The US Food and Drug Administration (FDA) lost its bid to overturn a health claim for selenium-containing dietary supplements last Thursday in the United States District Court for the District of Columbia. District Court Judge Ellen Huvelle ruled unconstitutional the FDA’s censorship of selenium dietary supplement claims relating to the reduction of cancer risk. Jonathan Emord of Emord & Associates on behalf of the plaintiffs in the case (including lead plaintiff ANH-USA; Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship. The verdict, unless reversed on appeal, protects the First Amendment right of dietary supplement manufacturers to provide “qualified health claims”, which accurately communicate the state of science concerning dietary supplements. This is a remarkable seventh victory over the FDA by the Emord firm (six of which invalidated FDA health claim censorship).------------------------
The lawsuit was initiated last summer in response to the FDA’s 19th June 2009 decision to suppress selenium/cancer-risk reduction claims. Ten of the claims (all appealed by the plaintiffs) were held unconstitutionally censored. The plaintiffs expressed their belief that this violated their right to communicate truthful health information to the public. The judge found that the FDA had denied claims despite credible evidence supporting them and had thereby infringed on free speech.
Prior to this ruling the FDA required near conclusive scientific evidence for any nutrient claim. The judge ruled that so long as the claim is an accurate reflection of the state of science, the First Amendment protects it.
UPDATE: 8 July - Please read what one of the good health organizations has to say about US censorship of scientifically-backed health claims for selenium.
UPDATE: 21 June - Government Intervening in Vitamin Industry
Other reports on Centrum can be found here at Natural Health News using SEARCH.
By Lorraine Heller
“Multivitamins and minerals were the subject of one quarter of Adverse Event Reports (AERs) filed with FDA in the first six months of last year, but this does not mean that this product category is problematic, says the American Herbal Products Association (AHPA).
The trade group analyzed 598 AERs received by the US Food and Drug Administration (FDA) between January 1 and June 30 2008, which highlighted potential adverse health effects of dietary supplement products.
However, although 25 per cent of these were for mainstream multivitamins and minerals, the findings must not be misinterpreted as identifying this as the most dangerous class of products, said Michael McGuffin, director AHPA.
‘This is not a cause and effect reporting system, it’s an association system. So although a large part of the AERs are linked to multivitamins, this does not mean that they are dangerous. It simply reflects usage patterns, and the most used dietary supplements are multivitamins,’ McGuffin told NutraIngredients-USA.com.
The AER reports were obtained by AHPA via Freedom of Information (FOI) requests with FDA. AHPA revealed its analysis of these reports at the recent SupplySide East trade show in Secaucus, New Jersey.
A number of supplement brands or products were repeatedly flagged up in the AERs. The most common single product reports were for:
• Total Body Formula (93 reports)
• Bayer One a Day (all formulas) (81 reports)
• Centrum (all formulas) (25 reports)
• Flintstones Vitamins (all formulas) (24 reports)
• Mainstream calcium products (25 reports)
However, McGuffin again cautioned that this does not implicate these brands or products as being dangerous. It reflects the frequency of reporting by a select number of companies, which have put systematic reporting systems in place, he explained.
Out of the 600 AERs reviewed by AHPA, 44 percent were for combination products, 25 percent were for vitamins and minerals, 10 percent were for ‘other primary ingredients’ products, and 5 percent were for herbals.
The majority (almost 60 percent) of reports had been submitted by companies, while just under a third (30 percent) were submitted by consumers. Around 10 percent were sent in by health professionals.
The majority of cases (73 percent) were female consumers, and 54 percent of reports were for people aged between 50 and 79. Again, this reflects supplement usage, said McGuffin.”
Back in the 1980s there were daily publications of articles promoting the health benefit of selenium to protect men's prostate health. I've posted an ACS article from 2002 that shows this information below.
Several weeks ago I posted a discussion about a study that attacked selenium, showing mostly the ignorance of the people involved or interviewed regarding the effective form of selenium.
Generally inexpensive sodium selenite is the form used in synthetic products and it isn't always properly absorbed.
Now today Bayer is taking flack over its synthetic product, One-A-Day for Men. Well they should but not because of the concerns about synthetic vitamins, but for the fact that selenium - in the right form - is helpful for men's health and that of the prostate too.
Isn't it confusing? And do you really think medicine is progressing in providing prevention?
