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Health Research Laboratories, LLC; Analysis of Proposed Consent Order To Aid Public Comment
A Notice by the Federal Trade Commission on 03/23/2022
This document has been published in the Federal Register . Use the PDF linked in the document sidebar for the official electronic format.
- Document Details Published Content - Document Details Agency Federal Trade Commission Agency/Docket Number File No. 152 3021/Docket No. 9397 Document Citation 87 FR 16475 Document Number 2022-06079 Document Type Notice Pages 16475-16477 (3 pages) Publication Date 03/23/2022 Published Content - Document Details
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- Document Dates Published Content - Document Dates Comments Close 04/22/2022 Dates Text Comments must be received on or before April 22, 2022. Published Content - Document Dates
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Supplementary information:, analysis of proposed consent order to aid public comment.
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| Docket Title | Document ID | Comments | |
|---|---|---|---|
| FTC Seek Analysis To Aid Public Comment on Proposed Consent Agreement; Health Research Laboratories, LLC; Matter No. 152 3021 | 2 |
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FTC Seek Analysis To Aid Public Comment on Proposed Consent Agreement; Health Research Laboratories, LLC; Matter No. 152 3021
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Federal Trade Commission
- [File No. 152 3021/Docket No. 9397]
Federal Trade Commission.
Proposed consent agreement; request for comment.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis of Proposed Consent Order to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before April 22, 2022.
Interested parties may file comments online or on paper by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Please write “Health Research Laboratories, LLC; Docket No. 9397” on your comment, and file your comment ( print page 16476) online at https://www.regulations.gov by following the instructions on the web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580.
Elizabeth Averill (202-326-2993), Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f) , and FTC Rule 2.34, 16 CFR 2.34 , notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained at https://www.ftc.gov/news-events/commission-actions .
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before April 22, 2022. Write “Health Research Laboratories, LLC; Docket No. 9397” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.
Due to the COVID-19 pandemic and the agency's heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online through the https://www.regulations.gov website.
If you prefer to file your comment on paper, write “Health Research Laboratories, LLC; Docket No. 9397” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580. If possible, submit your paper comment to the Commission by overnight service.
Because your comment will be placed on the publicly accessible website at https://www.regulations.gov , you are solely responsible for making sure your comment does not include any sensitive or confidential information. In particular, your comment should not include sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f) , and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2) —including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the https://www.regulations.gov website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from that website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.
Visit the FTC website at http://www.ftc.gov to read this document and the news release describing the proposed settlement. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before April 22, 2022. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy .
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Health Research Laboratories, LLC; Whole Body Supplements, LLC; and their Managing Member and officer, Kramer Duhon (“Respondents”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.
This matter involves the Respondents' advertising for Black Garlic Botanicals, BG18, The Ultimate Heart Formula, and Neupathic. The complaint alleges Respondents violated Sections 5(a) and 12 of the FTC Act by disseminating false and unsubstantiated advertisements claiming that: (1) Black Garlic Botanicals, BG18, and The Ultimate Heart Formula will prevent, reduce the risk of, cure, mitigate, or treat cardiovascular disease, atherosclerosis, and/or hypertension; and (2) Neupathic will cure, treat, or mitigate diabetic neuropathy. Respondents Kramer Duhon and Health Research Laboratories are also parties to a previous federal court order in FTC and State of Maine v. Health Research Laboratories, LLC, et al., 2:17-cv-00467-JDL (D. Me. Jan. 16, 2018).
The proposed consent order includes injunctive relief that addresses these alleged violations and contains provisions designed to prevent Respondents from engaging in similar acts and practices in the future.
Part I would ban Respondents from advertising, marketing, promoting, or offering for sale any dietary supplements. Part II would ban Respondents from making any disease prevention, reduction of risk, cure, mitigation, or treatment claim when advertising, marketing, promoting, or offering for sale any product.
Part III prohibits Respondents from making any representation about the health benefits, safety, performance, or efficacy of any food or drug, unless the representation is non-misleading, and at the time such representation is made, Respondents possess and rely upon competent and reliable scientific evidence that substantiates that the representation is true. For purposes of ( print page 16477) this provision, “competent and reliable scientific evidence” means tests, analyses, research, or studies that: (1) Have been conducted and evaluated in an objective manner by experts in the relevant condition or function to which the representation relates; (2) are generally accepted by such experts to yield accurate and reliable results; and (3) are randomized, double-blind, and placebo-controlled human clinical testing of the product or of an essentially equivalent product, when experts would generally require such human clinical testing to substantiate that the representation is true. In addition, this provision requires that when such tests or studies are human clinical tests or studies, all underlying or supporting data and documents generally accepted by experts as relevant to an assessment of such testing must be available for inspection and production to the Commission.
