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WARNING LETTER

Mannatech Incorporated MARCS-CMS 521321 —

Delivery Method:
UPS
Recipient:
Recipient Name
Alfredo Bala
Mannatech Incorporated

600 South Royal Lane
Coppell, TX 75019
United States

Issuing Office:
Dallas District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

 
 

 

November 14, 2017
 
2018-DAL-WL-2
 
WARNING LETTER
 
UPS Overnight
 
Alfredo Bala, President
Mannatech Incorporated
600 South Royal Lane
Coppell, Texas 75019
 
Mr. Bala:
 
From December 28, 2016 through January 13, 2017, the U.S. Food and Drug Administration (the FDA or we) inspected your facility located at 600 South Royal Lane, Coppell, Texas, where our investigators found a number of violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under insanitary conditions that do not meet CGMP regulations for dietary supplements.
 
Additionally, in May 2017, we reviewed the labeling for your products, including product labels and the websites at www.mannatech.com and www.mannatechscience.org. Based on our review, we have concluded that certain products are in violation of sections 403 and 505(a) of the Act [21 U.S.C. §§ 343 and 355(a)] and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
 
Unapproved New Drugs
 
We reviewed your BounceBack product label.  We also reviewed your websites at the Internet addresses www.mannatechscience.org and www.mannatech.com in May 2017, and have determined that you take orders there for the product BounceBack. The claims on your label and websites establish that the BounceBack product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. 
 
Examples of some of the claims made for your BounceBack product that provide evidence that it is intended for use as a drug include:
 
On the product label:
“Clinically shown to reduce soreness.”
 
On your website www.mannatech.com:
  • “Reduce soreness by taking BounceBack today!”
  • “Helps reduce muscle pain”
  • “Provides anti-inflammatory effects”
  • “BounceBack…ingredients…Reduce joint pain and inflammation”
  • “What is DOMS? It stands for delayed onset muscle soreness….BounceBack capsules can help reduce this soreness when taken daily over time.” 
On your website www.mannatechscience.org:
  • “Turmeric [an ingredient in the product]… has long been used…to ameliorate inflammation….has demonstrated anti-inflammatory activity….”
  • “BounceBack capsules reduced signs and symptoms of DOMS [delayed onset muscle soreness]….can reduce muscle pain….”
  • “helps reduce soreness….supports recovery from soreness…..helps ease soreness related to inflammation….”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
Adulterated Dietary Supplements
 
In addition, our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CMGP) regulations for dietary supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.  Additionally, even if your BounceBack product did not have therapeutic claims which makes it an unapproved drug, this product would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
 
1.    You failed to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, during the inspection, your finished product specifications for your Catalyst dietary supplement did not list specifications for identity, purity, and composition, and your finished product specifications for your Ambrotose Complex Powder dietary supplement did not list specifications for purity and composition.  Additionally, your product specifications fail to include the strength of each dietary ingredient in the products, and also do not include references to analytical procedures for the tests listed in the product specifications.
 
During the inspection, your firm told our investigators that your firm develops formulations for your dietary supplement products and approves product specifications and master manufacturing documents for your products.  You also told our investigators that the product specifications specialist assists with writing product specifications.
 
We have reviewed your response dated January 31, 2017; however, we are unable to determine the adequacy of your corrective actions. The response includes copies of revised finished product specifications for the dietary supplements Ambrotose Complex Powder and Catalyst.  Your response states that you updated your finished product specifications for Ambrotose Complex Powder and Catalyst dietary supplements to include “(b)(4)” testing for identity.  We note that you must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met. (21 CFR 111.320(b)).  We will evaluate the adequacy of your corrective actions at our next inspection.
 
We note that, to the extent that another firm manufactures, packages, and/or labels dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution.  [72 Fed. Reg. 34752, 34790].  Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act).
 
In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)).  Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).
 
2.    You failed to have your quality control personnel review and approve the decision about whether to investigate a product complaint, and review and approve the findings and follow-up action of any investigation performed, as required by 21 CFR 111.560(b). Specifically, while your firm initiates a review and investigation of all product complaints, your firm failed to have quality control personnel review and approve the findings and any follow-up action of any investigation performed.
 
