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The Food and Drug Administration has filed a complaint seeking a permanent injunction against James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, to stop the company’s distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
The complaint was filed by the U.S. Department of Justice in the U.S. District Court for the District of Oregon, Portland Division.
The Federal Trade Commission has announced two proposed settlements that will conclude their sweep against online marketers that allegedly used fake news sites to promote weight-loss products.
The two settlements, one with Beony International and owner Mario Milanovic and one with Beony International employee Cody Adams, each impose a $13 million judgment. However, that will be suspended when the defendants pay more $1.6 million and sell a 2008 Porsche. However, if the financial information the defendants provided is later determined to have been false, the full amount of the judgments will be imposed.
The Federal Trade Commission has upheld an Administrative Law Judge’s May 2012 decision that the marketers of POM Wonderful Pomegranate Juice and POMx supplements deceptively advertised their products as being able to would treat, prevent, or reduce the risk of heart disease, prostate cancer and other conditions.
PUH, which markets products under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, and its president, Stephen J. Poindexter, have entered into a consent decree of permanent injunction sought by the Food and Drug Administration for allegedly distributing unapproved new drugs and adulterated dietary supplements.
The Coleadium, Inc. affiliate network, also known as “Ads4Dough,” and its owner will pay $1 million to settle a Federal Trade Commission complaint that they used fake news sites to make deceptive claims to promote acai berry supplements and “colon cleansers” as weight-loss products. In addition, the FTC charged that they used “free trial” offers to trick consumers into signing up for additional shipments that were billed monthly.
The products included the acai berry supplements AcaiOptimum, AcaiBurn-Force Max, Acai Tropic, Acai Fit, and Acai Elite Blast; as well as colon cleansers Natura Cleanse, Smart Colon Flush, Advanced Colon Max, and Colo Flush.
The FTC’s complaint alleges that Coleadium and its owner, Jason Akatiff, acted as intermediaries between online merchants selling the products and affiliate marketers who used fake news Web sites to promote them and funnel consumers to the merchants’ sites. The complaint alleges that through their affiliates, the company and its owner:
- made false or unsupported claims that use of the acai and colon cleanser products would cause rapid and substantial weight loss;
- falsely represented that the stories on the fake news sites were objective news reports written by real reporters who conducted independent tests of the products, and that the comments following were those of independent consumers;
- failed to adequately disclose that the content on the fake news sites was authored by affiliate marketers who, along with the defendants, received payments from the merchants; and
- failed to adequately disclose that consumers who sign up to receive a trial supply of the advertised products but who do not return the products and cancel quickly will be charged for the products, and will be shipped more products and billed on a recurring basis.
In addition to the $1 million payment, the settlement requires Coleadium and Akatiff to monitor the affiliate marketers in their network to ensure that their statements are truthful and in compliance with federal advertising law. In addition, they are barred from making any material deceptive representations, including deceptive claims about weight loss and health, and about relevant studies, tests and research.
They also are barred from failing to disclose any material connection between themselves or others marketing or selling products, and the endorsers of the products; that the content of a “news” website or other publication was not written by an objective reporter but is an advertisement placed for payment; and that consumers may be subject to recurring charges when they sign up for trial supplies of the products.
An administrative law judge has upheld the FTC’s complaint and ruled that POM Wonderful LLC, its sister corporation Roll Global LLC, and principals Stewart Resnick, Lynda Resnick, and Matthew Tupper made deceptive claims in some advertisements that their POM Wonderful 100% Pomegranate Juice and POMx supplements (POM products) would treat, prevent, or reduce the risk of heart disease, prostate cancer and other conditions.
Chief Administrative Law Judge D. Michael Chappell’s initial decision would bar the POM respondents from making any representation about the health benefis of POM products or any other food, drug or dietary supplement unless the representation is not misleading and POM has scientific evidence that substantiates the claims.
The FTC sought to have POM respondents obtain FDA pre-approval before making any representations that any POM product is effective in the “diagnosis, cure, mitigation, treatment, or prevention of any disease.” Judge Chappell ruled that this requirement “would constitute unnecessary overreaching.”
The FDA and FTC have issued warning letters to companies marketing over-the-counter products containing human chorionic gonadotropin (HCG) hormone that are labeled “homeopathic” remedies for weight loss.
The two agencies say the joint action is the first step in keeping these products from being marketed online and in retail outlets.
HCG is FDA-approved as a prescription drug for the treatment of some cases of female infertility and other medical conditions, but is not approved for weight loss. The letters warn the companies that they are not only in violation of federal law by selling unapproved drugs, but that they are making unsupported weight loss claims.
