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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pure Energy Products, Inc. 9/6/13

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

September 6, 2013 

 
2013-DAL-WL-047
 
WARNING LETTER
 
HAND DELIVERY
 
 
Darrin R. Clanton, Owner and President
Pure Energy Products, Inc.
6409 S. Western Avenue
Oklahoma City, OK 73139
 
Dear Mr. Clanton:
 
From October 10 through October 19, 2012, investigators with the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 6409 S. Western Avenue, Oklahoma City, Oklahoma.  During the inspection, our investigator noted that you distribute obestrim, which declares 1,3-dimethylamylamine [ab1] as a dietary ingredient. This ingredient is also called, among other names, dimethylamylamine, DMAA or methylhexanamine, and will be referred to in the rest of this letter as “dimethylamylamine”.  As explained below, dimethylamylamine is not a dietary ingredient. Rather, it is an unsafe food additive that causes your dimethylamylamine-containing product to be adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(i)] because it is a food to which dimethylamylamine, a drug approved under section 505 of the Act [21 U.S.C. § 355], has been added. 
 
In addition, we have reviewed the labeling for your Vivetra, Intensa, Cialafil (tiadalis), Zirex, and Phentrazine 37.5 products, including your product labels, promotional materials, and your websites at the Internet addresses www.vncstore.net and www.pillmedica.com in August 2013, at which sites you take orders for your Vivetra, Intensa, and Phentrazine 37.5 products.  Based on our review of the labeling for the above products, we have determined that these products 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 made in the labeling for these products establish that your products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Our inspection also revealed a number of significant violations of Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111), for the dietary supplement products that your firm distributes under its own label.  These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the the Act [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements.
 
Further, we have reviewed the labeling for your Acai Berry Blast, Intensa, RK SLIM, COLON-ES, T-SLIM 2000, Phentrazine 37.5, Zirex, obestrim, and ViaGOLD products.  Based on our review, we have concluded that your Colon-ES, T-Slim 2000, ViaGOLD, Acai Berry Blast, obestrim, and RK SLIM products are misbranded under section 403 of the Act [21 U.S.C. § 343] and regulations implementing the labeling requirements of the Act for dietary supplements and other foods, which are found in 21 CFR Part 101. Even if your Phentrazine 37.5, Intensa, and Zirex were not unapproved and misbranded drugs, they would be misbranded under section 403 based on violations of the labeling requirements for dietary supplements and other foods.
 
You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
 
Products Containing Dimethylamylamine
 
Your product obestrim is labeled and promoted as a dietary supplement. The label for this product declares dimethylamylamine as a dietary ingredient under the name “1,3 dimethylamylamine.” FDA does not agree that dimethylamylamine is a dietary ingredient as defined in section 201(ff) of the Act [21 U.S.C. § 321(ff)(1)].
 
At least one distributor of dietary supplements containing dimethylamylamine has argued that dimethylamylamine is a dietary ingredient under section 201(ff)(1) of the Act because (1) it is a constituent of a botanical, namely the geranium Pelargonium graveolens (P. graveolens), under section 201(ff)(1)(C) and (F); and (2) it is a dietary substance for use by man to supplement the diet by increasing total dietary intake, under section 201(ff)(1)(E).  FDA disagrees with both of these assertions.  Dimethylamylamine does not qualify as a dietary ingredient under section 201(ff)(1)(C) or (F) because dimethylamylamine is not an herb or other botanical, nor is it a constituent of a botanical.  Although some marketers of dimethylamylamine products have asserted that dimethylamylamine is present as a constituent of the geranium P. graveolens, FDA has reviewed the scientific literature on this subject and has concluded that the totality of the scientific evidence does not demonstrate the presence of dimethylamylamine in P. graveolens.[1] Therefore, dimethylamylamine is not a constituent of P. graveolens that could qualify as a dietary ingredient under section 201(ff)(1)(F). 
 
