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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Entrenet Nutritionals, Inc. 5/8/13

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
13-PHI-16
 
May 8, 2013
Delivered Via United Parcel Service
 
Ms. Judy A. Hannan, President
Entrenet Nutritionals, Inc.
3 Nicholson Drive
Cuddy, PA 15031-9749
 
Dear Ms. Hannan:
 
This is to inform you that the U.S. Food and Drug Administration (FDA or we) inspected your facility, located at 3 Nicholson Drive, Cuddy, Pennsylvania, from October 12, 2012 to November 1, 2012. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 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 United States Code (U.S.C.) § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
 
Additionally, we have reviewed your product labels collected at the inspection and we have determined that certain of your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)] and/or the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved and Misbranded New Drugs
 
Your product labels for your products Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme 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 your product labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act:
 
Gone
  • “Gone is an all-natural herbal supplement known to reduce pain and inflammation…”
 
Cardio Rescue
  • “It may help…arterial debris to be dissolved quickly.”
  • “This product is designed to melt down deposits.”
 
Arthri-Attack
  • “MSM and Glucosamine…while helping the body protect against inflammation and damage.”
  • “…to help you rid your body of joint pain and discomfort.”
 
 
Complete Food Supreme
  • “…support for…people at high risk of cardiovascular disease and those with cardiovascular disease.”
 
Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme 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)]. A new drug may not be legally marketed in the United States 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, Cardio Rescue and Complete Food Supreme 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 products safely for their intended uses. Thus, the labels fail to bear adequate directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Dietary Supplement CGMP Violations
 
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)] 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 Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme did not contain disease claims in their labeling that cause the product to be an unapproved new drug under section 505(a) of the Act [21 U.S.C. § 355(a)], they would still be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. 
 
During the inspection, you stated that you (b)(4) your products. As a distributor that contracts with other manufacturers to (b)(4) 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 product conforms to established specifications and whether to approve and release the product 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 (b)(4) 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.
 
Your firm’s processes violate dietary supplement CGMP requirements in the following ways:
 
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 21 CFR 111.140(b)(1). Furthermore, your quality control personnel failed to ensure that your manufacturing, labeling, and holding operations ensure the quality of the dietary supplement, as required by 21 CFR 111.105. Specifically, you stated that you have not established quality control procedures for conducting a material review and making a disposition decision, and you do not conduct quality control operations to ensure the quality of the dietary supplement you receive from your contract manufacturers and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
 
We have reviewed your response dated November 15, 2012, and find it inadequate because you failed to provide any written procedures for your quality control operations or documentation of the quality control operations performed which we could evaluate for compliance with the regulations.
 
2.    Your quality control personnel failed to approve for release, or reject, packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h).
 
Specifically, you had no documentation of quality control operations related to approving for release, or rejecting, packaged and labeled Gone product for distribution. From March 20, 2012 through June 20, 2012, you distributed Gone, which was not identified with a lot number. You obtained this product from a firm that you identified as a “private labeler of Reumofan,” but you have no information about this firm or the product. You stated that the firm from whom you received the product received the product from a separate manufacturer, but you had no records about the identity of the manufacturer, how the manufacturing process was conducted, or any other records about the product. You failed to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. You had no information on which to conduct quality control operations to approve the packaged and labeled product for release, or reject the product, for distribution (see 21 CFR 111.103, 111.105, 111.127(h) and 111.140). 
 
We have reviewed your response dated November 15, 2012, and find it inadequate because you failed to outline the specific steps you will take to become compliant with the requirements related to quality control.
 
3.    You failed to establish and follow written procedures relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you confirmed to our investigator that you have no formal system in place to address product complaints. Once you have established the necessary written procedures, you must make and keep all related records, as required by 21 CFR 111.570.   Additionally, you failed to make and keep a complete written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2)(ii). Specifically, you were notified by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) on September 18, 2012 that an adverse event had been reported associated with your product, Gone. This adverse event reported on FDA’s MEDWATCH form described that the complainant experienced severe stomach discomfort. Your reply dated October 2, 2012 referenced a telephone call with a customer; however, there is no record of your investigation of this adverse event including documentation detailing this telephone conversation with the complainant or results of the investigation.
 
We have reviewed your response dated November 15, 2012, and find it inadequate because you failed to outline the specific steps you will take to become compliant with the regulation.
 
4.    You failed to make and keep written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1). Specifically, your firm does not have written standard operating procedures for storage and distribution of your dietary supplement products.
 