We have reviewed your response dated January 31, 2017 and are unable to evaluate the sufficiency of your corrective action.  In your “Corporate Standard Operating Procedure” document, your written procedure indicates that “appropriate designee(s) from the Safety Monitoring in the Research and Development Department will hold primary responsibility for documentation, response, follow up and reporting” for your product complaints. Additionally, your “Quality Related Complaint Handling-Domestic and International” document states that “Quality Assurance personnel will close quality complaint once review/investigation of the quality complaint is completed,” which will include documentation of the review and approval of any findings or corrective actions related to an investigation of a product quality complaint.  We will evaluate the adequacy of your corrective actions at our next inspection.
 
Misbranded Conventional Food and Dietary Supplements
 
Additionally, your MannaBears, ImmunoSTART, TruSHAPE, and Catalyst products are misbranded undersection 403 of the Act [21 U.S.C. § 343] based on the following:
 
1.    Your MannaBears products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that in that their labeling is false or misleading.  Specifically:
 
a.  Your MannaBears product information sheet, “Deliciously Chewy Glyconutrients For the Kid in All of Us,” which is available on your website www.mannatech.com, where you take orders for your products, has the statement, “no artificial color.” However, according to the product label, the product contains fruit juice color and vegetable juice color.  FDA considers all added color, regardless of source, to be artificial, 21 CFR 101.22(a)(4).  The “no artificial color” statement on your product information sheet is misleading within the meaning of section 403(a)(1) of the Act because the addition of any added color results in an artificially-colored food.
 
b.  Your product labeling guide “Transform Your Wellness” contains the claim for your Catalyst product, “Provide 100% or more of the Daily Value of vitamins A, D, and E; and B complex vitamins, such as thiamin (B1), riboflavin (B2), niacin (B3), pantothenic acid (B5), B6, folic acid (B9) and B12; as well as calcium, magnesium, alpha-lipoic acid, choline, selenium, manganese, zinc and chromium.”  However, according to the product’s Supplement Facts label, the product does not contain 100% or more of the Daily Value of vitamins A and D, niacin, folic acid, calcium, magnesium, manganese, or zinc.  Therefore, the labeling for your product is false or misleading within the meaning of section 403(a)(1) of the Act.
 
2.    Your TruSHAPE product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labeling bears nutrient content claims, but the product does not meet the requirements to make such claims.  Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim.  Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l)(A) of the Act.  
 
Specifically, your website www.mannatechscience.org claims that your TruSHAPE product is an “antioxidant-rich formula.” The Supplement Facts label of your TruSHAPE product does not list any ingredients with an established Reference Daily Intake (RDI).  The antioxidant claim found on your website is a nutrient content claim because it bears the nutrient content claim “antioxidant-rich” formula but does not meet the requirements to make such a claim.  
 
Nutrient content claims using the term “antioxidant” must comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim, as required by 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, as required by 21 CFR 101.54(g)(2). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). Further, nutrient content claims using the term "antioxidant" must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)]. The antioxidant claim on your labeling does not indicate the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol.  The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
 
We note that there are alternative ways to convey the amount of the nutrients in your product to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). Percentage claims for dietary supplements may be stated in accordance with the requirements in 21 CFR 101.13(q)(3)(ii)(A) and (B). If you want to seek authorization to use your current claim, you may submit a petition requesting FDA to authorize a new nutrient content claim for one or more of the nutrients in your product (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.
 
3.    Your TruSHAPE, ImmunoSTART, and MannaBears products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Supplement Facts and Nutrition Facts label) does not comply with requirements in 21 CFR 101.36 and 21 CFR 101.9. For example:
 
a.  Your website www.mannatechscience.org contains the claim for your TruSHAPE product, “The fruits of most Capsicum species [an ingredient in the product] contain significant amounts of vitamins B, C, E…C. annum fruits are among the richest known sources of vitamin C.” 
 
