Can the FDA Be Trusted?

In the case of food safety it comes down to one thing - whether or not the FDA says something is ok, or "acceptable". But how do we know they're working with enough knowledge? They're only as good as their information and they themselves have admitted to flawed studies. Not only that but they compare data from a wide variety of sources, including studies funded by companies with an interest in keeping their products approved.

I started out tonight writing an article on the use of plastics in every day life - the waste, environmental, and possible health impacts. I began doing my research into the area that's most controversial and alarming because it could directly affect all of us - the affect of various components of plastics leaching into our food and water. There are many that have been found to disperse through one method or another. Antimony and dioxin are two of them. I've found many good sources both pro and against the claims that this is a threat to your health. But that's the problem - pick any topic, especially one of any economic importance - and you'll have dozens of people on either side willing to give their expert opinion. How does the average consumer decide which expert is really expert enough? How do you know that first MIT guy to give his findings did his work any more thoroughly than the last guy?

I found my tentative answers on plastic and food safety but the search resurrected a larger and more pressing dilemma - is the FDA realiable? With all the conflicting evidence, how do we know they haven't made mistakes? I want to close my eyes and say, "Yes it's reliable and trustworthy. It is a government agency appointed with keeping our food supply safe. No one in government would put anything before the safety of the American people." But then I remember I live in , where a horse show commissioner became head of a castrated FEMA.

It's also where an embattled FDA chief nominee, Lester Crawford, resigned after just two months on the job in September 2005. The reason? The Department of Justice charged him with violating conflict of interest laws and lying about owning stock in companies that the FDA regulates. Big head slap here. If only he was a horse show commissioner previously, but nope, he became Deputy FDA Commissioner in 2002. So for nearly four years the #2 guy at the FDA was lying about his interests.

That isn't the only thing questionable to come out of the FDA recently. In March 2006, 's Food Standards Agency released a report that identified high levels of benzene, a carcinogen, in soft drinks containing benzoates and ascorbic acid. The levels were so high they were above WHO's (world heath organization) limit of 10ppb for safe drinking water. Meaning those soft drinks were really, really bad for you if you're a heavy soda drinker. The FDA also conducted a long term study between 1996 and 2001 showing extremely high amounts but those results have been discounted. A problem with their analysis technique actually creating more benzene. For five years they got it wrong but they tried again in May 2006.

From the EPA, "The US Environmental Protection Agency (EPA) has established the maximum allowable level for benzene in drinking water to be 5 ppb." The new study released in May showed 4 out of 100 soft drinks rating more benzene than the maximum allowed by the EPA. Two of those drinks had 15-18 times the limit. This may sound sensational since at even 10ppb you have to drink quite a bit in order to take in a significant amount. Nevertheless, at nearly 80ppb, the amount registered by two of the drinks, that amount is quite a bit lower.

In the British study, the manufacturers were asked to recall the batches of soda that were above the threshold. Yet the FDA did not see a need. From the FDA report, "Manufacturers either have reformulated or are reformulating products that have been identified as containing greater than 5 ppb benzene." The soda identified as having the highest levels wasn't even shown to be reformulated. I'm sure this is old news. It's probably been taken care of by now. But why didn't someone there go out the day after making these findings and say "Let's stop selling stuff that has poison in it until we KNOW it's gone". Or until its "acceptable" enough for the FDA. Evidently being in a clearly unacceptable range wasn't enough for that to happen.

From a press release dated May 19^th:

"The results of CFSAN's 2005/2006 survey indicate that the levels of benzene found in soft drinks and other beverages to date do not pose a safety concern for consumers. Almost all of the samples analyzed in our recent survey contained either no benzene or levels below 5 ppb."

My problem with this is while they tested 100 types of soft drink, seven of those were actually juices or juice blends. Four percent tested as being too high but unless you knew to go looking at the data you'd never know. what they are. The drinks are not identified in any press release that I've come across so I've linked to the data so you can see for yourself. And there are over 450 different types of soda sold in the If the percentage holds then over a dozen drinks could be beyond safe limits. The FDA was remiss in not having those two top offenders removed temporarily at a minimum, and in not issuing warnings to consumers.

Other evidence that the FDA has divided interests is that it censors health information when it is used to promotoe dietary supplements. This is not to say that there are not frauds in the supplement industry. However we're talking about supplemets with well documented benfits. The FDA has prevented makers of calcium supplements from using well documented studies that showed calcium helped with bone loss. How many broken bones in the elderly could have been prevented?

More egregiously, they prevented companies that sold folic acid from informing women that taking just .4 milligrams a day could prevent birth defects. Over this four year period between 1992-1996 that information could have resulted in a reduction of 40%, or up to 10,000 babies born with preventable birth defects. Some of those defects resulted in spina bifida, others resulted in death. This censorhip was despite the fact that in 1992 the US Public Health Service recommended that all women of childbearing age consume 400 micrograms (0.4 mg) of folic acid daily. The UPHS operates under the Surgeon General. The FDA was preventing dissemination of information directly supported by the federal government.

Even if the FDA has been censoring this information with good intentions that concern has been misplaced. A bill has been introduced, the Health Protection Act (HR 4282) that would prevent the FDA from doing such things as denying access to articles that describe how nutrients interact with disease. This is basic information that should be freely available. The act would allow makers of these products to refer consumers to the information so they (you) can decide for themselves. This bill is still in committee stage, which many bills never make it out of. It is vital that we take a stand for free speech and demand access to information relating to our health. Please see the link for more information.

Yet one more evidence of conflict with its purpose and it's administration are the cases of efforts to suppress research by the FDA's own scientists. Vioxx, the diabetes drug Rezulin, and many others have come under scrutiny by FDA reviewers but management pressured scientists to drop the matters. The case of Dr. David Graham, the Vioxx whistleblower, is especially troublesome. I highly recommend reading his testimony to get an idea of what kind of suppression was taking place. By coming forward David Graham possibly saved your life or the life of a loved one.

Those are just a few examples of complete dissonance between the FDA's stated purpose and the actions and motives of the people working there. Pharmaceutical companies suppied nearly half of the FDA's budget in recent years because of "user fees" supplied in exchange for fast tracking certain medications. How can we still assume that they operate without bias and with best intentions? Easy. We can't.

I have no grudge against the FDA and most of my life I've assumed they're doing things for the right reasons. Yet right now I find myself looking for answers about what's healthy for my family and it's hard to know where to start. It doesn't take much research to see that the FDA policies often do not reflect the best science or best actions on part of the American people. Whether it's through sluggishness of beaurocracy, political agendas (remember the Plan B controversy?) or corporate influence their decisions need to be examined with an informed and skeptical mind.