The proposed consent order contains provisions designed to prevent MaxCell and its distributors from engaging in similar acts and practices in the future and to redress consumer injury by requiring MaxCell to make a monetary payment to the Commission.
Part I of the order bans claims that the ACI Test or any other substantially similar device provides a clinical gauge of an individual's overall healthiness or youthfulness. "Substantially similar device" is defined as any product that measures the ratio of 17-ketosteroids to creatinine in one urine sample.
Part II of the order requires that future claims that any test or device provides a clinical gauge of an individual's overall healthiness or youthfulness be true and substantiated by competent and reliable scientific evidence.
Part III of the order requires competent and reliable scientific evidence as substantiation for future claims that LSF or any other food, drug, device, service, or dietary supplement provides any of the specific health benefits challenged above as unsubstantiated. In addition, Part III. L requires scientific substantiation for any future claim about the effect of covered products or services on any disease, on the structure or function of the human body, or about any other health benefit, or the safety, of any covered product or service.
Part IV of the order prohibits MaxCell from providing to any person or entity "means and instrumentalities" that contain any claim about the effect of any product or service on any disease, or about the effect of any product or service on the structure or function of the human body, or about any other health benefit, or the safety, of any product or service, unless such claim is true and substantiated by competent and reliable scientific evidence. "Means and instrumentalities" is defined as any information, including but not necessarily limited to any advertising, labeling, or promotional materials, for use by distributors in their marketing or sale of the ACI test or LSF or any other product or service covered under the order.
Part V of the order prohibits MaxCell from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research.
Part VI of the order requires dissemination of a notice ("Attachment A") about the order to MaxCell's distributors who have purchased the ACI Test or LSF since January 1, 2000. This notice indicates that MaxCell has agreed to cease making challenged representations, and warns distributors that they may be terminated if they do not conform their representations to the requirements placed on MaxCell.
Part VII of the order requires dissemination of Attachment A to future distributors, and that MaxCell monitor their distributors, and terminate sales to distributors who make representations prohibited by the order.
Part VIII of the order permits FDA-approved drug claims and claims for food or dietary supplements authorized under the Nutrition Labeling and Education Act of 1990.
Part IX of the order requires that MaxCell make a payment of $150,000 to the Commission, which funds the FTC can forward to the U.S. Treasury as disgorgement or use for purposes of consumer redress.
Parts X, XI, XII, and XIV of the order require MaxCell to keep copies of relevant advertisements and materials substantiating claims made in the advertisements, to provide copies of the order to certain of its personnel, to notify the Commission of changes in corporate structure, and to file compliance reports with the Commission. Part XIII requires Stephen Cherniske to notify the Commission of his employment status, and Part XV provides that the order will terminate after twenty (20) years under certain circumstances.
The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.