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FDA Allows “Hilarious” Corn-Oil Health Claim
4/19/2007
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Makers of a food high in pro-inflammatory omega-6 fatty acids can put a scientifically unsupported heart-health claim on their corn oil

by Craig Weatherby


The U.S. Food and Drug Administration (FDA) just hit a new low in its obeisance to giant food companies.


FDA issued the decision late last month, in response to a petition from Associated British Foods: the $8-billion-per-year food giant that makes Mazola® corn oil, Karo® corn syrup and Argo® corn starch.


The ruling permits the following health claim on the labels of corn oil products, which includes the bizarre “…little scientific evidence…” qualifier underlined below, which echoed in the language of the agency’s decision:

  • “Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon (16 grams) of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil.
  • FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil.”

As the agency says in its ruling, “…due to the small number of subjects in the two intervention studies that showed a beneficial relationship and the fact that not all of the studies reported a benefit, FDA believes that the scientific evidence represents a very low level of comfort among qualified scientists that the claimed relationship is scientifically valid.”


Compared with saturated fats, omega-6 fatty acids are clearly beneficial for heart health.


However, the FDA’s decision to allow the new corn-oil claim seems irresponsible in light of four things:

  1. Mainstream medicine considers chronic, silent inflammation a key risk factor for heart disease.
  2. Corn oil is very high in omega-6 fatty acid, which, compared with omega-3s, are relatively pro-inflammatory.
  3. Americans consume five to 10 times more omega-6s than experts believe is optimal.
  4. Countries with higher ratios of omega-3s to omega-6s enjoy lower rates of depression and cardiovascular disease.

New qualified-claims category facilitates industry influence

Before 2002, the FDA only allowed “unqualified health claims” for foods, which require so-called “significant scientific agreement”: i.e., a general consensus among experts that the claim is valid and supported by all publicly available evidence.


The best known example of an unqualified claim is the one permitted on low-sodium foods: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”


This new label claim for corn oil is similar to the qualified claims that were previously allowed for olive oil and canola oil, for which the evidence was described as “limited and not conclusive,” instead of the weaker “very limited and preliminary” standard that the agency decided corn oil meets.


Because a qualified claim does not require “significant scientific agreement”, it invariably includes a disclaimer that describes the strength of the supporting evidence.


The FDA now issues permits for three levels of qualified health claims, which meet the varying levels of evidence:

  • Strongest Qualified Claim—“Although there is scientific evidence supporting the claim, the evidence is not conclusive.”
  • Medium-Level Qualified Claim—“Some scientific evidence suggests… However, FDA has determined that this evidence is limited and not conclusive.”
  • Weakest Qualified Claim—“Very limited and preliminary scientific research suggests…. FDA concludes that there is little scientific evidence supporting this claim.”

The FDA determined that the evidence backing the new corn oil claim met only the weakest claim standard: one so low as to invite bad decisions in response to political pressures from “big food.”


Last year, we heard Marion Nestleprofessor of nutrition at NYU and a widely respected advocate for public healthspeak about the nutritional sins of the food industry and its ability to bend public policy to its will.


Her comment to the Los Angeles Times regarding the new corn oil claim reflects the disdain with which anyone knowledgeable about nutrition and health should hold the agency’s decision: “It’s hilarious. They get funnier and funnier. This one is at the far end of hilarity” (Ravn K 2007).


Dr. Nestle also voiced a cautionary note in her LA Times interview: “There's a tendency to put the good parts in big print and the bad parts in small print,” because FDA sets no limits on how health claims must appear on labels or in ads.


Further, in a 2005 report the FDA acknowledged that few consumers read or understand the disclaimers attached to qualified health-benefit statements like the new corn oil claim. Consequently, the disclaimer attached to new corn oil claim won’t impede its misleading implications.


Compared with corn oil, olive oil enjoys much more evidence in favor of its ability to enhance heart health, but the FDA has only allowed olive oil labels to bear this slightly stronger label claim:


“Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of olive oil.”


And the olive oil claim approved by the FDA ignores the fact that extra virgin grade olive oil likely adds substantial additional benefits, thanks to its potent antioxidants.


Sadly, the FDA’s risible corn-oil-claim ruling supports the increasingly credible suspicion that corporate money and the political influence it buys plays a powerful role in the FDA’s decisions.



Sources

  • U.S. FDA. Qualified Health Claims: Letter of Enforcement Discretion - Corn Oil and Corn Oil-Containing Products and a Reduced Risk of Heart Disease (Docket No. 2006P-0243). Accessed online April 13, 2007 at http://www.cfsan.fda.gov/~dms/qhccorno.html
  • Ravn K. Corn oil's ‘qualified health claim’ raises eyebrows. Accessed online April 13, 2007 at http://www.latimes.com/features/health/la-he-cornoil16apr16,1,4611891.story?coll=la-headlines-health
  • U.S. FDA. Letter Responding to Health Claim Petition dated August 28, 2003: Monounsaturated Fatty Acids from Olive Oil and Coronary Heart Disease
  • (Docket No 2003Q-0559). Accessed online April 13, 2007 at http://www.cfsan.fda.gov/~dms/qhcolive.html

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