “May also clear mucous and phlegm from allergens … or colds & flu that restrict normal breathing”
- “[D]eveloped to fight … shortness of breath and congestion from asthma, exercise induced asthma, emphysema, allergies, bronchitis, colds, and flu.”
- “Traditionally used to treat airway constriction due to asthma and other respiratory conditions.”
- “Active ingredients:”
o “Tylophora: Traditionally used to treat airway constriction due to asthma and other respiratory conditions.”
o “Codonopsis Pilosula: ... fights viral infections, coughs, and other respiratory conditions.”
o “Ginger: Uses include treating upper respiratory tract infections…bronchitis.”
- “[I]t’s highly effective in sequestering cholesterol and taking it out of your body.”
- “According to the Global In statute [sic] for Bioexploration, extract of the dikanut may help to alleviate diarrhea, diabetes, hernia and yellow fever”
- “Clinical studies also support the pit of African mango as a treatment aid for obesity and elevated levels of low-density lipoprotein, or LDL cholesterol.”
- “Albert Ayena, Ph.D….states that the oil contained in the fruit’s seed is abundant in beta carotene. National Institutes of Health explains that beta carotene is effective at preventing certain cancers, high blood pressure, infertility, heartburn and some emotional and mental disorders.”
“Coffee Black Salve,” which contains “caffeine extract” according to its label:
- “Can Coffee Fight Skin Cancer? READ OUR BROCHURE FOR MORE INFORMATION. With Coffee Black Salve you might have the help that you need to fight Skin Blemish and Skin Cancer”
- “Our research showed that…a special cream formula, performed beyond expectations in reducing Skin Blemish and Skin Cancer.”
- “[C]affeine acts selectively, causing the abnormal skin cells to die but not affecting the normal cells.”
- “Can Coffee Fight Skin Cancer? Skin cancer is the most common of all cancers…Generally skin cancer is curable by cutting, burning, or freezing the tumor cells but, if left untreated, it can be deadly. With Coffee Black Salve you might have the help that you need to fight Skin Blemishes and Skin Cancer!”
- “Coffee Black Salve’s caffeine cancer protection occurs inside the skin cells after exposure to the ultraviolet rays. We had a 50 to 70 percent inhibition of tumor formation in the mice that were treated with caffeine or EGCG (the chemical compound)”
- “[C]affeine apparently blocks the growth and development of abnormal cells by causing them to kill themselves, a type of programmed cell suicide that prevents development of abnormal growths. . . . . [T]he caffeine acts selectively, causing the abnormal skin cells to die but does not affect the healthy, normal cells.”
“Meta-Cell,” which contains “Glutathione Reduced” according to its label:
- “A combination that can help your body repair damage caused by …radiation, disease, infections, drugs, … aging, injury, trauma, and burns? Well, Meta-Cell Cream…has been specially created by Meta Labs just for that purpose!”
- “The best studies of Glutathione have been conducted in cancer patients. One study involved women with ovarian cancer who were being treated with chemotherapy... Those given the Glutathione not only had fewer side effects from the chemotherapy but also had better overall survival rates.”
Your products identified above 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.
Furthermore, your “Respiratory Response,” “African Mango,” “Coffee Black Salve,” and “Meta-Cell” 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 drugs safely for their intended purposes. Thus, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for their intended uses. Because your “Respiratory Response,” “African Mango,” “Coffee Black Salve,” and “Meta-Cell” products lack required approved applications, they are not exempt under 21 CFR 201.100(c)(2) and 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of “Respiratory Response,” “African Mango,” “Coffee Black Salve,” and “Meta-Cell” violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Also note that, even if your “Respiratory Response” and “African Mango” products were not unapproved new drugs under section 505(a) of the Act [21 U.S.C. § 355(a)], as dietary supplements they would be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)].
1. You failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing, to comply with 21 CFR 111.140(b)(1). Specifically, you have failed to establish any such written procedures for responsibilities pertaining to the quality control operations, including, but not limited to, reviewing the manufacturing, packaging, labeling, and holding operations for making disposition decisions. You have no procedures for reviewing and approving laboratory control systems, ensuring that any required tests are conducted, or reviewing results of tests and examinations.
2. You failed to establish and follow written procedures for returned dietary supplement, and you failed to identify and quarantine returned dietary supplement until quality control personnel conduct a material review and make a disposition decision, to comply with 21 CFR 111.503 and 21 CFR 111.510, respectively. Specifically, you stated that you received returned dietary supplement and redistributed the product on several occasions without documenting whether or how the product was evaluated prior to redistribution. Furthermore, you stated that if the product does not look adulterated, is sealed, and is within the expiration date, then it is redistributed, without any indication of quality control review.