Additionally, dimethylamylamine does not qualify as a dietary ingredient under section 201(ff)(1)(E) of the Act because, to the best of FDA’s knowledge, no evidence exists that dimethylamylamine is a dietary substance for use by man to supplement the diet by increasing total dietary intake. Because the scientific evidence does not demonstrate the presence of dimethylamylamine as a constituent of geraniums, the possibility that geraniums may have been consumed as a food or drink by humans does not demonstrate that dimethylamylamine is a dietary substance.  Further, to the best of FDA’s knowledge, dimethylamylamine itself is not commonly used as a food or drink by humans.
 
Finally, dimethylamylamine does not qualify as a dietary ingredient under any other prong of section 201(ff)(1) of the Act. Dimethylamylamine is not a vitamin, mineral, amino acid, herb, or other botanical. Moreover, to the best of FDA’s knowledge, dimethylamylamine is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient. 
 
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition,[2]it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act. Adulterated foods cannot be legally imported or marketed in the United States.
 
Section 201(s) of the Act [21 U.S.C. § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the dimethylamylamine used in your products, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.
 
Dimethylamylamine is not generally recognized as safe under its conditions of use in your dietary supplement product. In fact, dimethylamylamine is known to have cardiovascular risks. It narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).  Because dimethylamylamine does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your obestrim product is adulterated under section 402(a)(2)(C)(i) of the Act because it contains an unsafe food additive. 
 
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)]. Further, it is a prohibited act under section 301(ll) of the Act [21 U.S.C. § 331(ll)] to introduce or deliver for introduction into interstate commerce any food to which a drug approved under section 505 of the Act has been added, unless the added drug was marketed in food before being approved under section 505.[3] Dimethylamylamine was approved as a drug in 1948 under section 505 of the Act and, to the best of FDA’s knowledge, was not marketed in food prior to such approval, either on its own or based on its alleged presence as a component of P. graveolens.  In the absence of such evidence, your obestrim product is in violation of section 301(ll) of the Act.
 
Failure to immediately cease distribution of your product obestrim and any other products you market that contain dimethylamylamine could result in enforcement action by FDA without further notice. The Act provides for seizure of violative products and injunction against the manufacturers and distributors of violative products.
 
Unapproved New Drugs
 
Your labeling - including the websites www.vncstore.net and www.pillmedica.com, at which you take orders for Vivetra, Phentrazine 37.5, and Intensa - promotes your Vivetra, Cialafil (tiadalis), Phentrazine 37.5, Intensa and Zirex products for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act. The therapeutic claims in your labeling establish that these products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease.   
 
Specific examples of therapeutic claims that provide evidence that your products are intended for use as drugs include:
 
Vivetra
  • “[t]he Ultimate Viagra alternative”
  • “[n]utraceutical alternative to Viagra”
  • “[m]ore powerful than the leading prescription drug prescribed for sexual problems”
  • “[g]et and obtain [sic] an erection”
[ab2] 
Cialafil (tiadalis)
  • (the name closely resembles the name of the drug Cialis)
  •  “[s]ay goodbye to erectile dysfunction”  
  • “[t]his is better than Viagra with out [sic] the headache and lasts longer”  
  • “[C]ialafil is the most effective and safest natural erection producing natural drug”  
 
The name and label of this product are similar to “Cialis”, a recognized brand of the prescription drug tadalafil. Cialis is manufactured by Eli Lilly and Company and is approved for use in treating erectile dysfunction.  Specifically, your name “Cialafil (tiadalis)” is similar to “Cialis” and “tadalafil”, and both Cialafil and Cialis have labels with a green and yellow swirl graphic design on a white background.  Such similarities may mislead consumers into thinking that your product “Cialafil” is an approved prescription drug that is effective for a medical condition such as erectile dysfunction.  
 
