Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis 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 October 22, 2018.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write: “A & O Enterprises Inc” on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/aoenterprisesivbarsconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write “A & O Enterprises Inc; File No. 1723016” 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; or deliver your comment to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.
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FOR FURTHER INFORMATION CONTACT:
Thomas Carter (214-979-9372) or James Golder (214-979-9376), Southwest Region, Federal Trade Commission, 1999 Bryan Street, Suite 2150, Dallas, TX 75201.
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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 from the FTC Home Page (for September 20, 2018), on the World Wide Web, 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 October 22, 2018. Write “A & O Enterprises Inc; File No. 1723016” 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 public Commission website, at https://www.ftc.gov/policy/public-comments.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/Start Printed Page 50373aoenterprisesivbarsconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that website.
If you prefer to file your comment on paper, write “A & O Enterprises Inc; File No. 1723016” 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; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC website at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any 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 that your comment does not include any 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 public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC 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.
Analysis of Proposed Consent Order To Aid Public Comment
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from A & O Enterprises Inc, a corporation, doing business as iV Bars Incorporated and iV Bars, and Aaron K. Roberts, also known as Aaron Keith (“respondents”). The proposed consent order (“order”) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 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 respondents' advertising, promotion and sale of intravenous drip cocktails (“iV Cocktails”), including the Myers Cocktail, which contain a mixture of water, vitamins, minerals and amino acids. According to the FTC complaint, respondents made false or unsubstantiated representations that their iV Cocktails are effective treatments for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia and neurodegenerative disorders, and that their cocktails produce fast, lasting results, are safe for all ages and cause no side effects. The FTC also alleges that respondents falsely represented that their iV Cocktails are clinically or scientifically proven to effectively treat the enumerated diseases and produce fast, lasting results. The complaint alleges that respondents' actions constitute unfair or deceptive acts or practices and the making of false advertisements, in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.
The order is designed to prevent respondents from engaging in similar acts or practices in the future. It includes injunctive relief to address these alleged violations and to prohibit similar and related conduct.
- The order defines “covered product” to mean any intravenous therapy, including all of respondents' iV Cocktails, and any intramuscular injection.
- Part I of the order prohibits express or implied claims that any covered product: (1) Is an effective treatment for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia, or neurodegenerative disorders; (2) produces fast, lasting results; or (3) cures, mitigates, or treats any disease, unless the claim is supported by competent and reliable scientific evidence that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant area. It further requires that such substantiation include a randomized, double-blind, and placebo-controlled human clinical trial.
- Part II of the order prohibits express or implied health benefit, efficacy, safety, or side effects claims for any covered product, unless the representation is non-misleading, and, at the time the representation is made, proposed respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity to support the claim, based on standards generally accepted by experts in the area. It further provides that such substantiation must include a randomized, double-blind, and placebo-controlled human clinical trial, when experts generally require such human clinical testing to substantiate the representation.
- Part III of the order prohibits respondents, in connection with the advertising, promotion, offering for sale, or sale of any covered product, from misrepresenting, expressly or by implication, that they assembled physicians, biochemists, or physiologists to create, test or approve the products, or that they maintain a research facility, including an iV Bars Research Lab.
- Part IV of the order prohibits respondents, in connection with the Start Printed Page 50374advertising, promotion, offering for sale, or sale of any product or service, from making any misrepresentation about the existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research, or that any product or service is scientifically or clinically proven to produce any benefit.
- Part V of the order requires that respondents, with regard to any human clinical test or study upon which they rely to substantiate any claim covered by the order, must preserve all underlying data and documents generally accepted by experts in the field as relevant to an assessment of the test.
- Part VI of the order provides that nothing in the order prohibits respondents from making a representation for any drug that is approved in labeling for such drug under any tentative final or final monograph promulgated by the Food and Drug Administration, or under any new drug application approved by the FDA.
Parts VII through XI are reporting and compliance provisions. Part VII mandates that respondents acknowledge receipt of the order and, for 10 years, distribute the order to certain employees and agents and secure acknowledgments from recipients of the order. Part VIII requires that respondents submit compliance reports to the FTC one year after the order's issuance and submit additional reports when certain events occur. Part IX requires that, for 10 years, respondents create certain records and retain them for at least 5 years. Part X provides for the FTC's continued compliance monitoring of respondents' activity during the order's effective dates. Part XI is a provision “sunsetting” the order after 20 years, with certain exceptions.
The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or order, or to modify in any way the order's terms.
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By direction of the Commission.
Donald S. Clark,
[FR Doc. 2018-21749 Filed 10-4-18; 8:45 am]
BILLING CODE 6750-01-P