Analysis of Proposed Consent
The Federal Trade Commission has accepted an agreement, subject to final approval, to a proposed consent order from Tru-Vantage International, L.L.C. ("TVI" or the "proposed respondent"). TVI is an infomercial producer. It also purchases media time, disseminates its infomercials, and fulfills the orders for products featured in the infomercials.
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.
This matter concerns advertising and promotional practices related to the sale of Snorenz, a purported anti-snoring product. Snorenz is a dietary supplement consisting of oils and vitamins that is sprayed on the back of the throat of persons who snore. The Commission's complaint charges that TVI failed to have a reasonable basis for claims, which were contained in infomercials it produced to promote Snorenz, about the product's efficacy in (1) reducing or eliminating snoring or the sounds of snoring, (2) reducing or eliminating snoring or the sounds of snoring for six to eight hours, and (3) treating the symptoms of sleep apnea. The complaint also alleges that TVI lacked a reasonable basis to substantiate representations that testimonials from consumers who used Snorenz represented the typical and ordinary experience of users of the product. TVI is also charged with making false claims that clinical proof establishes the efficacy of Snorenz. Further the complaint alleges that that the proposed respondent failed to disclose that the product is not intended to treat sleep apnea; that sleep apnea is a potentially life-threatening disorder characterized by loud snoring, frequent interruptions of sleep, and daytime tiredness; and that persons experiencing those symptoms should seek medical attention. Finally, the complaint alleges that TVI failed to disclose adequately that a material connection existed between a physician who appeared in the infomercials to endorse the product and the product's manufacturer and marketer, Med Gen, Inc. A separate consent settlement with Med Gen, Inc. (File No. 002-3211) is also being placed on the public record for comment.
Part I of the consent order requires that TVI possess competent and reliable scientific evidence to substantiate representations that Snorenz or any other food, drug, or dietary supplement reduces or eliminates snoring or the sound of snoring; reduces or eliminates snoring or the sound of snoring for any specified period of time through a single application; or eliminates, reduces or mitigates the symptoms of sleep apnea. Part II of the order requires that, for any product that has not been shown to be effective in the treatment of sleep apnea, TVI must affirmatively disclose, whenever it represents that a product is effective in reducing or eliminating snoring or the sounds of snoring, a warning statement about sleep apnea and the need for physician consultation. Part III of the order requires proposed respondent to substantiate any representation about the benefits, performance, efficacy, or safety of Snorenz or any other product, service or program. Part IV prohibits false claims about scientific support for any product, service, or program. Part V requires that, for any consumer endorsement or testimonial respondent uses to promote a product, service or program, it must either possess competent and reliable scientific evidence that the testimonial represents the typical or ordinary experience of users or make an affirmative disclosure that the testimonial is not typical. Part VI requires an affirmative disclosure of any material connection between TVI and any endorser or between an endorser and the marketer. Parts VII and VIII of the proposed order permit proposed respondent to make certain claims for drugs or dietary supplements, respectively, that are permitted in labeling under laws and/or regulations administered by the U.S. Food and Drug Administration.
The remainder of the proposed order contains standard requirements that respondent maintain advertising and any materials relied upon as substantiation for any representation covered by substantiation requirements under 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 obligations under the order; and file one or more reports detailing its compliance with the order. Part XIII 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 respondent. 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.