Phentrazine 37.5
  • (the name closely resembles the name of the drug Phentermine)
  • “Phentermine users, if you buy phentermine and need a refill, try Phentrazine 37.5.”  [ab3] 
  • “Phentrazine is a nutriceutical Alternative to Phentermine”
  • “[l]ike Phentermine and other diet drugs that have gone before it, Phentrazine 37.5 is potent”
 
Intensa
  • “[w]omen’s Viagra”
 
Zirex
  • “Can deliver real results without side-effects … no ED”  
  • “ZIREX is the most effective and safest natural erection producing natural drug…”  
 
Your Vivetra, Cialafil (tiadalis), Phentrazine, Intensa, and Zirex 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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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. 
 
Misbranded Drugs
 
Your products Vivetra, Cialafil (tiadalis), and Zirex [ab4] 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 drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].  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)].
 
Adulterated Dietary Supplements
 
The October 10-19, 2012 inspection of your facility revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your obestrim, COLON-ES, T-Slim 2000, [ab5] ViaGOLD, Acai Berry Blast, and RK SLIM products to be adulterated under section 402(g)(1) of the Act in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Additionally, even if your Vivetra, Cialafil (tiadalis), Phentrazine 37.5, Intensa, and Zirex products did not contain disease claims in their labeling that cause the products to be unapproved new drugs under section 505(a) of the Act, they would still be adulterated dietary supplements within the meaning of section 402(g)(1) because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. 
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, 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 with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
The following CGMP violations were observed during the inspection:
 
  1. 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, as required by 21 CFR 111.103 and 111.140(b)(1). Moreover, your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement, as required by 21 CFR 111.105. Specifically, you do not conduct quality control operations to ensure the quality of the dietary supplement you receive from your contract manufacturers, and you do not have written procedures for performing quality control functions within your facility.   

    Your firm must establish a system of production and process controls and implement quality control operations to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record (21 CFR 111.55 and 111.65). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement [21 CFR 111.127(h) and 111.140(b)(2)].

We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter, “PE Products will establish and follow written procedures for quality control operations. The quality control operations document will be on file for inspection by PE Products upon request.” However, you did not provide us with a copy of the quality control operations document. As such, we are unable to determine the adequacy of your proposed quality control operations.  
[ab6] 
 
  1. You failed to establish specifications for the labeling of the finished packaged and labeled dietary supplements that your firm labels, including specifications to ensure that you applied the specified label, as required by 21 CFR 111.70(g). During the inspection, you confirmed that you have no specifications or procedures in place to ensure that the correct labels are applied to each product. 
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter, “PE Products will commence an inspection process for all incoming products, either labeled or unlabeled, to ensure their identity.” You further state that “PE Products will confirm that each label is in compliance with. . . . GMP Guidelines” and that “PE Products will not be labeling any of their private labeled products received from this date.” However, you did not provide us with the specifications for the labeling that you perform. We will verify the implementation of this correction for any labeling operations you perform at our next inspection.
 
  1. You failed to conduct appropriate tests or examinations to determine whether specifications were met, as required by 21 CFR 111.75.
Specifically:
 
    • You failed to conduct a visual examination of labels and review the supplier’s invoice, guarantee, or certification to determine whether label specifications are met, prior to using the labels, as required by 21 CFR 111.75(f)(2).
    • You failed to conduct a visual examination of the labeling of the finished packaged and labeled dietary supplement to determine whether you applied the specified label, as required by 21 CFR 111.75(g).
 
You confirmed during the inspection that your firm maintains a label inventory for your brand name dietary supplement products and that the labels are not shipped along with unlabeled product from your contract manufacturers and packagers. You do not receive a Certificate of Analysis (COA), batch record, or any other production records with these shipments, other than shipping documents and invoices. The unlabeled bottles arrive at your facility sealed, and you have no specifications or procedures in place to ensure that the correct labels are applied to each finished dietary supplement product. 

