The Federal Trade Commission has accepted an agreement, subject to final approval, to a proposed consent order from Max F. James (hereinafter “James” or “respondent”). James is a distributor of nutritional supplements for New Vision International, Inc., a multi-level marketing company. In a separate action, the Commission has also accepted a similar agreement involving New Vision International, Inc., an affiliated company, and two individuals.

The proposed consent order has been placed on the public record for sixty (60) days for the reception of comments by interested persons. Comments received during this period will become part of the public record. After sixty (60) days, the Commission will again review the agreement and any 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 has focused on James' participation in the creation and dissemination of advertisements for a regimen of nutritional supplements that he has called "God’s Recipe." The advertisements claimed that God’s Recipe could mitigate or cure the effects of Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder.

The proposed complaint alleges that James could not substantiate the following claims: (1) that God's Recipe can cure, prevent, treat or mitigate Attention Deficit Disorder or its symptoms; (2) that God's Recipe can cure, prevent, treat or mitigate Attention Deficit Hyperactivity Disorder or its symptoms; (3) that God's Recipe is an effective alternative treatment to the prescription drug Ritalin for Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder; and (4) that testimonials from consumers appearing in the advertisements for God's Recipe reflect the typical or ordinary experience of members of the public whose children have used the product.

Part I of the proposed consent order prohibits James, when advertising God's Recipe or any other food, drug or dietary supplement, from making claims (1) through (3), above, unless the claim is substantiated at the time it is made. Part II of the proposed order addresses claims made through endorsements or testimonials. Under Part II, respondent may make such representations if he possesses and relies upon competent and reliable evidence that substantiates the representations; or the respondent must disclose either what the generally expected results would be for users of the advertised products, or the limited applicability of the endorser's experience to what consumers may generally expect to achieve. The proposed order's treatment of testimonial claims is in accordance with the Commission's "Guides Concerning Use of Endorsements and Testimonials in Advertising," 16 C.F.R. 255.2 (a).

Part III of the proposed order prohibits James from making unsubstantiated claims about the safety of any food, drug or dietary supplement, or about the ability of such product to treat, cure, alleviate the symptoms of, prevent, or reduce the risk of developing any disease or disorder. Part IV of the proposed order contains language permitting James to make drug claims that have been approved by the FDA pursuant to either a new drug application or a tentative final or final standard. Part V states that James would be permitted to make claims that the FDA has approved pursuant to the Nutrition Labeling and Education Act of 1990.

Part VI of the proposed order requires James to retain, and make available to the Commission upon request, all advertisements and promotional materials containing any representation covered by the order, as well as any materials that he relied upon in disseminating the representation and any materials that contradict, qualify, or call into question the representation.

Part VII of the proposed order requires James to distribute the order to all current and future employees, agents and representatives having responsibilities under the order. Part VII would permit James to distribute a summary, in the form of a letter attached to the order as Appendix A, in lieu of the actual order.

The remainder of the proposed order contains standard requirements that James notify the Commission of changes in their employments status, and that he file one or more reports detailing his compliance with the order.

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.