Bhelliom Enterprises Corp 5/29/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
May 29, 2014
Casey D. McCarthy
Bhelliom Enterprises, Corp,
10260 Allegro Drive
Boca Raton, FL 33428
Dear Mr. McCarthy:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility, located at 10260 Allegro Drive, Boca Raton, FL 33428 from July 10, 2013 through July 29, 2013. During our inspection, we found that your firm distributes dietary supplements under your firm’s name, and that you have entered into agreements with contract manufacturers to manufacture these products. We also found that you label your Growth-Rx HGH Enhancer and Thermolene Body Sculptor dietary supplement products. 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 (CFR), 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 the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
In addition, we reviewed your product labels and websites at www.bhelliom.com; www.thermolene.com; and http://www.bhelliom.com/alcohol.html in May 2014.
You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov
Unapproved New Drugs
We reviewed your websites at the Internet addresses http://www.bhelliom.com, http://www.bhelliom.com/alcohol.html, and http://www.thermolene.com in May 2014, and we have determined that you take orders there for the products Thermolene Body Sculptor and Alcohol-X™ Hangover Remedy, which the websites promote 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 websites establish that the products are drugs because they are intended for use in the 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.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Alcohol-X™ Hangover Remedy
- “All in One Hangover Relief For BEER, WINE and LIQUOR!”
- “PREVENTS and CURES Hangovers”
- “Acetyls-X is scientifically formulated to not only prevent hangovers, but also to quickly relieve hangovers after they have set in.”
In addition, when scientific references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. Your website at www.thermolene.com provides the following citations for your Thermolene Body Sculptor product:
- Berlan M, Galitzky J, Riviere D, Foureau M, Tran M A, Flores R, Louvet J P, Houin G, Lafontan M. Plasma catecholamine levels and lipid mobilization induced by Yohimbine in obese and non-obese women. Int J Obes. 1991 May;15(5):305-15;
- Yoshida T, Sakane N, Umekawa T, Kondo M. Relationship between basal metabolic rate, thermogenic response to caffeine, and body weight loss following combined low calorie and exercise treatment in obese women. Int J Obes Relat Metab Disord, 1994. 18(5):345-50.
Your Thermolene Body Sculptor and Alcohol-X™ Hangover Remedy 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.
Furthermore, your Alcohol-X™ Hangover Remedy product is 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 this drug safely for its intended purpose. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its labeling fails to bear adequate directions for use.
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)].
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 Thermolene Body Sculptor and Alcohol-X™ Hangover Remedy dietary supplement products did not have therapeutic claims which make them unapproved new and misbranded drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
1. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you did not have written procedures for reviewing and investigating product complaints received. Additionally, you did not keep written records of product complaints related to good manufacturing practice received by your firm associated with your Mr. Energy 8-HR Energy pill, as required by 21 CFR 111.570(b)(2). Moreover, you informed our investigator that you did not review and investigate the product complaint you received from a women experiencing vomiting after taking your product, Mr. Energy 8-HR Energy Pill, on an unknown date, as required by 21 CFR 111.560(a).
Your product complaint procedures must specify that a qualified person review and investigate any product complaint that involves the possible failure of a dietary supplement to meet any of its specifications, or any other requirement of 21 CFR Part 111 (see 21 CFR 111.560(a)), quality control personnel review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow up action of any investigation performed (see 21 CFR 111.560(b), and the review and investigation of the product complaint must extend to all relevant batches and records (see 21 CFR 111.560(c)).
We have reviewed your response dated August 21, 2013, which states that you have now established written procedures for requirements to review and investigate product complaints. However, we find your response inadequate in that you have not established your firm’s own procedures to address product complaints associated with your products nor have you established procedures to investigate those complaints. You simply provided a written recitation of the requirements of 21 CFR 111.560 and 111.570, rather than establishing written procedures to fulfill these requirements.
2. You failed to establish and follow written procedures for the responsibility of 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). Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
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 your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products 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 FD&C 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 FD&C 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 enters into a contract 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.
You must also 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). You must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must ensure that your 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). 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)).
However, you informed our investigator that you do not have a designated quality control employee, do not have designated procedures describing their responsibilities, and have not established procedures for ensuring the quality of dietary supplements received from your contract manufacturer(s) to ensure the quality of the dietary supplements you distribute or that they are packaged and labeled according to the master manufacturing record of your contract manufacturer(s).
We have reviewed your response dated August 21, 2013, which includes “Procedures for Qualification of Contract Manufacturers” and states that additional written quality control procedures have been added to specifically require inspection of incoming contract manufactured dietary supplements and components for quality control. However, you did not provide FDA with any documentation of such written quality control procedures. Therefore, we cannot determine the adequacy of your proposed corrective action at this time.
3. You failed to establish specifications for your dietary supplement products, as required by 21 CFR 111.70. Specifically:
- You failed to establish specifications for dietary supplement labels (labeling specifications) as required by 21 CFR 111.70(d). Specifically, you failed to establish labeling specifications for your Growth RX HGH Enhancer dietary supplement product, Lot #2070576, and your Thermolene Body Sculptor dietary supplement product, Lot #111299.
- You failed to establish specifications to provide sufficient assurance that products you receive from a supplier, for packaging or labeling and distribution as dietary supplements, are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f).
- You failed to establish specifications for the labeling of the finished labeled dietary supplements, including specifications that ensure that you applied the specified label, as required by 21 CFR 111.70(g). Specifically, you have no written specifications with which to compare your finished products after you have applied labels to containers of your Growth RX HGH Enhancer and Thermolene Body Sculptor dietary supplement products.