Group: Bayer ads mislead about prostate
Published: June 19, 2009 at 12:17 AM
A U.S. advocacy group notified Bayer Healthcare it will sue if the company continues to claim the selenium in its vitamins may reduce prostate cancer risk.
David Schardt, senior nutritionist at The Center for Science in the Public Interest in Washington, said advertisements and labels for One A Day Men's 50-plus Advantage and One A Day Men's Health Formula multivitamins claim "emerging research" suggests selenium may reduce the risk of prostate cancer.
However, leading prostate cancer researchers say there is scant evidence to support such a claim and have joined CSPI in urging the Federal Trade Commission to put an immediate stop to the claims, Schardt says.
"Bayer is exploiting men's fear of prostate cancer just to sell more pills," Schardt says in a statement. "The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo. Bayer is ripping people off when it suggests otherwise in these dishonest ads."
A seven-year study found last year that selenium does not prevent prostate cancer in healthy men, Schardt says.
"We are aware of CSPI's complaint and are in the process of reviewing their allegations, in the meantime, we stand behind all claims made in support of our products, including One A Day multivitamins," Bayer officials said in a statement to WebMD. "The claims made in support of selenium are based on an FDA-approved qualified health claim."
© 2009 United Press International, Inc. All Rights Reserved.
Study Links Selenium and Age to Prostate Cancer Risk
Mineral May Reduce Risk
Article date: 2002/01/02 from the American cancer Society
A new study suggests that the mineral selenium may be important in reducing prostate cancer risk as men age, according to a report in the Journal of Urology (Vol. 166, No. 6: 2034-2038).
The research suggests that the older men get, the less selenium they are likely to have in their blood. This may explain why a man's chance of getting prostate cancer goes up as he ages, since there may be a relationship between very low selenium levels and increased risk of prostate cancer.
“Our results suggest the possibility that selenium supplements may be especially beneficial for older men,” said lead author, James D. Brooks, MD, assistant professor of urology at Stanford University Medical Center in Palo Alto, Calif.
Brooks cautioned that too much selenium can be toxic. The Institute of Medicine, a government organization that determines the recommended dietary allowances (RDA) of vitamins and minerals, suggests a daily selenium intake of 55 micrograms (mcg) daily for men over the age of 14. Selenium is found in organ meats (liver), seafood and vegetables (which depend on the selenium content of the soil). The maximum intake daily of selenium should not exceed 400 mcg daily from all sources.
Lowest Selenium Levels Raised Prostate Cancer Risk
Most Americans get enough selenium, Brooks noted, but in some areas of the US there is not much selenium in the soil, so there may not be enough in drinking water or in food.
To study the relationship between selenium and prostate cancer, Brooks and colleagues compared the levels of selenium in the blood from 52 men taken before they developed prostate cancer, to the selenium levels in blood given by 96 men who did not later develop prostate cancer.
These men were all part of an ongoing study called the Baltimore Longitudinal Study of Aging. They were examined about every two years over a long period of time.
Men with the least amount of blood selenium were four to five times more likely to develop prostate cancer in the next few years than those with more, the researchers found.
“There may be a threshold level — a certain amount needed to lower risk — but beyond that, adding more selenium may not offer any more protection,” said Brooks.
Study First to Link Selenium Levels, Risk and Age
An American Cancer Society (ACS) expert on cancer and nutrition said the Stanford study confirms earlier studies that show selenium may reduce risk of prostate cancer by as much as 60%, and it adds new information as well.
“This is the first study to show that selenium levels may drop as age increases, which could help explain why men’s chances of developing prostate cancer go up as they get older,” said Carmen Rodriguez, MD, a senior epidemiologist in the ACS department of Epidemiology and Surveillance Research.
But Rodriguez cautioned that the study had so few men in it that it’s difficult to be sure that conclusions from it are meaningful.
And she expressed concern that blood samples weren’t necessarily collected at the same ages from men who developed prostate cancer later and from those who didn’t, making the comparison not as equal as a better matched one.
Study Raises Questions Likely to be Addressed by SELECT Trial
Rodriguez said men interested in those questions and in learning more about reducing their risk of prostate cancer with selenium and/or vitamin E may want to participate in the SELECT Trial trial, or wait for its outcome, she noted.
“In the meantime, all men can use the knowledge we already have to keep their prostate cancer risk as low as possible by learning the risk factors for prostate cancer, and how to actively reduce their chances of developing the disease,” noted Rodriguez.