Yourlawyer.com (Ginko Biloba False Claims News) http://www.yourlawyer.com/topics/overview/Ginko_Biloba_False_Claims Sat, 21 Nov 2009 23:05:17 -0800 pixel-app en GAO Says FDA Should Better Regulate Dietary Supplements http://www.yourlawyer.com/articles/read/16167 Tue, 03 Mar 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16167 dietary supplements, the LA Times reported.

"Although FDA has taken some actions when foods contain unsafe dietary ingredients, certain factors may allow potentially unsafe products to reach consumers," the report states.  According to the LA Times, the report also indicated that, in the United States, vitamins, minerals, and herbs accounted for a $24.7 billion business in 2007.

The FDA has been the focus of much criticism in recent years with concerns over product liability and the agency’s ability to monitor and ensure safety, said the LA Times.  And, while some progress has been made, the GAO cited an extensive list of flaws that included, said the LA Times, that some herbal product manufacturers are not required to self-identify as dietary supplement companies and some companies are under no obligation to supply the FDA with details on products sold; manufacturers are not required to report mild or moderate reactions, only serious, adverse events; and the FDA not only maintains few oversight resources, but is unable to appropriately remove a product from the market.

The GAO also recommended, said the LA Times, that the U.S. Department of Health and Human Services (HHS) instruct the FDA commissioner to obtain added regulatory authority over supplement manufacturers and that such manufacturers produce a list of products and labels and report all adverse events. The FDA is also being urged to clarify when an ingredient is considered "new," as well as to clarify what is needed to document new ingredient safety.

Meanwhile, the enormous peanut butter salmonella scandal that has sickened over 600 and is linked to nine deaths, prompted President Barack Obama to order a “complete review” of the FDA, making the announcement in an interview on the Today Show with Matt Lauer last month.

The agency has long been criticized for a wide variety of issues, conflicts, and failures, with the recent, highly publicized peanut butter debacle causing outrage nationwide.  Said Obama, the peanut butter contamination that has hit nearly every state and Canada was just the most recent in an array of “instances over the last several years” in which “the FDA has not been able to catch some of these things as quickly as I expect them to catch,” reported Today in an earlier report.

Today noted that critics routinely pointed to the recent Bush administration as having “crippled” the FDA with eight years of budget cuts and a refusal to conduct an overhaul of the failing agency.  “At bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter,” said Obama in the Today Show interview, adding that, “we are going to make sure that we retool the FDA, that it’s operating in a highly professional fashion and, most importantly, that we prevent these things, as opposed to trying to catch them after they’ve already occurred.”



]]> More Turning to Herbs, Supplements, Despite Minimal Proof of Safety http://www.yourlawyer.com/articles/read/15861 Wed, 14 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15861 herbal and supplement medications is on the rise, especially in the midst of a rapidly sinking economy.  The Associated Press (AP) points out that consumers are delaying physician visits and turning to alternate forms of medication in an effort to keep costs down.

The AP notes that as the economy continues to falter, the herbal medicine industry is experiencing an upswing.  For example, Whole Foods spokesman Jeremiah C. McElwee told the AP that all of its stores are experiencing an increase in supplement and herbal product sales in recent weeks, adding that the trend is “noteworthy” in the midst of the economic downturn.  McElwee also pointed out, reported the AP, that even though the winter season usually brings an increase in such sales, even “more people are value shopping” because of the economy.

A couple of consumers interviewed by the AP said that with the high cost of medical care and the low return with insurance coverage, herbal alternatives are simply more cost effective, noting that old wives treatments, such as tea and honey, are significantly cheaper than even over-the-counter options.

In analyzing data, the AP reported that, nationwide, sales of vitamins and supplements climbed 10 percent in the recent three-month period, which includes a six percent increase in herbal supplements.  The AP report also noted nationwide increases in herbal and botanical supplement sales and some animal oil supplements.  Citing a government survey released last month, the AP reported that traditional medical costs were what prompted consumers to seek alternative solutions, quoting the report as stating,  “Nonvitamin, nonmineral natural products,” were taken by nearly 18 percent of Americans in 2007.  The report confirmed that cost was the driving factor, said the AP.

The Advocate reported that a recent federal survey—which involved 30,000 respondents—revealed that about 38 percent of U.S. adults 18 and older, and about 12 percent of U.S. children 17 and younger used some form of complementary and alternative medicine in 2007.  The survey was developed by the National Center for Complementary and Alternative Medicine.

