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FDA Shifts Position—Now Has Concerns about BPA Risks

In a shift of position, the U.S. FDA is expressing concerns about possible health risks from bisphenol A, or BPA, a widely used component of plastic bottles and food packaging. The agency declared BPA safe in 2008.

But the FDA now has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.”

The action is another example of the drug agency becoming far more aggressive in taking hard looks at what it sees as threats to public health over the past year. In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.

Concerns about BPA are based on studies that have found harmful effects in animals, and on the recognition that the chemical seeps into food and baby formula. Nearly everyone is exposed to BPA, starting in the womb.

Dr. Sharfstein said the drug agency was also re-evaluating the way it regulates BPA.

The substance is now classified as a food additive, a category that requires a cumbersome and time-consuming process to make regulatory changes. Dr. Sharfstein said he hoped its status could be changed to “food contact substance,” which would give the F.D.A. more regulatory power and let it act more quickly if it needed to do so.
Dr. Mercola's Comments:

You might be surprised to learn that "flexible packaging" -- the pouches and films your food comes in -- is big money, representing a $21.3 billion per year industry in the United States that is growing by 3.5 percent annually.[i]

And BPA is one of the biggest players in the wrapping industry.

Last year, more than 6 billion pounds of BPA was made, representing nearly $7 billion in sales[ii] . US companies that make BPA are Bayer Material Science, Dow Chemical Company, SABIC Innovative Plastics (formerly GE Plastics), Hexion Specialty Chemicals, and Sunoco Chemicals.

It’s no surprise that the chemical people would conspire with the food manufacturers to keep BPA facts under wraps.

You not only ingest the contents of your food but some of the contents of the packaging as well. Unfortunately, the chemicals you ingest as a result of your food containers have never been a high priority of the FDA.

FDA Officials Claim Their Hands are Tied

The FDA has admitted it needs to overhaul its regulatory framework because the structure limits its ability to regulate BPA production.

A quirk in the rules allows BPA makers to skirt federal legislation.

BPA, which was first manufactured way back in 1891, was later developed as a plasticizer in the early 1960s. It was classified in 1963 as an indirect food additive and is listed among the 3,000 or so chemicals categorized as GRAS ("generally regarded as safe").

This outdated GRAS designation is what exempts BPA from scrutiny.

According to the FDA’s regulations, a substance granted GRAS status is not subject to FDA review.

Sharfstein told the Milwaukee Journal Sentinel2 that the agency can try to get companies to volunteer the information, but it’s probably going to require a change in the law.

The fact that BPA makers are on the "Honor System" about disclosing information doesn’t give me a warm and cozy feeling about its safety.

FDA officials, including Sharfstein, Lynn Goldmann (a consultant to the FDA), and acting chief scientist Jesse Goodman, all expressed how frustrated they are with the antiquated framework of the FDA’s regulatory process.

Perhaps some of the FDA officials are coming clean.

It remains to be seen whether these sentiments are genuine or simple attempts to tell journalists what they want to hear. Either way, the FDA is certainly not without blame.

The FDA explains these limitations via an "update" on its website[iii]:

"Current BPA food contact uses were approved under food additive regulations issued more than 40 years ago. This regulatory structure limits the oversight and flexibility of the FDA.

Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation. There is no requirement to notify the FDA of that use.

For example, today there exist hundreds of different formulations for BPA-containing epoxy linings, which have varying characteristics. As currently regulated, manufacturers are not required to disclose to FDA the existence or nature of these formulations.

Furthermore, if the FDA were to decide to revoke one or more approved uses, the FDA would need to undertake what could be a lengthy process of rulemaking to accomplish this goal."

Fuel for a Legislative Fire

John Peterson Myers, the chief scientist for Environmental Health Sciences, told the Journal Sentinel that he believes the FDA’s admission of its inability to regulate BPA may fuel legislative efforts toward a ban.

Myers argues:

"Industry always uses the argument that the chemical is regulated. This shows that it is not. State and federal lawmakers need to consider that. They can't rely on this agency to regulate it if they don't have the tools to do so."

