Criminal Crackdown on Supplement Makers

November 21st, 2015 No comments »

This week the federal Department of Justice announced major criminal and civil actions against 100 makers of dietary supplements, including those for weight loss. According to DOJ, the actions resulted from a year-long effort, beginning in November 2014, to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide.  In each case, the department or one of its federal partners allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.

 

FDA Warns Public about Weight Loss Scams

January 5th, 2015 No comments »

The FDA has issued a timely reminder to consumers that many heavily marketed weight loss products are ineffective and possibly unsafe. The advice, while not new, is useful to remind consumers that weight loss frauds are rampant.

We tend to think of these scams as petty, fringe marketing programs. Not so. Watch this episode from the Today Show on NBC on January 5, 2015.  Easy to lose weight? No effort required? The Today segment carries forward a common fallacy: that cutting out X number of calories lost over 365 days will lead to amazing weight loss. No consideration of how many people can sustain such patterns? No consideration of the phenomenon known as Adaptive Thermogenesis. Oh yeah, permanent weight loss is so easy!

 

Was Dr.Oz truthful before the US Senate?

June 27th, 2014 No comments »

When Dr. Mehmet Oz testified before a Senate subcommittee on June 17, 2014, he was challenged by Senator Claire McCatskill on a study he had conducted on green coffee bean extract, “ Green Coffee Bean Extract “The Fat Burner That Works!” which aired on September 12, 2012.

Senator McCatskill questioned the quality of the science in this show saying it would “not pass scientific muster”. Dr. Oz replied that it would not meet what the Food and Drug Administration required to approve a drug. (No foolin!). Dr. Oz continued that he would not publish the study because it was not conducted under the appropriate IRB (Institutional Review Board) guidance. He explained that is was not under IRB guidance because “ the purpose was for me to get a thumbnail sketch: was this something worth talking about.” See clip at 2:50 minutes.

Dr. Oz Testifying Before US Senate

The show described in detail the hypothesis Dr. Oz was testing; the protocol was described by two members of his Medical Advisory Board; the use of placebo was described vis a vis the intervention group. The necessity of using a food journal was described as well as the inclusion and exclusion selection criteria. The terms “experiment,” “study,” “clinical trial” “placebo,” “intervention group,” “duration,” “food log (or journal),”study design,” “who (green coffee bean extract) is good for and who it is not right for,” “outcome,  and “results” were used 36 times. The recommendation from this study presented by Dr. Oz was that the extract  probably should not be used by pregnant women and children under 18. For all others, they could expect to lose twice as much weight as using a food journal alone, about a pound a week. Some thumbnail sketch!

It is interesting too that Dr. Oz said the study was not done “under appropriate IRB guidance.” The IRB process is intended to protect human subjects of medical treatments. The Columbia University College of Physicians and Surgeons where Dr. Oz is on the faculty has comprehensive IRB procedures, as required by New York State Law and Federal Law. It would appear that any research conducted on human subjects by a faculty member of the College of Physicians and Surgeons must be submitted for approval by the IRB. Under limited circumstances a study can receive an exemption from the IRB requirements but the exemption is  given by the IRB. Assuming that Dr. Oz received an exemption from the IRB, I’ve asked the director of the IRB program for an explanation of what the reasons for exemption were. They responded and said they are looking into it. Stay tuned.

 

Consumer Warning: Bee Pollen

June 20th, 2014 No comments »

The Food and Drug Administration (FDA) is warning consumers about using bee pollen, a supplement used for weight loss. According to the FDA, bee pollen products have been found to contain hidden and potentially dangerous ingredients that can be harmful for people with conditions such as irregular heartbeat, high blood pressure and bipolar disorders. In April, the FDA advised consumers to immediately stop taking  one specific product, Zi Xiu Tang Bee Pollen, because it contained at least one ingredient not listed on the product’s label. The company uses an elaborate marketing scheme to make consumers believe the product is not counterfeit.

 

Senators Scold Dr. Oz

June 17th, 2014 No comments »

Senators took Dr. Oz over the coals today for his promoting “miracle” weight loss products. NBS News reports that Missouri Senator Claire McCaskill, chair of the Senate Subcommittee on consumer protection asked, “So why, when you have this amazing megaphone…why would you cheapen your show by saying things like that?” She said Oz plays a role in perpetuating weight loss scams. Oz stated, “I concede to my colleagues (sic) at the FTC that I am making their job more difficult.” Oz said he thinks these products give people hope to keep trying to lose weight.

In fact, these fraudulent operators are selling false hope. They take money from people desperate to lose weight.  The products fails, of course, but because of the advertising messages,  overweight consumers believe that there is something wrong with them which make the product ineffective.

CBSNews reports that Dr. Oz said he did his own randomized clinical trial on green coffee bean extract. He described his clinical trial (probably not registered on ClinicalTrials.gov). He took 100 women in the studio audience; half took green tea extract and half had a placebo. After two weeks, the women on the supplement lost an average of two pounds while the placebo group lost an average of one pound.  The program aired in September 2012. Can’t wait to read the publication!

For those interested in actual factual information on weight loss scams, their prevalence and costs, check out the testimony by Mary Engle from the Federal Trade Commission at today’s hearing.

Dr. Oz’s Expertise on Weight Loss Scams

June 14th, 2014 No comments »

Ted Kyle’s blog has an excellent piece on the promotion of phony obesity treatments by Dr. Oz who is testify next week in the US Senate on the subject. Hey, why not ask an expert? Oz has promoted over a dozen.

Michael Specter did an excellent piece on the harm Dr. Oz is doing in an article in The New Yorker last year. Dr. Oz’s phony approach to obesity included extensive coverage of “The Dukan Diet” book by French doctor Pierre Dukan. Oz provided extensive coverage of the controversial book as well as taking the opportunity to promote his own.  I debunked Dukan diet here in 2011. (Really, it wasn’t hard.) Dukan was censured by the French medical board and ‘voluntarily’ took himself off the physician registry.

FTC Busts Weight Loss Scams

January 8th, 2014 No comments »

Just in time for those New Year’s resolutions to lose weight, the Federal Trade Commission (FTC) has lowered the boom on four weight loss companies for deceptive advertising and returning over $26 million to consumers.

“Operation Failed Resolution” is the latest in a long line of FTC enforcement efforts against the weight loss industry. The latest action targeted Sensa for a dietary supplement which, they claimed, when sprinkled on food would cause weight loss; L’Occitane which claimed that a skin cream would slim down users; HCG Diet Direct which marketed an unproved human hormone as a weight loss treatment; and LeanSpa LLC, which deceptively promoted acai berry and ‘colon cleanse’ for weight loss.

In addition to its enforcement work the FTC has a number of resources, including “Weighing the Claims in Diet Ads,” and “FTC to advertisers: 7 New Year’s resolutions.”

Likewise, the Better Business Bureau has “Gut Check: A Reference Guide for Media Spotting False Weight Loss Claims.

 

Consumer Alert – HCG hormone

December 6th, 2011 No comments »

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters on HCG “homeopathic” products sold over-the-counter for weight loss.  HCG or human chorionic gonadotropin is a hormone produced by the human placenta and found in the urine of pregnant women. It is approved as an injectable prescription drug for female infertility, among other conditions.

The letter warns companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims. There is no evidence, according to the agencies, that HCG improves weight loss beyond the recommended low calorie diet. For the press release, see Press Announcements > FDA, FTC act to remove “homeopathic” HCG weight loss products from the market