Part IV prohibits Respondents from making misrepresentations: (1) That the performance or benefits of any food or drug are scientifically or clinically proven or otherwise established; or (2) about the existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research.
Part V requires Respondents to preserve supporting data and documents relevant to assessing human clinical tests that they rely on to support claims within the scope of Part III of the proposed order. Part VI requires Respondents to send notices to consumers who purchased Black Garlic Botanicals, BG18, The Ultimate Heart Formula, or Neupathic informing them about this matter and the Commission's order. Part VII prohibits Respondents and their officers, agents, and employees from disclosing, using, or receiving any benefit from customer information that Respondents obtained in connection with sales of Black Garlic Botanicals, BG18, The Ultimate Heart Formula, or Neupathic. Part VIII requires Respondents to cancel any subscription plan with a negative option feature related to Black Garlic Botanicals, BG18, The Ultimate Heart Formula, or Neupathic.
Parts IX through XII of the proposed order relate to compliance reporting and monitoring. Part IX is an order acknowledgment and distribution provision requiring Respondents to acknowledge the order, to provide the order to current and future owners, managers, business partners, certain employees, and to obtain an acknowledgement from each such person that they received a copy of the order. Part X requires Respondents to submit a compliance report one year after the order is entered, and to promptly notify the Commission of corporate changes that may affect compliance obligations. Part XI requires Respondents to maintain, and upon request make available, certain compliance-related records. Part XII requires Respondents to provide additional information or compliance reports, as requested.
Part XIII states that the proposed order will remain in effect for 20 years, with certain exceptions.
The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.
By direction of the Commission.
April J. Tabor,
[ FR Doc. 2022-06079 Filed 3-22-22; 8:45 am]
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FEDERAL TRADE COMMISSION v. HEALTH RESEARCH LABORATORIES, LLC
FEDERAL TRADE COMMISSION, et al., Plaintiffs, v. HEALTH RESEARCH LABORATORIES, LLC, et al., Defendants.
United States District Court, D. Maine. https://leagle.com/images/logo.png
August 12, 2020.
JON D. LEVY , Chief District Judge .
The Federal Trade Commission and the State of Maine (collectively, "Plaintiffs") bring this civil contempt proceeding against Health Research Laboratories, LLC, Kramer Duhon, and Whole Body Supplements, LLC (collectively, "Contempt Defendants"), for alleged violations of Section II.H of the Stipulated...
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IMAGES
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COMMENTS
November 13, 2020. File. Administrative Part 3 Complaint (46.02 MB) PRESS RELEASE: FTC Approves Administrative Complaint Against Supplement Marketer Health Research Laboratories, LLC. In March 2022, the FTC announced that two Texas-based companies and their owner are banned from advertising or selling dietary supplements, and from making claims ...
The business' principal lists an address of 433 Las Colinas Blvd E STE 1290, Irving, TX 75039. The actual physical location of Health Research Laboratories, LLC is currently unknown. BBB files ...
The action stems from an administrative complaint the FTC filed in November 2020 against Health Research Laboratories, LLC, Whole Body Supplements, LLC, and their owner and officer Kramer Duhon.
The FTC and the State of Maine's complaint against Health Research Laboratories and its principal, announced in November 2017, alleged that the defendants deceptively marketed two of their health products, BioTherapex and NeuroPlus. In November 2018, the FTC mailed 16,596 checks totaling more than $750,000 to consumers who bought the two deceptively marketed supplements.
The Federal Trade Commission has approved a Part 3 administrative complaint against dietary supplement marketer Health Research Laboratories, LLC (HRL), its owner and officer Kramer Duhon, and Whole Body Supplements, LLC (WBS) for making unsubstantiated claims that their supplements—The Ultimate Heart Formula (UHF), BG18, and Black Garlic Botanicals—prevent or treat cardiovascular and ...
Health Research Laboratories. 57 likes. A comprehensive suite of high quality nutritional, all natural men's and women's health supplements developed by researchers, nutritionists, doctors, and...
Health Research Laboratories, LLC, et al., 2:17-cv-00467-JDL (D. Me. Jan. 16, 2018). The proposed consent order includes injunctive relief that addresses these alleged violations and contains provisions designed to prevent Respondents from engaging in similar acts and practices in the future. Part I would ban Respondents from advertising ...