We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response, “PE Products will commence an inspection process for all incoming products, either labeled or unlabeled, to ensure their identity.” You further state that “PE Products will confirm that each label is in compliance with . . . GMP Guidelines” and that “PE Products will not be labeling any of their private labeled products received from this date.” However, you did not provide us with information describing appropriate tests or examinations, as required by 21 CFR 111.75(f) and (g). We will verify the implementation of this correction for any labeling operations you perform at our next inspection.
 
  1. [ab7] You failed to prepare a batch production record relating to your labeling operations, as required by 21 CFR 111.255(a).  Specifically, you told our investigator that any of your products could be received unlabeled from your supplier, and your personnel have applied the labels to the products onsite. However, you have no records of these labeling activities.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that you will no longer receive unlabeled products, and that inventory received unlabeled before December 1, 2012 will be labeled in a clear, secure location and documented for inspection by PE Products upon request. You have not documented how you will correct the above violation for the labeling operations you perform.   
 
  1. You failed to make and keep records of the written procedures for labeling operations, as required by 21 CFR 111.430(b).  Specifically, you informed our investigator that you have no procedures to follow for the application of the labels to the unlabeled supplements that you receive, and that when any of your employees are not busy they will perform labeling operations as needed, without supervision or quality oversight.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that you will no longer be labeling any of your private labeled products at your facility and that all labels will be designed according to GMP guidelines and shipped directly to the manufacturing company. You further state that inventory received unlabeled before December 1, 2012 will be labeled in a clear, secure location and documented for inspection by PE Products upon request. You did not provide a copy of your written procedures for any remaining labeling operations you will perform at your facility and documentation that you implemented the procedures for unlabeled inventory. 
 
  1. You failed to control the issuance and use of labels and reconciliation of any issuance and use discrepancies, as required by 21 CFR 111.410(b).  Specifically, you do not have a controlled process for the issuance of dietary supplement labels within your facility, and you do not document what labels you have at any given time or the amount of labels available. Additionally, you do not reconcile the issuance and use of labels at your firm, and labels are not assigned a unique identifier for use in labeling operations at your facility. At your facility, the investigator observed loose labels on a shelf in an unsecured area of your facility where they are accessible to any persons who may be present in that area.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that you will no longer be labeling any of your private labeled products at your facility and that all labels will be designed according to GMP guidelines and shipped directly to the manufacturing company. You further state that inventory received unlabeled before December 1, 2012 will be labeled in a clear, secure location and documented for inspection by PE Products upon request. You did not, however, provide documentation relating to the process by which you will control the issuance and use of labels and reconcile any use discrepancies. 
 
  1. You were not able to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution, as required by 21 CFR 111.410(d). Specifically, you do not document or track the lot numbers of incoming or outgoing shipments of products that you distribute under your own brands.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that “PE Products will assign a qualified employee to supervise the labeling and holding of all dietary supplements. Said employee will be responsible for labeling and documenting each time labeling takes place.” However, you have not provided a description of the qualifications or the duties of the qualified employee or other documentation on which we can verify the adequacy of the correction.  
 
  1. You failed to make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint, as required by 21 CFR 111.570(b)(1).  Specifically, you informed our investigator that you have no written procedures for the review and investigation of a product complaint.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that “PE Products will file a consumer complaint log according to section 9 GMP guidelines.” However, you have not provided a copy of the written procedures for the review and investigation of a product complaint, and it is unclear what steps you will take to determine whether the complaint was due to an infraction of CGMP regulations, such as not meeting product specifications.
 
  1. You failed to make and keep written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1).  Specifically, you informed our investigator that you have no procedures for your holding and distribution operations.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that “PE Products will establish and follow written procedures for quality control operations. The quality control operations document will be on file for inspection by PE Products upon request.” However, you have not provided us with the written procedures for quality control operations, including how they relate to your holding and distribution operations.
 