A piece in this month’s issue of the Drug and Therapeutics Bulletin (DTB) concludes that no compelling evidence exists that some herbal remedies for menopausal symptoms either are or are not effective, said Science Daily, citing a release issued by the British Medical Journal (BMJ).  The BMJ said that between 30 and 70 percent of women will experience some menopausal symptoms for anywhere from four to 12 years and that herbal remedies such as black cohosh, red clover, Dong quai, evening primrose oil, ginseng, wild yam extract, chaste tree, hops, sage leaf, and kava kava—to name of few—are often recommended.  According to the DTB, there is little information on the efficacy, safety, and drug interactions of these herbs.

DTB also points out that herbal studies are often not well designed or populated and may not be conducted for sufficient time periods and because of the lack of oversight, herb potency may differ from batch to batch and manufacturer to manufacturer.  As an example of conflicting results, said the DTB, some clinical trials conducted on black cohosh found it to be extremely helpful in the treatment of menopausal symptoms while others found no significant efficacy.]]> Antioxidant Supplements Don't Cut Cancer Risk http://www.yourlawyer.com/articles/read/15770 Wed, 31 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15770 dietary supplements.

The nearly decade-long study—The Women’s Antioxidant Cardiovascular Study—involved 7,627 women taking beta carotene, vitamin C, or vitamin E in combination or individually over 9.4 years said Reuters.  The study revealed that, despite taking supplements, the women experienced no meaningful decrease in cancer risk over women who did not take supplements, reported Reuters, which noted that Dr. Jennifer Lin and colleagues conducted the clinical trial.

Medical News Today pointed out that the “randomized, double-blind, placebo-controlled” study also included researchers from Brigham and Women’s Hospital and that while this study did not reveal a link between vitamins—antioxidants—and a reduction in cancer incidence, a variety of observational studies have linked diets high in fruits and vegetables with cancer prevention. "Simply taking antioxidant supplements is insufficient to prevent cancer development," said study lead author Jennifer Lin, an assistant professor of medicine at Harvard Medical School, adding that eating fruits and vegetables rich in nutrients such as antioxidants, is still a good idea, according to Health Day News.  This is not the first time such a study has been unable to link supplements with cancer prevention, WebMD News noted.  Last month, similar results were derived from a study with male doctors taking either vitamin C or E, said WebMD News.

The 7,627 women in the recent study were cancer-free at the start of the research, said Medical News Today, and were part a larger 8,000-women group in which the women were randomly assigned to take either 500 mg of ascorbic acid—vitamin C—daily, a “natural source of vitamin E—600 IU of {alpha}-tocopherol—every other day, 50 mg of beta-carotene every other day, all three supplements, or a placebo.  The women all had or were at risk for cardiovascular disease, were over 40 years of age, and participated in the study from 1995 and 1996 until 2005—said Health Day News, which added that during the study, 624 women developed cancer and 176 died from cancer, leading the researchers to conclude that there was no "statistically significant" evidence that the supplements had any effect on a woman’s cancer risk.

Reuters reported that the risks were nearly the same in the vitamin C, the vitamin E, and the beta carotene group, with little difference in death risk in any one group; however, the risk was 28 percent higher in the vitamin C group, 13 percent lower in the vitamin E group, and 16 percent lower in the beta carotene group.  "We observed no overall associations of the three antioxidant supplements, taken singly or combined, with total cancer incidence or mortality.  Duration of supplementation also did not appear to alter the associations of these supplements with risk of cancer or mortality due to cancer," Lin and her colleagues wrote, said Reuters.

Also according to Reuters, Dr. Demetrius Albanes of the National Cancer Institute in Bethesda, Maryland discussed in an editorial on the study that two findings from the study "deserve additional mention."  It seems that vitamin E helped protect against colorectal cancer while beta carotene increased lung cancer risks, reported Reuters, which mirrors existing knowledge, noted Medical News Today.

]]> Harvard Prof's Ties to Supplement Maker Questioned http://www.yourlawyer.com/articles/read/15752 Mon, 29 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15752 Vivix Cellular Anti-Aging Tonic.

The ties between medical research have come under increasing scrutiny of late.  Just last week,  prominent researcher Charles Nemeroff agreed to step down as chair of Emory University's Department of Psychiatry and Behavioral Sciences, position he has held since 1991, following an internal investigation into his financial ties to drug makers.  The university also said it would be restricting Nemeroff’s research and  extracurricular activities.