3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, to comply with 21 CFR 111.205(a). Specifically, you indicated during the inspection that you actively manufacture approximately (b)(4) dietary supplements; however, you stated that you did not prepare an MMR for any of the dietary supplements you have manufactured. For example, your firm manufactured Meta-Gen Red Yeast Rice with CoQ-10 lot number F141201, but you failed to prepare or follow a written MMR for this dietary supplement. You must prepare and follow an MMR for all dietary supplement products that you manufacture that meet the requirements specified in 21 CFR 111.210.
4. You failed to make and keep records documenting why the results of appropriate tests or examinations for the product specifications selected under 111.75(c)(1) ensure that the dietary supplement meets all product specifications, to comply with 21 CFR 111.95(b)(4). You stated during the inspection that you conduct a visual examination of your finished products to check if they are mixed properly, and that you check the specific gravity and examine capsules, product weight, shape, formation, and taste. However, you did not provide written procedures or documentation that any of these tests and examinations was conducted. Furthermore, you failed to provide adequate documentation of your basis for determining that compliance with the stated specifications would ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of the dietary supplement, in accordance with 21 CFR 111.75(c)(3).
5. You failed to prepare a batch production record every time you manufacture a batch of dietary supplements to comply with 21 CFR 111.255(a). Specifically, you stated during the inspection that you do not have batch records for any of the dietary supplements that you have manufactured. You must create batch production records that include all elements of 21 CFR 111.260.
6. You failed to establish laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting standard reference materials used in performing tests and examinations to comply with 21 CFR 111.315(d). Specifically, you stated during the inspection that you compare the results of your tests and examinations to the previous lots or samples of the ingredient. However, you failed to use any criteria to establish a reference standard. Reference standards should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength.
7. You must make and keep records of the written procedures for manufacturing operations to comply with 21 CFR 111.375(b). You must also establish and follow written procedures for manufacturing operations to comply with 21 CFR 111.353. Your firm does not have any such written procedures for manufacturing operations. Such records are required to ensure your dietary supplements are manufactured in a manner that ensures product specifications are consistently met.
Misbranded Dietary Supplements
Your “Conjugated Linoleic Acid” and “Red Yeast Rice with CoQ-10” dietary supplements are misbranded under section 403 of the Act [21 U.S.C. § 343], as follows:
- Your “Conjugated Linoleic Acid” product is misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product is made from two or more ingredients and the label fails to declare each ingredient by its common or usual name, as required by 21 CFR 101.4. “Cis-9 Trans-11 isomer” and “Trans-10 Cis-12 Isomer” are not common or usual names for ingredients; both names are incomplete because they fail to identify the specific compounds in the dietary supplement.
- Your “Red Yeast Rice with CoQ-10” and “Conjugated Linoleic Acid” products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the nutrition information on their labels is not provided in the format specified in FDA’s regulations. For example, “other ingredients” (those that are not dietary ingredients) in a dietary supplement must be listed outside the Supplement Facts panel [21 CFR 101.4(g); see 21 CFR 101.36(e)].
- Your “Conjugated Linoleic Acid” product is misbranded under section 403(a)(1) because the label states that your product has 90 softgels; however, the serving size is listed as 2 capsules, and the number of servings per container is listed as 125. One or more of these label statements is false and misleading.
Additionally, even if the labeling for your “Respiratory Response” and “African Mango” products did not contain claims that cause them to be unapproved new drugs, as dietary supplements they would be misbranded under section 403 of the Act [21 U.S.C. § 343] for the following reasons:
- The label of your “Respiratory Response” lists the dietary ingredient “Prince Ginseng (Pseudostellaria heterophylla) root” in the Supplement Facts panel. Under section 403(u) of the Act [21 U.S.C. § 343(u)], a dietary supplement or other food is misbranded if it is represented as ginseng but is not derived from a plant classified within the genus Panax.
- The labels of your “Respiratory Response” and “African Mango” products list the “other ingredients” in these products within the Supplement Facts panel. Under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)], a food is misbranded unless it bears nutrition information in the format specified in FDA’s regulations, which require “other ingredients” to be declared outside the Supplement Facts panel, separate from nutrition information about dietary ingredients [21 CFR 101.4(g); see 21 CFR 101.36(e)].
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility. 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 that 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, such as seizure or injunction, without further notice.
Within 15 working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you are unable to complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
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 the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990 or write her at the noted address.
Atlanta District Office