  1. You failed to make and keep records of written procedures for fulfilling requirements for returned dietary supplements, as required by 21 CFR 111.535(b)(1).  Specifically, you informed our investigator that you have no written procedures to follow when dietary supplements are returned to your firm.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that “[r]eturned dietary supplements are examined for deterioration or contamination. If unopened and in resalable condition the dietary supplement will be restocked.” While obvious decomposition or deterioration of a product may be determined visually, a visual inspection cannot determine whether a dietary supplement product meets established specifications. Additionally, your response does not provide documentation of the written procedures you have established for fulfilling requirements for returned dietary supplements. 
 
  1.  You failed to collect and hold reserve samples of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a).  Specifically, you informed our investigator that you do not collect and hold reserve samples of any of the dietary supplement products you distribute.
 
We have reviewed your response letter, dated March 1, 2013, and determined your response to be inadequate. You state in your response letter that “PE Products will collect and hold samples and labeled dietary supplements of each private labeled product according to section 6 GMP guidelines. Each sample will have label with supplemental facts and lot number supplied by manufacturer. All samples will be stored under conditions that protect them from contamination or deterioration.” However, you did not provide any supporting documentation to demonstrate you are collecting and holding reserve samples. 
 
Misbranding
 
Even if your Phentrazine 37.5, Intensa, and Zirex were not unapproved new and misbranded drugs, they would be misbranded under section 403 of the Act (21 U.S.C. § 343) under section 403, as are your COLON-ES, T-Slim 2000, ViaGOLD, Acai Berry Blast, obestrim, and RK SLIM, in that the labeling for these products does not comply with the labeling requirements for dietary supplements and other foods, as follows:[ab8] 
 
  1. Your RK SLIM and Intensa products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1), 21 CFR 101.4(b) and 21 CFR 101.4(g). Specifically:
  • Your RK SLIM product contains ingredients that are not declared on the label, in that it is encapsulated, but capsule ingredients are not listed, and
  • Your Intensa product lists the generic ingredient description “pharmaceutical glaze”, which is not the common or usual name of any food ingredient.
 
  1. Your Acai Berry Blast, Intensa, RK SLIM, COLON-ES and ViaGOLD product labels are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information does not comply with 21 CFR 101.36. Specifically:
  • Your Intensa product label does not list “other ingredients” immediately below the nutrition label in accordance with 21 CFR 101.4(g). The label directions constitute intervening material within the meaning of 21 CFR 101.2(e) and should not be placed between the nutrition information and the ingredient listing of the information panel.
  • Your Acai Berry Blast and COLON-ES product labels list directions for use as well as manufacturer and distributor information within the supplement facts panel. This information is intervening material per 21 CFR 101.2(e) and should be listed outside the nutrition information panel.
  • Your ViaGOLD, Acai Berry Blast, and COLON-ES product labels list non-dietary ingredients within the Supplement Facts panel. These “Ingredients” should be listed outside and directly below the Supplement Facts panel in accordance with 21 CFR 101.4(g).
  • Your Acai Berry Blast and RK SLIM product labels do not bear symbols for the dietary ingredient, Acai Berry, that refers to the statement “* Daily Value not Established,” as required by 21 CFR 101.36(b)(3)(iv).
  • Your Acai Berry Blast product label fails to declare the quantitative amount of fat, fiber, or any minerals. When a claim about these nutrients is made, the amount of the nutrient present in a serving of the product must be declared, as well as the percentage of the daily value, as required by 21 CFR 101.36(b)(2)(i). Your label claims that the Acai Berry Blast product is “[a] synergy of monounsaturated (healthy) fats, dietary fiber and phytosterols” and “[a]n almost perfect essential amino acid complex in conjunction with valuable trace minerals.” These claims characterize the levels of nutrients of the type required to be in nutrition labeling in your products. The name of the nutrient, its quantitative amount by weight per serving, as well as the percentage of the daily value must be declared when they are added to the product for purposes of supplementation or when a claim is made about them, in accordance with 21 CFR 101.36(b)(2)(i).
 