A dietary ingredient, which has a Reference Daily Intake (RDI) or Daily Reference Value (DRV) as established in 101.9(c) (hereinafter referred to as “(b)(2)-dietary ingredient”), that is required to be declared in labeling must be declared when present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods (21 CFR 101.36(b)(2)(i)). Other vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) must be declared if added for purposes of supplementation, or when a claim is made about them. Id. Any (b)(2)-dietary ingredients that are not present or that are present in amounts that can be declared as zero in 101.9(c) must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Id.
 
We consider the statement “The fruits of most Capsicum species contain significant amounts of vitamins B, C, E” to subject this product to the requirements of 21 CFR 101.36(b)(2)(i) that require mandatory vitamins and minerals to be declared and certain other vitamins and minerals to be declared if added for purposes of supplementation or when a claim is made about them. However, we note the Supplement Facts label does not list vitamins B, C, or E.  Furthermore, to bear the claim “rich” source of a nutrient, the product must contain 20% or more of the RDI for nutrients under 21 CFR 101.54(b). 
 
b.  Your website www.mannatechscience.org contains statements for your ImmunoSTART product, such as, “Colostrum provides nutrients such as vitamins, minerals….[C]olostrum contains 3 to 4 times more protein than regular cow’s milk.”  Colostrum is an ingredient in your ImmunoSTART product.   
 
A (b)(2)-dietary ingredient that is required to be declared in labeling must be declared when present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods (21 CFR 101.36(b)(2)(i)). Other vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) must be declared if added for purposes of supplementation, or when a claim is made about them. Id.   Any (b)(2)-dietary ingredients that are not present or that are present in amounts that can be declared as zero in 101.9(c) must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals).  Id.
 
We consider the statements, such as, “Colostrum provides nutrients such as vitamins, minerals….[C]olostrum contains 3 to 4 times more protein than regular cow’s milk” to subject this product to the requirements of 21 CFR 101.36(b)(2)(i) that require mandatory vitamins and minerals to be declared and certain other vitamins and minerals to be declared if added for purposes of supplementation or when a claim is made about them. However, the ImmunoSTART Supplement Facts label does not list the vitamins, minerals, or protein referred to in the statements.  Furthermore, to bear the “more” claim of a nutrient, the product must contain at least 10% more of the RDI for vitamins or minerals or of the DRV for protein per reference amount customarily consumed than an appropriate reference food. In addition, the claim must be in accordance with 21 CFR 101.54(e).  
 
c.    Your website mannatechscience.org contains claims for your MannaBears product, including:
  • “Carrots [an ingredient in the product] are one of the richest vegetable sources of . . . beta-carotene.  Carrots are also a good source of vitamin K and a source of vitamin C, thiamin, niacin, vitamin B6, folate, manganese, dietary fiber and potassium.”
  • “Cauliflower [an ingredient in MannaBears] is an excellent source of vitamin C and a good source of vitamin K…”
  • “Kale [an ingredient in MannaBears]…is an excellent source of vitamin A, vitamin C, vitamin K and manganese…”
  • “Papayas [an ingredient in MannaBears] are an excellent source of vitamins A and C …”
  • “Pineapple juice powder [an ingredient in MannaBears] is also an excellent source of vitamin C and manganese…”
  • “Tomatoes [an ingredient in MannaBears] are an excellent source of vitamin A…also a good source of vitamin K…”
  • “Broccoli [an ingredient in the product]…excellent source of calcium, phosphorus, potassium, vitamin A and vitamin C….”
These claims include nutrients of the type required to be in nutrition labeling in your products.  However, the Nutrition Facts label of your MannaBears product fails to list vitamins A, B6, C, E, K, thiamin, iron, riboflavin, niacin, folate, calcium, phosphorus, biotin, manganese, beta-carotene, potassium, and dietary fiber, as required by 21 CFR 101.9(c)(8)(ii).  We note that to bear these claims, the food will also need to meet the nutritional requirements in the corresponding definition for that claim in 21 CFR 101.54.
 
d.    Your MannaBears product label fails to declare a serving size based on the reference amount customarily consumed (RACC) as required by 21 CFR 101.12(b), Table 2 and 21 CFR 101.9(b).  The serving size is declared as “4 Manna-Bears gums (10 g)" on the product label.  Based on this and the lack of a clear statement of identity, it is not clear whether this product is a candy or a chewing gum.  The RACC for candy product is 40 g “Sugars and Sweets: All other candies” and the RACC for chewing gum is 3 g (21 CFR 101.12(b), Table 2). Therefore, regardless of which RACC is appropriate, all of the nutrition information is also incorrect.  We also note that the asterisk following “% Daily Value” is missing [21 CFR 101.9(d)(6)].
 