According to The Wall street Journal, the school's investigation found that Nemeroff failed to report to Emory more than $800,000 he received from GlaxoSmithKline for more than 250 speaking engagements from Jan. 2000 to Jan. 2006.  According to the Atlanta Constitution-Journal, Emory’s investigation also found that Nemeroff received income from other drug makers, but Glaxo was by far his biggest patron.

In regards to Sinclair, the Journal reported that for six months, the Harvard researcher touted Vivix, which contains resveratrol, a compound found in red wine that may slow the aging process.  According to the report, at a conference last summer,  Sinclair told Shaklee salespeople that “over a year ago, we set out together to do this, to make a product that you could actually activate these genetic pathways that can slow down aging.”   

The Journal also reported that Sinclair appeared on  a Florida radio station with Shaklee's chief doctor to promote Vivix.  His picture also appeared on the website run by a Vivix sales rep.  That site claimed that Vivix could repair skin injuries, erase age spots, quell tremors and eliminate leg cramps, the Journal said.

According to the Journal, few makers of dietary supplements can claim such backing from a prominent medical researcher.

After the Journal report appeared, Sinclair left Shaklee's advisory board, and told the newspaper that the company had misused his name.  But the Journal says Shaklee denies that, and claims that Sinclair approved the use of his name in advertising.

Even with his resignation from Shaklee, Sinclair has not shed all of his industry ties.  According to The Wall Street Journal, Sinclair remains co-chief adviser to Sirtris Pharmaceuticals, now a division of Glaxo, which is also studying resveratrol for use as a drug. Dr. Sinclair received more than $8 million when Glaxo acquired Sirtris and the company pays him $297,000 a year as a consultant.

]]> Weight Loss Supplements Sold Online Could be Dangerous http://www.yourlawyer.com/articles/read/15724 Tue, 23 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15724
According to the FDA, these weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.  

The weight loss products covered by the FDA warning include:

  • Fatloss Slimming
  • 2 Day Diet
  • 3x Slimming Power
  • 5x Imelda Perfect Slimming
  • 3 Day Diet Japan Lingzhi
  • 24 Hours Diet
  • 7 Diet Day/Night Formula
  • 7 Day Herbal Slim
  • 8 Factor Diet
  • 999 Fitness Essence
  • Extrim Plus
  • GMP
  • Imelda Perfect Slim
  • Lida DaiDaihua
  • Miaozi Slim Capsules
  • Perfect Slim
  • Perfect Slim 5x
  • Phyto Shape
  • ProSlim Plus
  • Royal Slimming Formula Slim 3 in 1
  • Slim Express 360
  • Slimtech
  • Somotrim
  • Superslim
  • TripleSlim
  • Zhen de Shou
  • Venom Hyperdrive 3.0
An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.

The FDA said the health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

The FDA says it has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,”  Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a press release. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

]]> Airborne Settles False Claim Charges http://www.yourlawyer.com/articles/read/15693 Wed, 17 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15693
According to Reuters, Airborne had earlier  settled a class action suit for $23.5 million and also reached a $6.5 million settlement with the Federal Trade Commission (FTC).  But apparently, Airborne said these funds would be paid only if the larger settlement does not cover all consumer claims submitted by September 18.

"We're putting the dietary supplement industry on notice—snake oil sales pitches will no longer be given free reign," Connecticut Attorney General Richard Blumenthal said in a statement, quoted Reuters. "Our strong coalition of states will continue to investigate and pursue companies that make false claims about dietary supplements and other products," he said, added Reuters.

Airborne Founder and Chief Executive Victoria Knight-McDowell said in a statement that this settlement does not affect any of the company’s current products, "because it deals with language that had already been dropped from our advertising and labeling," Reuters quoted her as saying.  "Even though we believe the legal claims against Airborne were unjustified, we wanted to close the book on these legal and regulatory issues," Knight-McDowell added, said Reuters.  Blumenthal said that Airborne agreed to some prohibitions such as making claims over its products’ benefits, mandating where retailers place its products, and marketing any product that would involve a person ingesting in excess of certain amounts of International Units (IU) of Vitamin A daily, Reuters said.  News-Leader.com said that Airborne is no longer allowed to advertise that its products should be taken “at the first sign of a cold symptom,” as well as other claims in which Airborne implies its products can “can diagnose, mitigate, prevent, treat, or cure colds, coughs, the flu and upper respiratory infection or allergies.”

