A Brooklyn, New York-based seller of a dietary supplement has agreed to settle Federal Trade Commission charges that it made unsubstantiated health benefits claims for "Alen," a powdered nutritional supplement comprised of wheat germ, wheat bran, soybean extract, and seaweed extract. Advertisements for "Alen" -- appearing primarily in Spanish language media in New York City in such publications as El Diario, a Spanish language newspaper and on a local Spanish language television station -- contained claims, among others, that "Alen" delays the aging process, eliminates anemia, controls addiction to excess fat and sweets, and helps diabetics naturally produce insulin. The FTC charged that the seller, Venegas Inc., and company owner and officer, Angel Venegas, did not possess competent and reliable substantiation for such claims. A proposed settlement of these charges would prohibit the company and its owner from making any representations about the health benefits, performance, or efficacy of any food, drug, or dietary supplement without possessing competent and reliable scientific evidence to support the claims.
This past June, officials from the Mexican government, the FTC, the Food and Drug Administration, and seven state Attorneys General announced "Campaña Alerta," an innovative and unprecedented effort to prevent deceptive advertisements directed at Spanish-speaking consumers. The joint law enforcement and public education campaign targets Spanish-language ads that deceptively market health care products and treatments, and informs consumers about how best to protect themselves against health fraud.
According to the FTC's complaint detailing the allegations in this case, print advertisements for "Alen" contained representations that "Alen:"
The FTC's complaint alleges that Venegas falsely represented that it possessed and relied upon a reasonable basis that substantiated these representations.
The proposed settlement to these charges, announced today for a public comment period before the Commission determines whether to make the settlement final and binding, would prohibit respondents Venegas Inc., and Angel Venegas, from making each of the specific representations alleged in the complaint for "Alen," or from making any representations as to the benefits, performance, or efficacy of any food, drug or dietary supplement, without possessing and relying upon competent and reliable scientific evidence to support the claims. The proposed settlement would permit the respondents to make representations specifically permitted in the labeling for any product by regulations promulgated by the Food and Drug Administration's (FDA) Nutrition Labeling and Education Act of 1990, and would permit the respondents to make any representation for any drug that is permitted by the FDA in the drug's labeling.
A summary of the proposed consent agreement will be published in the Federal Register shortly, and will be subject to a 60-day public comment period. Comments should be addressed to the FTC, Office of the Secretary, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580. This news release will also be issued in Spanish, and the FTC welcomes comments submitted in Spanish.
This matter was investigated by the FTC's New York Regional Office. The Commission vote to accept the proposed agreement for public comment was 4-0.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the consent agreement and an analysis of the agreement to assist the public in commenting are available on the Internet at the FTC's World Wide Web Site at: http://www.ftc.gov or by calling 202-326-3627. Copies of documents stemming from "Campaña Alerta" and other FTC documents are also available from the FTC's Public Reference Branch, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington D.C. 20580; 202-326-2222; TTY for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC's NewsPhone recording at 202-326-2710.
(FTC File No. 962 3218)