Analysis of Proposed Consent
The proposed consent order has been placed on the public record for thirty (30) days for reception 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 other appropriate action or make final the agreement's proposed order.
The Commission's complaint charges that proposed respondents failed to have a reasonable basis for claims they made about Dr. Harris' Original Snore Formula tablets' efficacy in (1) preventing sleep apnea in adult and child users of the product who would otherwise develop sleep apnea, (2) treating the "early stages" of sleep apnea, and (3) eliminating, preventing, or significantly reducing snoring. Proposed respondents are also charged with failing to disclose or failing to disclose adequately that persons who have symptoms of sleep apnea should consult a physician because sleep apnea is a potentially life-threatening condition. Proposed respondents are further charged with making false claims that scientific testing establishes that the product can eliminate, prevent, or significantly reduce snoring in 86% of users. The complaint also alleges that Snore Formula, Inc., and its named officers provided the means and instrumentalities to others to disseminate false or deceptive claims about the product. Finally, the complaint alleges that Dr. Dennis H. Harris, M.D., misrepresented, by acting as an expert endorser for the product, that he had exercised his represented expertise in snoring treatment, in the form of an examination or testing of the product at least as extensive as an expert in the field would normally conduct.
Part I of the consent order requires that proposed respondents possess competent and reliable scientific evidence to substantiate representations that Dr. Harris' Original Snore Formula tablets or any other food, drug, device, service, or dietary supplement prevents sleep apnea in adult or child users who would otherwise develop sleep apnea; treats sleep apnea; or eliminates, prevents, or reduces snoring. It further requires that Dennis H. Harris, M.D., posses and rely upon competent and reliable scientific evidence and an actual exercise of his represented expertise to substantiate representations he makes as an expert endorser.
Part II of the order requires that, for any product or service that has not been shown to be effective in the treatment of sleep apnea, proposed respondents must affirmatively disclose, whenever they represent that a product is effective in eliminating, preventing, or reducing snoring, a warning statement about sleep apnea and the need for consultation with a physician or a specialist in sleep medicine.
Part III of the order requires scientific substantiation for any future claim about the effect of any food, drug, device, service, or dietary supplement on any disease, or about the effect of any food, drug, device, service, or dietary supplement on the structure or function of the human body, or about any other health benefit, or the safety, of any covered product or service. It further requires that Dennis H. Harris, M.D., posses and rely upon competent and reliable scientific evidence and an actual exercise of his represented expertise to substantiate representations he makes as an expert endorser.
Part IV prohibits Snore Formula, Inc., and its named officers from providing to any person or entity "means and instrumentalities" that contain any claim about the benefits, performance, efficacy, or safety of any food, drug, device, service, or dietary supplement, 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 Dr. Harris' Original Snore Formula or any other food, drug, device, service, or dietary supplement covered under the order.
Part V prohibits false claims about scientific support for any product or service.
Part VI requires Snore Formula, Inc., and its named officers to disseminate a notice ("Attachment A") about the order to distributors who have purchased Dr. Harris' Original Snore Formula tablets from respondents or from one of respondents' other distributors on or after January 1, 2001. This notice indicates that Snore Formula, Inc., 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 Snore Formula, Inc. Part VII of the order requires dissemination of Attachment A to future distributors, and that Snore Formula, Inc., monitor their distributors, and terminate sales to distributors who make representations prohibited by the order.
The remainder of the proposed order contains standard requirements that proposed respondents maintain advertising and any materials relied upon as substantiation for any representation covered by substantiation requirements of the order; distribute copies of the order to certain company officials and employees; notify the Commission of any change in the corporation that may affect compliance under the order; notify the Commission of any change in employment by the individual proposed respondents, and file one or more reports detailing their compliance with the order. Part XIV of the proposed order is a provision whereby the order, absent certain circumstances, terminates twenty years from the date of issuance.
This proposed order, if issued in final form, will resolve the claims alleged in the complaint against the named respondents. It is not the Commission's intent that acceptance of this consent agreement and issuance of a final decision and order will release any claims against any unnamed persons or entities associated with the conduct described in the complaint.
The purpose of this analysis is to facilitate public comment on the proposed order, and is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.