News-Leader.com pointed out that Airborne-Original is the top selling dietary supplement in its category and contains large amounts of Vitamin C and Vitamins A and E, zinc, and selenium.  The multi-state settlement involves all Airborne products, which includes Airborne-Original and any future products said News-Leader.com.

The settlement resolves the state and Washington D.C.’s attorneys generals’ allegations, said News-Leader.com, that Airborne made health-related claims in its “marketing, packaging, advertising, offering, and selling” of a variety of its products that were “not substantiated by reliable and competent scientific evidence when the claims were made”; that it “explicitly and implicitly claimed to sell a cold prevention remedy, a sore throat remedy, a germ fighter, and an allergy remedy without adequate substantiation”; and that it did not “adequately warn consumers about potential health risks to select populations,” said News-Leader.com.  This last allegation referred to excessive IUs of Vitaman A, specifically in pregnant women, noted News-Leader.com.

]]> FDA Announces Consent Decree with Supplement Maker http://www.yourlawyer.com/articles/read/15650 Wed, 10 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15650 unapproved claims that its products “cure, treat, mitigate, or prevent diseases.”  This is not the first time that Wilderness Family has been at the center of controversy with the FDA.  In 2005, the FDA issued an extensive warning letter to the company citing similar problems.  Wilderness Family is located in Silver Bay, Minnesota.

The FDA describes Wilderness Family as a manufacturer and distributor of conventional foods, dietary supplements, and various salves, which are all branded under the Wilderness Family name.  The Wilderness Family site touts a company location of pristine beauty, wilderness, and purity in which healthy, nutritious foods and supplements are manufactured.  According to the FDA, Wilderness Family marketed a variety of products via false claims on its labeling, its Website, and linked Websites.

Michael Chappell, the FDA's acting associate commissioner for regulatory affairs said that, “The FDA is acting to protect the American public from companies making unapproved disease treatment claims for their products.  Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.”  The FDA also stated in its press release that Wilderness Family has a history of promoting its products for the treatment of diseases, recently referring its customers to Websites that appeared to originate from other companies, but were actually controlled by Wilderness Family.  The sites hyped product benefits against diseases that included cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.

The consent decree mandates that Wilderness Family and its owners not make claims that its products can fight diseases unless those products receive FDA approval as new drugs or if such drugs satisfy FDA’s investigational new drug requirements (NDRs).  In response, Wilderness Family and its owners agreed to remove disease claims from its products’ labels and other labeling, its Websites, and references to other sites.  Wilderness Family and its owners agreed to hire an independent expert to review its product claims and certify to the FDA that it is not making any illegal claims.

The 2005 FDA letter to Wilderness Family followed the agency’s May 2005 investigation and cited the company’s manufacturing, distribution, and promotion of its products and a review of two of its Internet sites—www.wildernessfamilynaturals.com and www.regaininghealthnaturally.com—were conducted to determine if Wilderness Family was complying with the Federal Food, Drug, and Cosmetic Act (the Act), among other regulations.  The investigation revealed that, according to the FDA, its review of the company’s products and promotional claims showed “serious violations of the Act.”

The FDA notes that it can order Wilderness Family to stop manufacturing and distributing any product if Wilderness Family fails to comply with any portion of the consent decree, the Act, or FDA regulations, adding that defendants must pay $1,000 per violation per day if they fall into noncompliance.

]]> Ginko Biloba Lawyer False Claims http://www.yourlawyer.com/topics/overview/Ginko_Biloba_False_Claims Wed, 10 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/Ginko_Biloba_False_Claims Ginkgo Biloba False Claims Lawyers

Keywords: Ginko Biloba Lawyer False Claims

The lawyers at our firm are evaluating potential lawsuits against manufacturers and sellers of ginkgo biloba supplements.  Many companies that manufacture and market ginkgo biloba supplements make outrageous claims about their products' supposed ability to prevent or improve the symptoms of dementia and Alzheimer's disease.  Recent research has shown such claims to be false.

If you purchased ginkgo biloba supplements in the hopes of preventing or slowing the progression of Alzheimer's disease or dementia, you may be entitled to compensation.  We urge you to contact one of our ginkgo biloba false claims lawyers right away to protect your legal rights.