4.    Your MannaBears product in misbranded within the meaning of section 403(i)(1) [21 U.S.C. § 343(i)(1)] in that the product label does not contain a statement of identity as required by 21 CFR 101.3. The term “MannaBears” is not an appropriately descriptive statement of identity. 
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. It is your responsibility to ensure your establishment is in compliance with all requirements of the Act and all applicable laws and regulations. You should take prompt measures to correct all violations described in this letter. Failure to do so may result in enforcement action by FDA without further notice, such as injunction or seizure. 
 
We also offer the following comments: 
 
1.    Although your TruPLENISH product is labeled as a dietary supplement, it is also represented as a conventional food through the label text “balanced meal supporting…wellness” and Fat-Loss System brochure claim “TruHealth…complete meal replacement full of vitamins, minerals, probiotics, enzymes, Glyconutrients and 20 grams of protein.” As defined by the Act, a dietary supplement does not include a product represented for use as a conventional food or as a sole item of a meal or the diet, per 21 U.S.C. § 321(f)(2)(B).
 
You can find additional information regarding dietary supplement labeling at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm
 
2.    Although your MannaBears product is labeled as a conventional food, we note that your website www.mannatechscience.org, contains statements for your MannaBears product such as, “A delicious, chewy, sweet supplement ...,” “A mouthwatering gummy bear supplement ...,” “Dietary supplement with the goodness of pomegranate juice and fruit and vegetable powders....,” and “A tasty supplement made in the shape of bears....” It is unclear whether you intend to market this product as a conventional food, or as a dietary supplement.  Please be advised that dietary supplements are required to be identified by the term “dietary supplement” as 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, per 21 CFR 101.3(g). There are other label requirements for dietary supplement products, also, including that labels must bear Supplement Facts labels, rather than Nutrition Facts labels, see 21 CFR 101.36.
 
3.    For your MannaBears product, we question why the fruit powders are listed together as a group and the vegetable powders are listed together as a group.  Please be advised that ingredients must be declared by their common or usual name in descending order of predominance by weight in accordance with 21 CFR 101.4(a)(1).  This regulation does not provide for grouping of fruit or vegetable powders unless it is received by the manufacturer as a single, premixed ingredient.  We also question why pineapple fruit juice is declared in the fruit powder group.
 
4.    The MannaBears product information sheet includes the disclaimer, "These statements have not been evaluated by the FDA.  These products are not intended to diagnose, treat, cure, or prevent any disease."  This type of disclaimer applies to the label or labeling of dietary supplements that bear a claim under section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] and 21 CFR 101.93(b) and should not be used on the label or labeling of conventional foods.
 
5.    The MannaBears product information sheet states “Gluten Free.”  You may wish to review our Questions and Answers: Gluten-Free Food Labeling Final Rule and the Final Rule, which was published on August 5, 2013, accessible at https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/allergens/ucm362510.htm.
 
6.    The MannaBears product information sheet found on www.mannatech.com and the website www.mannatechscience.org state that the MannaBears product is “a great source of Glyconutrients.”  However, “glyconutrient” does not appear to be a meaningful term that consumers would understand. The use of the term appears to be misleading. A term used in labeling must not misbrand the product within the meaning of sections 403(a)(1) and 201(n) of the Act. 
 
You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence of violations. In your response, you should include supporting documentation for your corrective actions. If you cannot complete all corrective actions before you respond, you should state the reason for your delay and state the date by which you will have completed the corrective actions. 
 
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection 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.
 
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
  
 
Sincerely,
/S/                                                           
Edmundo Garcia, Jr.
District Director
Program Division Director
Human & Animal Food Operations, WD3
  
 
CC:     
Texas Department of State Health Services
Mr. Greg Wilburn
Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756

 

 
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