by Dr. Mercola
This is why a case that was recently heard before U.S. District Court Judge Vanessa L. Bryant could turn out to be a landmark event, as she ruled that the “FDA went too far” in censoring health claims related to green tea and cancer.
FDA Wording Too Strong, “Effectively Negates” Qualified Health Claims
The U.S. Food and Drug Administration (FDA) allows food and supplement manufacturers to use a qualified health claim (QHC) when “there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition.”i
However, because the evidence is still emerging, the FDA requires “qualifying language” to be included with the claim “to indicate that the evidence supporting the claim is limited.” In the case of Fleminger, Inc., which sells green tea and filed a health claim petition in 2004 to highlight green tea’s anti-cancer properties, the FDA suggested that this disclaimer be added to the health claim:
“FDA concludes that it is highly unlikely that green tea reduces the risk” of breast cancer or prostate cancer.
Obviously, this essentially contradicts the health claim. So, in 2010 (after a petition to review the FDA’s disclaimer was denied), the FDA threatened to seize Fleminger’s products if they did not use the exact disclaimer above. Eventually the FDA sent a revised claim, which still negated the point of the health claim:
“Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.”
This is a major win for natural food and supplement producers alike, as the FDA is being required to revise the disclaimer so as not to negate the health claim being made. At this point, Fleminger took the case to court, where Judge Bryant ruled:
“The FDA’s language “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”
Why Can’t Foods Have Truthful Health Claims on Their Labels?
This is perhaps the underlying question: why must manufacturers petition the FDA to make truthful, science-based health claims in the first place and then have them subjected to disclaimers? This is a serious waste of tax dollars – not to mention an assault on your freedom of access to information (and for the manufacturers, on their freedom of speech).
The fact is, QHCs are currently the only way that companies can make truthful health claims about natural foods or supplements. However, they are not easy to come by (the FDA approved only 12 QHCs from 1999 to 2010). Under current FDA law, if a food or natural supplement makes a medical claim without a QHC, it’s automatically classified as a drug. The Alliance for Natural Health explains:
“Outside of QHCs, food and supplements are not allowed to speak of the specific health benefits of their products because the FDA takes the position that any such statement magically turns them into drugs. And, as drugs, they would have to go through exorbitantly expensive drug trials, a cost which the manufacturer could never recoup, since food and supplements are natural products and cannot be patented. Without a patent, anyone can sell them, so paying as much as a billion dollars for a drug trial is essentially money down the drain.”
Believe it or not, the FDA recently sent a warning letter to Diamond Food for making truthful, science-backed health claims about the omega-3 fats in walnuts. But because the research cited health claims that omega-3 fats in walnuts may prevent or protect against disease, the FDA said walnuts would be considered “new drugs” and as such would require a new drug application to become FDA-approved.
The FDA’s current position is that foods such as walnuts, cherries, broccoli, turmeric, green tea and the like should be subjected to the full FDA approval process. But obtaining a new drug application, as the FDA suggests, can cost billions of dollars. And let’s face it – small food and supplement producers cannot come close to affording that!
In related news, the U.S. Federal Trade Commission (FTC) also suffered a loss in its efforts to hold Garden of Life, the marketer of various dietary supplements, in contempt of a previous consent order. The FTC alleged that Garden of Life violated the order by making false and baseless claims about its vitamin C and omega-3 fat based products, but the court ruled that the FTC had failed to prove that any of the challenged claims violated the consent order. It’s a small win, but it could have major repercussions for other natural supplement makers who are being unjustly attacked by the FTC or another government agency.
Experts Challenge FDA over Approval for New Dose of Alzheimer’s Drug
It’s ironic that the FDA comes down so hard on truthful health claims about green tea or walnuts, but seemingly gives drug companies carte blanche when it comes to bringing new products to market. Case in point, with its patent set to expire in November 2010, Donepezil, a blockbuster Alzheimer’s drug with over $2 billion in annual sales in the United States, submitted a new dosage for FDA approval.
Four months before the patent expired, the FDA approved the new dose, even though 5 mg and 10 mg doses were already on the market (though set to go generic soon).
