ChrisInMaryville's Blog

Source: http://articles.mercola.com

By Dr. Mercola

Did you know it’s currently illegal for a food or supplement producer to tell you about their products’ scientifically proven health benefits?

As unbelievable as it sounds, a person can be thrown in jail for telling you the walnuts they grow may slow down the growth of prostate tumors, or cherries ease symptoms of arthritis and gout, even though this is truthful, accurate and helpful information for a consumer to know.

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.

(more…)