Ginkgo Biloba Claims
Ginkgo biloba is an herb that has been used medicinally for thousands of years.  Today, it is one of the top selling herbal supplements in the U.S.  According to the Nutrition Business Journal, Americans spent $107 million on ginkgo biloba products last year.  The marketers of ginkgo biloba supplements have been able to convince tens of thousands of consumers to buy these products by making misleading claims about their benefits. Our ginkgo biloba false claims lawyers are committed to holding these companies accountable for this deception.

Ginkgo biloba supplement manufacturers  make a variety of medical claims about their products.   Some claim the supplements promote blood circulation to the arms, legs and brain, thereby boosting overall physical activity levels.  Others claim that ginkgo biloba can ease the symptoms of depression and anxiety, premenstrual syndrome, sexual problems, and other ailments.  Ginkgo biloba has also been touted as a remedy for intermittent claudication (a blood vessel disorder that causes pain in the legs when walking), Lyme Disease, heart disease, stroke, high cholesterol, high blood pressure, allergies, and chronic fatigue syndrome.

One of the most common claims made about ginkgo biloba is that the supplements can improve memory.  Some manufacturers even go so far as to claim that their ginkgo biloba products can prevent or lessen dementia and Alzheimer's disease.  They make these claims because ginkgo biloba contains flavonoids, whose antioxidant properties have been shown to combat the chemical damage that accumulates in aging brain cells. 

Many small studies to evaluate ginkgo biloba's mental benefits have been done, but those studies have produced mixed results.  Many consumer advocates, including our ginkgo biloba false claims lawyers, are of the opinion that none of the existing scientific evidence justifies the outrageous claims many manufacturers make about these supplements.

JAMA Study on Ginkgo Biloba, Alzheimer's Disease and Dementia
In November 2008, the Journal of the American Medical Association (JAMA) published the results of a large study that found that ginkgo biloba supplements did nothing to prevent or delay dementia or Alzheimer's disease.  The study, which was funded by the National Institutes of Health, involved 3,069 men and women between the ages of 75 and 96.  The subjects were recruited from around the country.

A little over half of the participants - 1,545 -  took 240 milligrams a day of the ginkgo extract EGb 761. The other 1,524 participants took identical-looking placebos. All the pills were supplied by Schwabe Pharmaceuticals, a large supplement maker in Germany.

The subjects were given either the supplement or the placebo twice a day for an average of more than six years.  By the end of the study, however, there was no statistically significant difference in the rates of dementia or Alzheimer's between the two groups.  In fact, those who got ginkgo biloba were slightly more likely to be diagnosed with dementia and Alzheimer's than subjects in the placebo group.
 
According to the JAMA article, 277 people who took ginkgo, or 18%, were diagnosed with dementia, compared with 246, or 16%, in the placebo group. The ginkgo group also included 257 cases of Alzheimer's, versus 220 in the placebo group.  The study also found  no difference in the rate of strokes, heart attacks and other cardiovascular events between the two treatment groups.

The results of this study are further evidence that there is no scientific basis for many of the claims made by the manufacturers and sellers of ginkgo biloba supplements.  Still, many continue to deceive consumers about the medical benefits of these products.

The Food & Drug Administration (FDA) regulates dietary supplements, including ginkgo biloba products, under the Dietary Supplement Health and Education Act of 1994  (DSHEA). The makers of dietary supplements do not have to submit their products to the FDA for approval.   Under DSHEA,  the makers of dietary supplements must ensure that a  product is safe before it is marketed.  Manufacturers must also make sure that product label information is truthful and not misleading.

The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.  The agency monitors the  safety of these products through the voluntary reporting of side effects.  The FDA also has jurisdiction over  product information such as labeling claims, package inserts and accompanying literature.

The ginkgo biloba false claims lawyers at our firm believe that the labeling and advertising for many ginkgo biloba supplements include false and misleading information that violates DSHEA.  Consumers who purchased these products because of misleading claims about their benefits should be entitled to refunds.

Ginkgo Biloba False Claims Lawsuit
If you or someone you know purchased and used ginkgo biloba supplements because of claims that they could prevent or slow down the progression of Alzheimer's disease or dementia, you have valuable legal rights.  Please fill out our online form, or call 1-800 LAW INFO (1-800-529-4636) to  discuss your case with one of the ginkgo biloba false claims lawyers at our firm.]]>