Former Metabolife CEO Michael Ellis has been sentenced to six months in jail for lying about Metabolife’s adverse event reports for its Metabolife 365 weight-loss product. Ellis, who pleaded guilty in November to one count of making false statements to the FDA in 1999 about Metabolife 356, was also ordered to pay a $20,000 fine.
Prosecutors argued Metabolife sent FDA letters stating the company “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.” However, the U.S Attorney’s office stated Metabolife’s records showed it had, indeed, received letters from consumers who experienced adverse events—including seizures, heart attacks, strokes, loss of consciousness and other serious illnesses—after taking Metabolife 365.
In 2002, Metabolife supplied FDA with 14,000 reports of ephedra-related events that the company had previously not disclosed to the agency. Consequently, Ellis and Metabolife were indicted on several counts of making false statements, and subsequent civil suits forced the company into Chapter 11 bankruptcy by 2005.
Ellis, who is no longer working in the dietary supplement industry, said he decided to plead guilty to move on with his life since the other lawsuits and litigations are already behind him.
SOURCE: NATURAL PRODUCT INSIDER
FDA issued a warning about dangerous sexual performance products marketed as dietary supplements and originating from China that contain undeclared drug ingredients. The agency warned consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products. The products are marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement, but they contain undeclared active ingredients of FDA-approved prescription ED drugs and are, thus, illegal without FDA approval.
FDA testing revealed Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, while Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. The agency reported neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.
FDA warned the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. The agency noted consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. It added ED is a common problem in men with these medical conditions, who may seek “natural” products because they have been advised against taking ED drugs. Additionally, FDA advised the safety, efficacy, and purity of these ingredients can not be validated because the manufacturing source of the active ingredients in these products is unknown.
A survey sponsored by GlaxoSmithKline suggests Hispanics and African Americans are more likely than whites to use unproven dietary supplements for weight loss.
The data was presented this month at the Annual Scientific Meeting of the North American Association for the Study of Obesity (NAASO).
The data reveals that Hispanics and African Americans are less likely to use commercial weight loss programs and more likely to exercise and use dietary supplements for weight loss compared to whites. The researchers have not publicized what constitutes ‘unproven’ dietary supplements.
The survey is significant in that it highlights that different ethnic groups have a predisposition towards different dietary supplement or functional food products. This is information likely to be of use to marketers looking to steer their products across a gamut of consumer demographics.
A recent major trend in the US has been for food marketers to target Hispanic consumers with ethnic and Latin flavours.
The initial survey was conducted between November 18, 2005 and January 10, 2006 at the Center for Survey Research & Analysis (CSRA) at the University of Connecticut.
A sample of 3,500 people completed the telephone interview for a response rate of 28 percent.
The researchers defined commercial weight loss programs as organized programs where clients attend regular meetings either in person or online, while they define dietary supplements for weight loss as herbs or plant extracts.
According to the National Institutes of Health, 66 percent of US adults are overweight or obese, with Hispanic and African Americans tending to have higher rates than whites.
The researchers highlighted factors that may have contributed to ethnic differences in reported use of supplements. These include: differences in preference, specific knowledge of weight loss options and supplement advertising targeted to ethnic minorities.
GlaxoSmithKline’s petition to the Food and Drug Administration (FDA) to ban dietary supplements from making weight loss claims, has opened a cupboard and only the deluded would deny the presence of one or two skeletons rattling around in there.
The petition seeks to reclassify weight loss health claims as disease claims and by most accounts is unlikely to succeed, but it has brought into focus issues industry has not managed to lay to bed.
Inadequate or incomplete scientific substantiation, question marks over efficacy, health claim exaggeration, formula contamination and mislabelling continue to dog the dietary supplements industry despite the best intentions of the 1994 Dietary Supplements Health Education Act (DSHEA) and Good Manufacturing Practice (GMP) regulations enacted last year.
It’s a situation that leaves industry open to the kind of attack GSK has mounted and drives the urgent need for it to get its house in order.
But the existence of rogue players hell bent on exploiting consumer weight management concerns only provides further ammunition to critics who caste the industry as being unregulated, unefficacious and unsafe.
“We’re never short of targets in the weight loss industry,” Michelle Rusk, from Federal Trade Commission’s division of advertising practices, said at Expo West in Anaheim in March. The FTC, along with the FDA, polices claims and labelling transgressions in the US.
The fact the FTC has busted more than 100 companies since 1990 for labelling and claim breaches and is in the midst of a crackdown, is an unhealthy statistic for industry and even unhealthier for its public image.
Yet at something like $4bn the market is hardly flagging - consumer interest in weight management is stronger than ever as obesity-related problems have increased.
Just as the vitamin E market was delivered a serious blow a few years ago after a meta-analysis questioned the nutrient’s efficacy, GSK’s action - successful or not - may already have dented sales in the sector.
GSK says weight loss dietary supplements don’t work and that obesity and the secondary diseases like diabetes, cancer and cardiovascular problems it is linked with are too serious a matter for dietary supplements to be making claims about without pre-market, pharma-style, disease claim approval.
Make no mistake - GSK’s 33-page petition is a very strong one. It is well-researched, well-written and premised on a public safety logic that has many advocates, some of whom are likely to be involved in FDA’s decision-making process that has about another five months to run.
It assesses a range of ingredients used in weight loss products - from bitter orange to hoodia to CLA (conjugated linoleic acid) - and concludes not one of them has been scientifically proven to manage weight.
“There is no credible scientific evidence that would support any type of a claim accompanying a weight loss supplement,” the petition states.
This then becomes an issue of semantics - as there are many studies that demonstrate botanical and other ingredients can benefit weight loss, but GSK says the trials are not rigorous enough, or numerous enough, and therefore discounts them.
Yet companies like DSM, Cognis and Sabinsa possess clinical data supporting their own branded weight management ingredients which may stand up to pharma scrutiny if the petition succeeded.
Commercial versus public interest
The fact GSK just last year launched “Alli” the only OTC weight loss drug that is a direct competitor to weight loss supplements has to be considered among its concern for the public’s health.
It is hard to deny the commercial benefit GSK would gain if FDA accepted its petition and re-classified weight loss claims as disease claims.
It’s offering, alli, has quickly become the third highest-selling weight management drug in the world, with sales of close to $150m so there is much at stake.
That aside, GSK’s action has thrown a light on industry that can yield positive results in the form of greater scientific verification.
When that is in place there will be less cracks in a predominantly honest industry for unscrupulous players to exist in. Until that happens, however, the bullets will continue to fly from the likes of GSK.
The FDA has seized more than 1 million dollars worth of illegal dietary supplements from LG Sciences (formerly "Legal Gear"). The products were being marketed to the bodybuilding world and were being sold online and in stores by the names: “Methyl 1-D,” “Methyl 1-D XL” and Formadrol Extreme XL. According to FDA officials the products that they were manufacturing contain food additives and other ingredients not approved for use in the United States.
The products "previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury," the FDA said.
The FDA is warning consumers of any of these products to consult their doctors as soon as possible. A lawyer for the company Ronald Berry, says that all of their products are legal and that the FDA just wants to insure that this is the case.
