Inspections, Compliance, Enforcement, and Criminal Investigations

Global Marketing Enterprises, Inc. 3/15/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

March 15, 2016
 
WARNING LETTER
 
CHI-3-16
 
 
 
DELIVERED VIA UPS NEXT DAY
SIGNATURE REQUIRED
 
Edwardo S. Chua
President/Owner
Global Marketing Enterprises
1801 S. Canal St.
Chicago, IL 60616
 
Dear Mr. Chua:
 
On May 21, 2015 through July 8, 2015, a U.S. Food and Drug Administration (FDA) investigator inspected your dietary supplement and seafood processing facility, located at 1801 S. Canal St. Chicago, IL 60616.  The inspection revealed that you have serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations Part 111 and the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123.  Accordingly, your dietary supplement, Garcinia cambogia is adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.  In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your frozen raw squid, farm raised head on shrimp, and round scads products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
 
We also reviewed the product labeling for your “Caffeine Powder” and based on our review of the labeling, we have determined that this product is promoted for conditions that cause the product to be a drug under Section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims made in the labeling for this product establish that your product is a drug because it is an article (other than food) intended to affect the structure or any function of the body.  As explained below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
In addition, we have reviewed your product labels collected during the inspection and we have determined that certain products identified below are in violation of Section 403 of the FD&C Act [21 U.S.C. § 343] and/or the regulations implementing the food labeling requirements of the FD&C Act, which are found in 21 CFR Part 101. 
 
To date, we have not received a response to the FDA-483, Inspectional Observations that was issued to your firm during the close out of the inspection on July 8, 2015.  You may find the FD&C Act and the Code of Federal Regulations (CFR) through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drug
 
Based on our review of the product labeling for your “Caffeine Powder”, we have determined that the labeling claims promote this product for conditions that cause it to be a drug under Section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because it is an article (other than food) intended to affect the structure or any function of the body. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. See, e.g., 21 CFR 201.128. 
 
Examples of claims from the product label indicating that “Caffeine Powder” is intended to affect the structure or any function of the body include, but may not be limited to, the following:
  • “Pure caffeine powder is a powerful stimulant . . . .”
  • “It is a powerful stimulant . . . .”
The above-mentioned claims cause the product “Caffeine Powder” to be a drug under Section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. Furthermore, this product is a “new drug,” as defined by Section 201(p) of the Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under Sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There is no FDA-approved application in effect for the “Caffeine Powder” product. Consequently, the marketing and sale of this product violates these provisions of the Act.
 
Misbranded Drug
 
Additionally, your “Caffeine Powder” is a misbranded drug under Sections 502(a) and 502(f)(1) of the Act [21 U.S.C. §§ 352(a) and 352(f)(1)]. 
 
A drug is misbranded under Section 502(a) if its labeling is false or misleading in any particular. The “Caffeine Powder” product is misbranded within the meaning of Section 502(a) of the Act because the amount of “Caffeine Powder” claimed to be delivered using the included scoop is incompatible with the labeled dosage directions for use. The product label states to “[a]lways use the included 0.5cc scoop,” and the accompanying literature states that “[o]ne 0.5cc scoop (included) is about 230mg of caffeine (do not fill to the top),” “[d]o not exceed 200mg per serving,” and “[t]he recommended limit per dose of caffeine is 200mg (0.2g).” It is misleading to suggest to consumers that the provided scoop can be used to accurately measure the suggested serving size. FDA’s laboratory tested the scoop included with your “Caffeine Powder” product.[1] This testing revealed that the amount delivered by the included scoop does not accurately deliver the amount stated on the product labeling. Using a scant scoop the average dose delivered (134 mg) was approximately 67% of the label claim of 200 mg. Using a level or rounded scoop resulted in average delivered dosages of 291 mg (145% of label claim) and 597 mg (299% of label claim), respectively. Because the scoop is inconsistent with the labeled dosage directions, the labeling is false or misleading.
 
A drug is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). There is potential for serious adverse events associated with the use of your product. A single teaspoon of pure powdered caffeine is roughly equivalent to the amount in 28 cups of coffee (approximately 2.7 grams[2]). Consuming as little as one teaspoon of caffeine has been associated with symptoms including nausea, vomiting, anxiety, and heart palpitations. Consuming as little as one tablespoon (equivalent to 3 teaspoons or approximately 8.1 grams) of caffeine has been associated with symptoms including chest pain, hypokalemia, elevated blood glucose, tachycardia, bigeminy, agitation, respiratory alkalosis, irregular heartbeat, and in some cases, even death.
 
Therefore, your “Caffeine Powder” product is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because the product labeling does not contain sufficient information to enable laypersons to use this product safely and for the purposes for which it is intended (described above), including: frequency of administration, duration of administration, time of administration, route or method of administration, and preparation for use. (See 21 CFR §§ 201.5(c), (d), (e), (f) and (g)).  The introduction or delivery for introduction into interstate commerce of this misbranded drug violates Section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Dietary Supplements
 
1.    You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you failed to conduct at least one appropriate test or examination to verify the identity of Garcinia cambogia used in your Garcinia cambogia Powder Extracts supplement. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition. Your firm has not petitioned FDA for such an exemption.
 