BPA in baby bottles has been banned by Minnesota, Connecticut, the City of Chicago and two counties in New York. Other measures are being considered in 30 states and municipalities.

Three cheers for our side!

A federal ban on BPA in all food contact has been proposed in Congress.

A few concerned members of Congress, who have demanded disclosures from the chemical industry, report being stonewalled by industry scientists who maintain that BPA is safe and that it’s important in preserving the integrity of canned food by allowing for high temperature sterilization, thereby preventing microbial contamination.

The American Chemistry Council, a lobby group for the chemical industry, issued a statement on January 15, 2010, denying the health hazards of BPA.

And North American Metal Packaging Alliance, a Washington-based trade group for can makers, said that there is no "readily available alternative to BPA."

It appears that the chemical industry is using tobacco industry shenanigans to hide the truth about what their products really do to you.

BPA Should Stand for "Beware -- Plastics Attack!"

The FDA has food labeling guidelines that dictate what must be listed on food packaging. That generally includes a listing of ingredients, nutrition analysis, "best if used by" dates, instructions for handling and preparation, and contact information for the company that packaged the food.

But there is no requirement that consumers are told about chemicals in the packaging itself that could be leaching into your food -- even though these are essentially inadvertent food additives!

In December of 2009, Consumer Reports reported testing 19 name brand canned foods, including:

  • Soups

  • Juices

  • Tuna

  • Green beans

The results were disappointing.

Nearly all of the tested canned foods were contaminated with BPA, including organic canned foods. BPA was even found in some cans labeled "BPA-free."

According to their estimates, just a couple of servings of canned food can exceed the daily safety limits for BPA exposure in children.

Even low-level exposure to BPA can be hazardous to your health -- the evidence has been accumulating for more than 10 years. There are more than 100 independent studies linking the chemical to serious health problems in humans, including:

10 Tips to Help You Minimize Your BPA Exposure

Until there are regulations to protect you, here are a few things you can do to protect yourself and your family:

  1. Boycott plastic shopping bags. Use reusable canvas or cloth varieties instead. (This also applies to the plastic produce bags in the grocery store.)

  2. Store your food and beverages in glass containers, NOT plastic.

  3. If you choose to use a microwave, don’t microwave food in plastic containers.

  4. Stop buying and consuming canned foods and drinks (the can linings contain plastic chemicals.)

  5. Avoid using plastic wrap altogether.

  6. Replace your plastic dishes and cups with glass varieties. Never drink your coffee or tea from a plastic cup.

  7. Avoid using plastic cups, utensils, dishes, and food storage containers. There are some containers being labeled "BPA-free," so keep an eye out for those if you choose to use plastic.

  8. Avoid drinking bottled water. Instead, filter your own water and put it in a glass bottle.

  9. Before allowing a dental sealant to be applied to you or your children, ask your dentist to verify that it does not contain BPA.

  10. Use only glass baby bottles and dishes. Use cloth diapers instead of plastic. And give your baby non-plastic toys, like varieties that are made of fabric.

It is important to be a label-reader these days, and this is a perfect example of why.

The bottom of plastic containers are marked with a recycling label that includes a number. Polycarbonate plastics, which contain BPA, usually have a No. 7 on the bottom. However, not all plastics labeled with the number 7 contain BPA. For instance, corn PLA plastic and other biodegradable and renewable resource resins are classified under 7 as well.

So when seeking to avoid BPA, look for the type of plastic -- such as polycarbonate -- rather than the number.

As always, you’re far safer replacing your plastics with glass or ceramic whenever possible.

[i] "Understanding FDA food packaging regulations," White-paper by Rohm and Haas, 

[ii] Kissinger M. "FDA says it’s unable to regulate BPA" (January 17, 2010) Milwaukee Journal Sentinel 

[iii] "Update on bisphenol A for use in food contact applications: January 2010" U.S. Food and Drug Administration