The labeling for the “homeopathic” HCG products states that they should be taken in conjunction with a very low calorie diet. According to the FTC, the weight loss claims are deceptive since there is no substantial scientific evidence that HCG increases weight loss beyond that resulting from the calorie-restricted diet. In addition, the FDA says that people on very low calorie diets may be at risk for a number of harmful side effects and should only use such diets under medical supervision.
According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
U.S. Marshals at the request of the FDA have seized raw materials from Infinity Marketing Group, Inc. containing ephedrine alkaloids, ingredients banned by FDA since 2004 for use in dietary supplements.
The seized materials, more than 4,000 pounds of ephedrine alkaloid-containing raw material – Cissus quadrangularis and Cassia angustifolia extracts – were valued at $70,000.
Ephedrine alkaloids are adrenaline-like stimulants that are potentially dangerous effects to the heart. Before 2004, ephedrine alkaloids had been used extensively in dietary supplements promoted for aiding weight control and boosting sports performance and energy. However, available data showed little evidence of ephedrine’s effectiveness. There could be a modest, short-term weight loss, but that was without any clear health benefit. Yet the alkaloid raised blood pressure and otherwise stressed the circulatory system, effects tied to heart attack, stroke and death.
On the Wednesday before Thanksgiving, the FDA gave the owners of ATF Fitness Products, Inc. (ATF) and Manufacturing ATF Dedicated Excellence, Inc. (MADE) little to be thankful for. On that day, the Justice Department, on behalf of the FDA, filed legal action against the Oakmont, Pennsylvania companies seeking a permanent injunction that would stop them from manufacturing and distributing over 400 different dietary supplement products.
The action was based on alleged violations by ATF and MADE of the current Good Manufacturing Practice (cGMP) regulations for the manufacture of dietary supplements. According to the Complaint filed by the Justice Department, ATF is the sole distributor of dietary supplement products manufactured by MADE. Also named in the complaint is James G. Vercelotti, the owner and operator of both entities.
Under the cGMPs for dietary supplements (found at 21 C.F.R. § 111), dietary supplements must be manufactured according to processes that incorporate controls in the design and production process to assure a quality finished product. The purpose of the cGMPs for dietary supplements is to ensure quality and safety. According to the Complaint, ATF and MADE failed to adhere to the cGMPs in the manufacture of over 400 dietary supplement products. The Complaint alleges a number of deviations from the cGMPs at pages 3 through 5 of the Complaint. You can access the Complaint here.
In addition to the alleged deviations from the cGMPs, the Complaint alleges that the defendants misbranded their dietary supplement products by substituting ingredients for those listed on the product labels. Finally, the Complaint alleges that the defendants failed to submit Serious Adverse Event reports to the FDA as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (21 U.S.C. §§ 379aa – 379aa-1). As an example of this failure, the Complaint alleges that the defendants received a report of a serious adverse event from a consumer who claimed that one of their products caused a high blood pressure spike requiring hospitalization and subsequently caused a mild heart attack. The defendants failed to submit a report of this event to the FDA as required by the Act.
According to the press release issued by the FDA, this is the first time that the agency has sought a permanent injunction against a dietary supplement manufacturer of this size.
The FTC’s charges against three people and two companies charged with deceptive advertising of hoodia as a weight loss has resulted in a settlement where one defendant is banned from making any weight-loss claims related to foods, drugs, or dietary supplements and must turn over a vacation home and other assets to the FTC; another is banned from the dietary supplement business altogether; and all defendants are barred from making any more deceptive claims.
The FTC’s 2009 complaint alleged that the defendants made false and deceptive claims about hoodia and its effectiveness as a treatment for obesity, and falsely claimed that their ingredient was hoodia when it was not. The complaint also alleged that they falsely and deceptively claimed their product was, among other things, scientifically proven to suppress appetite, resulting in weight loss and was clinically proven to reduce caloric intake by 1,000 to 2,000 calories per day.
- David J. Romeo, and two companies he controlled, Nutraceuticals International LLC and Stella Labs LLC, are banned from making any weight-loss claims while marketing foods, drugs, and dietary supplements. The settlement imposes a $22.5 million judgment against Romeo and the two companies, which will be suspended when Romeo forfeits his vacation home in Vermont, and assigns to the FTC the right to collect on $635,000 in business loans owed to him. If it is later determined that the financial information Romeo gave the FTC was false, the full amount of the judgment will become due.
- Nutraceuticals International principal Craig Payton is banned from marketing any foods, drugs, or dietary supplements.
- Nutraceuticals International marketing executive Deborah B. Vickery is required to pay a $4 million judgment, which has been suspended due to her inability to pay..
- All five defendants are prohibited from making any false or unsupported claims about foods, drugs, or dietary supplements, and from helping others to make these claims. They also are barred from misrepresenting the results of any scientific study.