5.    You failed to establish and follow written procedures to fulfill the requirements of 21 CFR Part 111, Subpart N for handling returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures to ensure the proper disposition of returned dietary supplements. Additionally, you confirmed to our investigator that products have been returned to your facility but that there were no records available which document the final disposition of these returned dietary supplements, as required by 21 CFR 111.535(b)(2).   
 
Dietary Supplement Misbranding Violations
 
In addition, even if Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme did not contain claims that cause them to be unapproved new and/or misbranded drugs, they would still be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343], as are your Natural Ease Plus, Purifying Cleanse I, Purifying Cleanse II, Cardio Cleanse, Cardio Repair, Seven Flowers BP, Pro Plus Gold, Big Mo Momentum Grande, Harmony Plus, Immune Force and Powerzyme, in that the products do not comply with the food labeling requirements in 21 CFR Part 101, as follows:
 
1.    Your Natural Ease Plus, Purifying Cleanse I, Purifying Cleanse II, Gone, Cardio Cleanse, Cardio Repair, and Seven Flowers BP products are misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] in that the labels fail to identify the products using the term dietary supplement [21 CFR 101.3(g)].
 
2.    Your Purifying Cleanse I, Gone, Cardio Rescue, and Seven Flowers BP products are misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels fail to bear nutrition labeling in the form of a “Supplement Facts” label in accordance with 21 CFR 101.36. Nutrition information for a dietary supplement shall be presented with the title, “Supplement Facts,” and enclosed in a box by using hairlines in accordance with 21 CFR 101.36(e)(1) and (2). Furthermore, your Cardio Repair product is misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] and in accordance with 21 CFR 101.36(b)(2)(ii)(B) because the percent daily value for selenium was not provided on the label.
 
3.    Your Natural Ease Plus and Pro Plus Gold products are misbranded within the meaning of Section 403(u) of the Act [21 U.S.C. 343(u)] because the nutrition information of these labels lists the dietary ingredient Siberian Ginseng. 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.
 
4.    Your ArthriAttack, Big Mo Momentum Grande, Cardio Repair, Gone, Pro Plus Gold, and Purifying Cleanse I products are misbranded within the meaning of Section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] because the labels fail to identify the part of the plant from which the dietary ingredients are derived. For example, your Pro Plus Gold label does not list the parts of the plants from which all of your botanical dietary ingredients are derived in accordance with 21 CFR 101.4(h)(1),
 
5.    Your Harmony Plus, Immune Force, and Seven Flowers BP products are misbranded within the meaning of Section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the serving size is incorrect or is not present on the label. The terms serving or serving size for a dietary supplement are defined in 21 CFR 101.9(b) and 101.12, Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example, the label for Harmony Plus recommends 1 capsule before each meal, and therefore, the serving size should be 1 capsule.
 
6.    Your ArthriAttack, Purifying Cleanse I, Powerzyme, Seven Flowers BP, Radically Free, and Complete Food Supreme products are misbranded in accordance with Section 403(q)(1)(B) of the Act [21 U.S.C. 343(q)(1)(B)] because the number of servings per container is not listed in either the nutrition label or with the net quantity of contents within the meaning of 21 CFR 101.36(b)(ii).
 
7.    Your Big Mo Momentum Grande, Cardio Repair, Cardio Rescue, and Cardio Cleanse product are misbranded in accordance with Section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] because the name and/or place of business are not listed on the label within the meaning of 21 CFR 101.5.
 
8.    Your Cardio Repair and Cardio Rescue products are misbranded in accordance with Section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the net quantity of contents in terms of weight, measure, or numerical count is not listed on the principal display panel of the label within the meaning of 21 CFR 101.105.
 
9.    Your Big Mo Momentum Grande is misbranded in accordance with 403(y) of the Act [21 U.S.C. 343(y)] because the label lists an incorrect telephone number to report adverse events; your label must list the domestic address or domestic phone number through which the responsible person as described in section 761 may receive a report of a serious adverse event, and not FDA’s medwatch telephone number.
 
The above violations are not intended to be an all-inclusive list 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 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 FDA taking regulatory action without further notice, including, without limitation, injunction or seizure.
 
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.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter and to prevent their recurrence. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections.
 
Your written response should be sent to Richard C. Cherry, Compliance Officer at the address noted above. If you have any questions concerning this letter, please contact Compliance Officer Cherry at 215-717-3075 or by email at Richard.Cherry@fda.hhs.gov.
 
 
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District
 
cc:       
Tracy Belcastro, CEO and Co-owner
Entrenet Nutritionals, Inc.
3 Nicholson Drive
Cuddy, PA 15031-9749
 
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director