The approval also went against the advice of the FDA’s own medical and statistical reviewers and was contrary to scientific evidence, which showed the drug offered “no meaningful added benefit, just more harm.” In fact, a 2010 report published in the journal Seizure found that of the 71,471 adverse drug reactions classified as convulsive events reported by the World Health Organization between 1968-2006 donepezil alone accounted for 8.4% of them, indicating that the drug is not only unsafe but that an increased dosage scheme would likely only cause more seizures in exposed populations.ii
Adding insult to injury, advertisements for the drug made misleading claims that the higher dose led to important clinical benefits on measures of cognition and overall function, a statement professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice called “stunningly erroneous.” In a BMJ commentary titled “How the FDA Forgot the Evidence …,” the professors detail the more likely reason why the 23 mg dose was approved:
“What is the difference between 20 and 23? If you said three, you are off by millions—of dollars in sales, that is—at least from the perspective of Eisai, the manufacturer of donepezil (marketed as Aricept by Pfizer).
A little context helps make the math clearer. Donepezil, the biggest player in the lucrative market for Alzheimer’s disease treatments, was a blockbuster, with over $2B in annual sales in the United States alone. But the drug, first approved in 1996, had reached the end of the road: the patent expired in November 2010.
Investors call this “going over the cliff,” an anxious reference to plummeting sales as market share is lost to generic competitors. Necessity, however, is the mother of invention. Just four months before the expiry of the patent, the US Food and Drug Administration (FDA) approved a new dose for moderate to severe Alzheimer’s disease: donepezil 23 mg. Is 23 an odd number? Not really, when you consider that you cannot get to 23 mg using the 5 mg and 10 mg doses that were going generic. The “new” 23 mg product would be patent protected for three more years.”
Support HR 1364 for Free Speech About Science
As unbelievable as it sounds, current law makes it illegal for natural supplement and food producers to share accurate, science-based health information with you.
Congressmen Jason Chaffetz (R–UT) and Jared Polis (D–CO) have introduced the Free Speech about Science Act (HR 1364), a landmark legislation that would allow the flow of legitimate scientific and educational information. The new bill provides a limited and carefully targeted change to FDA regulations so that manufacturers and producers may reference legitimate, peer-reviewed scientific studies without converting a natural food or dietary supplement into an “unapproved drug.” According to Rep. Chaffetz’s website, the provisions of HR 1364 do the following:iii
- Allow dietary supplements and healthy foods to cite legitimate scientific research
- Provide a clear definition of the types of research that may be referenced by growers and manufacturers
- Ensure that referencing such research does not convert a food or dietary supplement into an “unapproved (and therefore illegal) new drug”
- Retain the authority of FDA and FTC to pursue any fraudulent and misleading statements
According to Rep. Chaffetz:iv
“It is important for individuals and families to take charge of their personal health by making the right decisions to get and stay healthy. This includes accessing information so that individuals can adjust habits, eat healthfully, and take appropriate dietary supplements to prevent and even treat health conditions.
The Free Speech About Science Act helps insure their access to legitimate scientific research to make the necessary decisions to improve their personal health and the health of their families.”
Rep. Polis adds:
“Today’s science has shown that vitamins and nutritional supplements can offer successful, natural alternatives to drugs. As we begin to reform our nation’s healthcare system, supplements are an innovative way to help reduce costs.
The Free Speech About Science Act is a common sense act that will make it easier for doctors and consumers to learn about the cheaper, healthier alternatives to costly medicines that food and nutritional supplements provide.”
As of April 2012, HR 1364 was assigned to a congressional committee, which will consider it before possibly sending it on to the House or Senate. The majority of bills never make it out of committee, so we need your help.
Please lend HR 1364 your support by signing on as a co-sponsor TODAY.
Use the Alliance for Natural Health’s HR 1364 page to send a letter to your representative in support of this bill. And forward or post this article to all of your friends and loved ones who care about their health and their right to full information so they can make an intelligent choice in their health care decisions. With your combined influence we can be a powerful force for much-needed change.
- i U.S. Food and Drug Administration September 2003
- ii Seizure risk associated with neuroactive drugs: data from the WHO adverse drug reactions database. Seizure. 2010 Mar;19(2):69-73. Epub 2009 Dec 24. PMID: 20036167
- iii Chaffetz and Polis Introduce the Free Speech About Science Act, Congressman Jason Chaffetz Website, April 5, 2011.
- iv Chaffetz and Polis Introduce the Free Speech About Science Act, Congressman Jason Chaffetz Website, April 5, 2011.
Read the Full Article Here: http://articles.mercola.com/sites/articles/archive/2012/05/05/fda-disclaimer-on-green-tea-revised.aspx