Who is Health Research Laboratories. Health Research Lab is a premiere distributor of high quality health supplements. Our business is focused on turning good ideas into innovative, ef fective supplements that make a real difference in healthful living. The company has always been committed to procure and deliver high caliber natural health products and herbal remedies available in the market ...
Health Research Lab is a premiere distributor of high quality health supplements. Our business is focused on turning good ideas into innovative, effective supplements. that make a real difference in healthful living. The company has always been committed to procure and deliver high caliber natural health products and herbal remedies available ...
Health Research Laboratories, LLC, In the Matter of (timeline item) - July 30, 2021. July 30, 2021. File. Commission Order Directing Parties to Submit Proposed Findings of Fact and Conclusions of Laws and Providing for Summary Decision Proceeding (804.19 KB) Return to top. Menu Secondary Menu.
ORDER. JON D. LEVY, Chief District Judge.. The Federal Trade Commission and the State of Maine (collectively, "Plaintiffs") bring this civil contempt proceeding against Health Research Laboratories, LLC, Kramer Duhon, and Whole Body Supplements, LLC (collectively, "Contempt Defendants"), for alleged violations of Section II.H of the Stipulated...
Health Research Lab is a premiere distributor of high quality health supplements. Our business is focused on turning good ideas into innovative, effective supplements that make a real difference in healthful living. ... Our R&D in Health Research Laboratories is integrated and project-driven. Our approach is therapy area-led with scientific ...
Founded in 2021 and headquartered in Pennsylvania, United Research Laboratories (URL) is focused on advancing underserved medical conditions in cardiovascular, oncology, and rare diseases. Our partnerships with industry and academia enable new product discovery and development to bring meaningful, differentiated medicines to patients. The URL ...
Health Research Laboratories, LLC, In the Matter of (timeline item) - December 1, 2021. December 1, 2021. File. Complaint Counsels Second Motion to Amend Complaint and Notice and Request for Remand (45.86 MB) Return to top. Menu Secondary Menu. Report Fraud; Get Consumer Alerts; Search the Legal Library;
Background: Obesity poses a significant global health challenge, necessitating effective prevention and treatment strategies. Exercise and diet are recognized as pivotal interventions in combating obesity. This study reviews the literature concerning the impact of exercise-induced cytokines, dietary factors, and inflammation on adipose tissue metabolism, shedding light on potential pathways ...
Health Research Laboratories, LLC, In the Matter of (timeline item) - September 13, 2021. September 13, 2021. File. Expedited Motion to Extend Complaint Counsel's Reply Date (745.09 KB) Return to top. Menu Secondary Menu. Report Fraud; Get Consumer Alerts; Search the Legal Library; Submit Public Comments;
4. "Corporate Defendant" means Health Research Laboratories, LLC, and its successors and assigns. 5. "Covered Product" means any Dietary Supplement, Food, or Drug, including BioTherapex and NeuroPlus. 6. "Defendants" means the Individual Defendant and the Corporate Defendant, individually, collectively, or in any combination. 7.
Health Research Laboratories, LLC, In the Matter of (timeline item) - April 21, 2021. April 21, 2021. File. Administrative Law Judge's Order Granting In Part and Denying In Part Respondents' Motion to Enter New Scheduling Order or, in the Alternative, to Transfer Case to the Commission (800.49 KB) Return to top.
Health Research Laboratories, LLC, In the Matter of (timeline item) - June 7, 2021. June 7, 2021. File. Respondents' Response To Motion To Extend Date For Complaint Counsel's Reply To Respondents' Response To Complaint Counsel's Statement Of Additional Material Facts And Opposition To Respondents' Motion To Strike (651.13 KB)
Health Research Laboratories, LLC, In the Matter of (timeline item) - March 31, 2021. March 31, 2021. File. Respondents' Expedited Motion to Enter New Scheduling Order Or, In The Alternative, Transfer Case to the Commission (728.04 KB) Return to top. Menu Secondary Menu. Report Fraud;
Health Research Laboratories, LLC (timeline item) - December 18, 2019. December 18, 2019. File. Plaintiff's Motion for an Order to Show Cause Why Health Research Laboratories, LLC, Whole Body Supplements, LLC, and Kramer Duhon Should Not Be Held in Contempt for Violating the Final Judgment and Order for Permanent Injunction (289.32 KB)