We also note that once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73.
We have reviewed your response dated August 21, 2013. We find your response inadequate. Although you have created some verification procedures and specifications for receipt of some for your dietary supplements, you have not provided documentation showing that you have established labeling specifications for your dietary supplement products, as required by 21 CFR 111.70(d) and 21 CFR 111.70(g). Therefore, we are unable to verify the adequacy of your proposed corrective actions at this time.
4. You failed to make and keep records for your production and process control system requirements that apply to components, packaging, and labels, and for products that you receive for packaging or labeling as a dietary supplement, as required by 21 CFR 111.180. Specifically,
- You failed to make and keep receiving records for labels and for products that you receive for labeling as a dietary supplement, as required by 21 CFR 111.180(b)(2). You stated to our investigator that you did not make or keep records to document receiving labels and products you receive for labeling as a dietary supplement.
- You failed to make and keep written procedures for fulfilling the requirements that apply to products that you receive for labeling as a dietary supplement, as required by 21 CFR 111.180(b)(1). You stated to our investigator that you did not have written procedures for handling product received for labeling and distribution as a dietary supplement from your contract manufacturer. Prior to the close of the inspection, you provided newly created SOPs entitled, “Labels and Labeling Operations,” which appear to include written procedures for fulfilling the requirements that apply to products that you receive for labeling as a dietary supplement. We intend to verify the adequacy of your proposed corrective action at our next inspection.
We have reviewed your response dated August 21, 2013, in which you state that you are currently creating written procedures for handling label material received. Your response is inadequate because the documentation you included with your response, “Bhelliom Labeling Records,” does not adequately demonstrate that you are making and receiving records for labels and for products that you receive for labeling as a dietary supplement, as required by 21 CFR 111.180(b)(2).
5. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically,
- You failed to establish written procedures for handling returned dietary supplements returned to your facility from internet retail orders as well as returns from local retailers when the products do not sell as expected, have lower-than-expected efficacy, or have reached their expiration dates. Once you establish such written procedures, you must make and keep records of your written procedures, as required by 21 CFR 111.535(b)(1).
- You also failed to make and keep records of any material review and disposition on a returned dietary supplement, as required by 21 CFR 111.535(b)(2).
We have reviewed your response dated August 21, 2013, in which you state that new procedures were provided to our investigator. However, your response is inadequate because written procedures for returned dietary supplements were not provided to our investigator and you did not include them with your response for FDA to review the adequacy of your proposed corrective actions.
6. You failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. Specifically,
- You informed our investigator that you did not have written procedures for the holding and distributing operations for your dietary supplement products. Prior to the close of the inspection, you provided newly created SOPs entitled “Holding and Distributing Dietary Supplements.” However, these SOPs are inadequate because they are essentially a recitation of the regulations and do not address the specific conditions that are appropriate for your facility and that will protect against contamination and deterioration of your dietary supplement products.
Misbranded Dietary Supplements
During the inspection, our investigator also obtained photographs and copies of your contract manufacturer’s batch records for your Mr. Energy 8-HR Energy shots, Lot 0920G1, Best By: 9/2014, and manufactured on 9/20/2012. The label on the product reflects “yohimbine” is in the formulation, however a review of the manufacturer’s batch records reveals yohimbine was not added to the formulation. Based on our review of the label, your Mr. Energy 8-HR Energy shot is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading.
Further, your Mr Energy 8-HR™ Energy Capsule (4 ct.), Vigor-EX™ Capsule (2 ct.), Thermolene capsules (90 ct.) and Growth-Rx™ caplets (90 ct.) 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 comply with 21 CFR 101.36:
- The dietary ingredients listed as part of the proprietary blends XtenrG™ and Vigor-EX™ for your Mr Energy 8-HR™ Energy Capsule (4 ct.) and Vigor-EX™ Capsule (2 ct.), respectively, are not listed inside of the supplement facts panel in accordance with 21 CFR 101.36(c)(2). Instead, they are listed outside and adjacent to the panel.
- The dietary ingredients listed as part of the proprietary blends for Thermolene and Humatropin™ for your Thermolene capsules (90 ct.) and Growth-RX™ caplets (90 ct.), respectively, are not listed in accordance with 21 CFR 101.36(c). Instead, they are listed beneath your statement “*Daily Value Not Established.”
- Your Growth-Rx™ product (90 ct.) label is misbranded because it does not list dietary ingredients in the proper order in accordance with 21 CFR 101.36(b)(3)(i). Specifically, the label lists “Vitamin B3” after “Humanatropin.”
The violations cited in this letter are not meant to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 products are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and/or injunction.
Your Growth-Rx™ Dietary Supplement (90 Caplets) is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the correct serving size, as required by 21 CFR 101.36(b)(1). Specifically, the serving size for a dietary supplement must be determined in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b), Table 2. Under 21 CFR 101.9(b)(2), the serving size must be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion” (RACCs) that appear in part 101.12(b). The RACC for dietary supplements is the maximum amount recommended, as appropriate, on the label for consumption per eating occasion. The label for Growth-Rx™ Dietary Supplement states “Directions: Take one caplet 3 times daily. For maximum results, take 3 caplets 3 times a day.” Therefore, the serving size must be based on a RACC of 3 caplets. However, the label incorrectly declares the serving size as 1 caplet.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s cost for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct all of the violations described above and to prevent similar violations in the future. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Please send your written response to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions with regard to this letter, Mr. Morris can be reached at 407-475-4741 or Randall.Morris@fda.hhs.gov
Elizabeth W. Ormond
Acting Director, Florida District