A surprising treat for Halloween! Okay, how much of a geek does that make me? Yes, it is true. On Halloween, the FDA Science Advisory Board, a board of outside experts, voted unanimously to endorse a report harshly critical of the FDA’s draft safety assessment finding BPA safe.
It seems that I am always talking about bisphenol A (BPA), the key monomer of polycarbonate plastic (used for baby bottles, among other things) and also used in the lining of canned foods and beverages. Low level exposure to BPA has been linked to hormone disrupting effects in animals, and recently a large study linked BPA exposure to heart disease and diabetes, but the Food and Drug Administration (FDA) has continued to maintain BPA is safe. However, today, in a decision surprising to me, the FDA Science Advisory Board found that the FDA’s draft safety assessment for BPA is fundamentally flawed.
If you’ve been following the issue, or if you read my blog from yesterday, you’ll know that the FDA had a Subcommittee reviewing its August draft safety assessment on BPA. That safety assessment found BPA safe, but has been widely criticized for relying only 2 industry funded studies and disregarding over a 100 peer-reviewed animal studies involving low dose exposure. The FDA asked a Subcommittee to review the draft BPA safety assessment. On Wednesday of this week, the Subcommittee issued a report denouncing the FDA’s draft BPA safety assessment.
That peer-reviewed report was released just before today’s meeting of the FDA’s Science Advisory Board. The Science Advisory Board endorsed the Subcommittee’s report. These outside experts voted unanimously to endorse the Subcommittee’s report, which found that the FDA should not have excluded the scientific studies that it had excluded. The Subcommitee found that the FDA’s approach “creates a false sense of security about the information that is used in the assessment . . . as it overlooks a wide range of potentially serious findings.” In other words, the FDA creates a false sense of security in the American public about BPA’s safety.
The Subcommitee’s report criticizes the FDA’s draft BPA safety assessment for, among other things:
- failing to consider the cumulative effects of being exposed to BPA from dozens of products, severely limiting the usefulness of the FDA’s safety estimate;
- failing to consider that parents heat baby bottles in the microwave and sterilize them with boiling water, thereby potentially increasing the rate of BPA leaching;
- relying on industry funded studies that were not designed to study newborns;
- failing to include significant new reports; and
- excluding inappropriately non GLP (good laboratory practice) studies.
I was a little disturbed by the presentation from FDA Commissioner Andrew von Eschenbach. He stated, “There’s no shame in having one’s hypothesis or previous tenets questioned or disproved. That’s the purpose of science: to test hypotheses and theses appropriately and have a healthy debate about where the data do and do not lead us.” Yes, that is how science works. But, the flip side of that is that the FDA is using the American public as guinea pigs. The way that our regulatory system works is that we don’t test products before putting them on the shelf. That just isn’t how we regulate. So there isn’t a healthy debate to start – chemicals are mostly assumed to be safe. But that means if we start to see issues, such as in the case of BPA, we might need to react a little bit more quickly, especially when safe alternatives exist, such as BPA-free baby bottles. That doesn’t mean we should react too quickly, or ban products without support. But an agency charged with protecting the public’s safety also shouldn’t issue a press release just before hearing emphasizing the safety of a chemical under attack. Instead, perhaps the FDA should consider a more measured approach, guiding parents to alternate while the science is debated.
So what happens now? Well, at least from the FDA Commissioner’s position as set forth in his blog, Andy’s Take, it appears that we will have more research before the FDA takes any steps. As he states, the FDA “cannot short-circuit or avoid this process of rigorous analysis, critical assessment, and stringent validation.” That may be true, but still, you would think that the FDA would give parents directions on how to avoid BPA while the FDA keeps studying the issue.
If you want to avoid BPA, skip polycarbonate plastic and choose other options. For baby bottles, lots of manufacturers have BPA-free options. To avoid BPA in canned goods, opt instead for fresh, dried, frozen or jarred.