  1. Your obestrim, T-SLIM 2000, COLON-ES, ViaGOLD and Intensa product labels are misbranded within the meaning of Section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] because the label fails to identify the part of the plant from which some of the dietary ingredients are derived in accordance with 21 CFR 101.4(h)(1). For example:
  • Your obestrim product label declares Semnostachya menglaensis, and Garcinia cambogia but not the part of the plants used to derive these botanical ingredients.
  • Your T-SLIM 2000 product label declares Guggul extract but not the part of the plant used to derive this botanical ingredient.
  • Your COLON-ES product label declares Cascara Sagrada and Senna but not the parts of the plants used to derive these botanical ingredients.
  • Your ViaGOLD product label declares Bombyx Mori L Extract, White Willow Extract, Jujube Extract, Cayenne Extract, and Stinging Nettles Extract but not the parts of the plants used to derive these botanical ingredients.
  • Your Intensa label declares Avena sativa and Horny Goat Weed extract but not the parts of the plants used.
 
  1. Your T-SLIM 2000, Phentrazine 37.5, and ViaGOLD product labels are misbranded under section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label fails to declare the place of business in accordance with 21 CFR 101.5.
 
  1. Your ViaGOLD and Zirex product labels are misbranded within the meaning of Section 403(u) of the Act [21 U.S.C. 343(u)] because the nutrition information of your labels lists the dietary ingredient Siberian Ginseng Extract. This herb ingredient is derived from the botanical Eleutherococcus senticosus. An herb or herbal ingredient can only be represented as ginseng if it is derived from a plant classified within the genus Panax. It is currently prohibited in the United States to market Eleuthero as Siberian Ginseng, since the term “ginseng” is reserved for the Panax species. Other examples include your Zirex product that lists the dietary ingredient Peruvian Ginseng from the botanical Lepidium meyenii Walp.
[ab9] [ab10] 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 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 without further notice, including, without limitation, seizure and/or injunction.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete all corrective actions within fifteen 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 re-inspection 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.
 
Please submit your response to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions please contact Ms. Essary at (214) 253-5335. 
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 


[1] FDA’s review of the scientific literature on this topic is summarized in a letter to USPlabs, LLC, dated April 18, 2013. The letter is posted on the agency’s website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm. 
[2] Under section 201(s) of the FD&C Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement. 
[3] Section 301(ll) also contains other exceptions not relevant here. See 21 U.S.C. § 331(ll)(2)-(4).

 [ab1]Note: This edit has been made with the concurrence of CFSAN to reflect the information on the product label.
 [ab2]Note: This claim has been removed at the request of CFSAN based on updates to the evidence from the firm’s websites. 
 [ab3]Note:  This claim has been removed at the request of CFSAN.
 [ab4]Note: The 502(f)(1) charges relating to Phentrazine 37.5 and Intensa have been removed, with concurrence from CFSAN. For Phentrazine 37.5, CFSAN identified an OTC product that acts in a similar manner to Phentrazine 37.5. For Intensa, there is no Rx-only disease associated with the sexual dysfunction for which use the product is being marketed. 
 [ab5]Note: T-Slim 2000 appears to have been left out of the original draft inadvertently. CFSAN concurs with referencing this product here.
 [ab6]Note: This violation has been moved to the beginning of this section for consistency with similar letters recently sent to distributors who contract out all portions of the manufacturing process. We have also added back in the 111.103 charge, which provides additional support. CFSAN concurs with these changes.
 [ab7]Note: This information has been incorporated into the first CGMP charge, above.
 [ab8]Note: Though this section of the letter generally falls outside the scope of OCC review, edits to this paragraph were made for consistency with the new and unapproved new drugs section of the letter.
 [ab9]Note: This portion of the letter is not subject to OCC review, and OCC has not reviewed it, other than to make the letter consistent with the new and unapproved new drugs section. 
 [ab10]Note: This section of the letter is not subject to OCC review, and OCC has not reviewed this section.