2.    You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement. Specifically, you do not have specifications for the dietary supplement Garcinia cambogia that you package, label, and distribute, as required by 21 CFR 111.70(e). Once you have established such specifications, you must determine whether the specifications you establish under 21 CFR 111.70 are met. You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records, as required by 21 CFR 111.95.
 
3.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement your firm manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). You also do not prepare and follow an MMR that identifies specifications for the points, steps or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.205(b)(1). Specifically, you did not establish a written MMR that satisfies the requirements of 21 CFR 111.210 for the dietary supplement, Garcinia cambogia that you manufacture, package, label, and distribute.
 
4.    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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you do not have any processes, specifications, written procedures, tests, or examinations that have been reviewed and approved by quality control, nor have you established written procedures for quality control personnel to follow. Additionally, you failed to perform required quality control operations to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement, namely Garcinia cambogia, and that your dietary supplement products are packaged and labeled as specified in the MMR, as required by 21 CFR 111.105.
 
5.    You must establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c). Specifically, during our inspection it was observed that you do not have sanitization procedures established, and on 5/21/15, our investigator observed that your capsule filling machine had not been cleaned from earlier production use and was (b)(4). Once you have established the sanitizing procedure you must implement it by maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d), and make and keep sanitization records as required by 21 CFR 111.35(a).
 
Misbranding Dietary Supplements
 
6.    Your Garcinia cambogia powder extracts product is 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 or labeling of the supplements fails to identify the products by using the term “dietary supplement,” which the term may be modified with the name of such an ingredient in the product or an appropriately descriptive term, as required by 21 CFR 101.3(g).
 
7.    Your Garcinia cambogia powder extracts product is misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the product fails to bear nutrition information (“Supplement Facts” label) in accordance with 21 CFR 101.36 and it is not exempt from this requirement.
 
Seafood HACCP Violations
 
8.    You must conduct or have conducted a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR Part 123.6(a) and (b). However, your firm does not have a HACCP plan for your frozen raw vacuum packaged squid, round scad, and farm raised head on shrimp to control the food safety hazards of Clostridium botulinum growth and toxin formation and/or undeclared sulfiting agents.
  • With regard to the hazard of Clostridium botulinum growth and toxin formation, our investigator noted during the inspection that your firm was repackaging frozen raw squid, round scad, and farm raised head on shrimp into hermetically heat sealed plastic bags (i.e., reduced oxygen packaging). Your firm’s HACCP plan should ensure that each individual package of finished product is labeled with instructions to keep frozen and thaw under refrigeration immediately before use (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use").
  • With regard to undeclared sulfiting agents, our investigator noted during inspection that your farm raised head on shrimp labeling did not declare sulfites. The supplier was contacted and confirmed shrimp was treated with (b)(4) sulfites. Your firm’s HACCP plan should ensure that sulfiting agents are accurately declared on your product labels. We recommend you include a critical control point in your HACCP plan to visually check the finished product packages for labels to ensure sulfiting agents are properly declared on the label. 
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the dietary supplement CGMP regulations, and the seafood HACCP regulation (21 CFR Part 123).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
We also note, that your firm failed to establish identity specifications for each component that you use in the manufacture of your dietary supplement products, and failed to establish component specifications as necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b). Specifically, during the inspection, you told our investigators that your firm has not established any specifications for the components that your firm uses in the manufacture of your dietary supplement products.
 
In addition, your website at www.lifelinenutrients.com lists several Garcinia cambogia capsule products. The labeling for each of these products appears to be similar to the Garcinia cambogia powder extracts product label and should bear the same information noted above pertaining to the Garcinia cambogia powder extracts product (21 CFR 101.3(g) and 21 CFR 101.36).
 
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 from the responsible party of the domestic facility. 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 re-inspection-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 re-inspection-related costs.
 
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. You should include in your response documentation such as testing records, manufacturing records, sanitation records, a HACCP plan, seafood verification documentation, labeling, and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please submit your response to: Lauren Crivellone, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 480897) when replying. If you have any questions about the content of this letter, please contact Ms. Crivellone at 312-596-4157 or email lauren.crivellone@fda.hhs.gov.
 
                                                                       
Sincerely,
/S/ 
William R. Weissinger
District Director


[1] This test was performed in accordance with USP Physical Test 905, Uniformity of Dosage Units (USP version 38, official through 30-Nov-2015). This method provides a statistical test for determining the “acceptance value” for a set of data. The amount delivered by the included scoop failed the USP Physical Test 905, Uniformity of Dosage Units, because the weight variation is outside of the acceptance value.
[2] The USDA nutrition database reports that one cup (8 oz.) of ground coffee contains 95 mg of caffeine: http://ndb.nal.usda.gov/ndb/foods/show/4277?manu=&fgcd=

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