FDA: Weak laws, sparse resources handcuff angency

Repost via the Seattle PI

As medical studies and lawsuits point to increasing sickness and death from asbestos-contaminated talc, the Food and Drug Administration says it lacks both resources and laws with teeth to protect consumers.

In addition to personal care products, talc, a naturally occurring mineral comprised of magnesium silicate, is found in thousands of consumer products and its use is growing, according to government and industry sources. Talc has been used in the manufacturing of tires, paper, thermoplastics, polymers, paints, food products, French chalk, a dry lubricant and, according to the Drug Enforcement Administration, often for cutting illegal drugs like cocaine.

Pathologists, cancer specialists and experts in hazardous minerals have documented hundreds of cases in which they blame asbestos in talc products for causing often-fatal mesothelioma and ovarian cancer. A report released last month directly links asbestos found in a popular body powder to at least one death from mesothelioma — an almost-always-fatal cancer known to be caused only by exposure to asbestos.

“There should be a comprehensive, ongoing program by the FDA and other government safety agencies to examine talc in cosmetics, pharmaceuticals and other products for the presence of asbestos,” said James Millette, executive director of MVA Scientific Consultants and one of the authors of the study.

Yet even some scientists within the FDA believe the agency pays little more than lip service to the danger of contaminated talc.

The FDA’s laissez faire attitude towards talc goes back for decades. In April 1972, Barry Castleman, then a public health officer for the Baltimore County Health Department, wrote to the FDA requesting it investigate the possibility of dangerous levels of asbestos in talc.

Asbestos - photo via ct.gov

Asbestos – photo via ct.gov

A month later, FDA’s Dr. John Gowdy wrote back and said “The (1939) Food, Drug and Cosmetic Act states precisely that products must be shown to contain harmful or deleterious substance before they are subject to action.

“The FDA must be prepared to prove a cosmetic is harmful before it can act against it,” the senior agency official wrote.

Just last month, when asked again what the FDA was doing to ensure the safety of talc-containing products a spokesperson for the agency said that “manufacturers of cosmetic products and ingredients, do not need FDA approval before they go on the market.

“Unlike talc, however, asbestos is a known carcinogen. For this reason, FDA considers it unacceptable for cosmetic talc to be contaminated with asbestos,” said agency spokesperson Theresa Eisenman.

She added that “FDA can take action against cosmetics on the market that do not comply with the law,” but the FDA is doing virtually nothing to assure that no asbestos is present in cosmetic products.

“There is nothing at all, to keep dangerous talc from being sold all over the place because no one in our government is watching the store, so, as consumers, we’re basically flying blind,” said Castleman, who has authored five editions of a landmark book on asbestos, the law and medicine.

Many in public health look with envy at how other governments regulate products containing asbestos-tainted talc.

For example, in April 2009, South Korea’s Food and Drug Administration responded almost instantly after testing showed that hundreds of pharmaceutical and cosmetic products were contaminated with dangerous talc.

Immediately, tens of thousands of individual items – of more than 1,100 different products – were ordered from store shelves and banned from future sale. They included finished products that were imported from China or made in South Korea from raw Chinese talc. The South Korean government said the imported talc had “dangerously high, completely unacceptable, levels of asbestos.”

As word of the South Korean action spread to the U.S public health community, FDA was asked whether it was sure that talc used here was asbestos free.

The agency repeated its talc mantra that it “relies on mine operators, importers and cosmetic and consumer product makers to ensure the safety of what they sell.”

Pressure increased for FDA to address the unknown hazard, but the agency admits that not much was accomplished.

First it requested mineral samples from the owners or operators of the nine operating talc mines in the U.S. Only four complied with the request.

Makeup-set

Many cosmetics contain asbestos. Photo via asbestos.com

The agency said its cosmetic laboratories did not have the equipment needed to analyze talc for asbestos so it contracted with a private lab in Maryland to examine 34 samples of raw talc or talc-containing cosmetics.

The survey found no asbestos fibers or structures in any of the samples tested.

“The results were limited by the fact that most mines didn’t supply raw talc and the small number of samples,” said the agency.

“For these reasons, while FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination,” the FDA added with surprising candor.

Talc is used in North America in more than 4,200 different cosmetics items. It is also found in more than 40,000 pharmaceutical products as an inactive ingredient carrying the actual medication in prescription and over-the-counter drugs.

What concerns some food-industry scientists, including some within the FDA, is that the use of talc in food and in food processing is expanding rapidly. Talc has long been used as an anti-stick and coating agent for cured meats, sausages, hard cheeses, candies, chewing gum, dried fruits, and in polishing rice and in some varieties of dried peas and beans.

While the FDA says “there are no food-grade specifications for talc,” the mineral is being used as an anti-caking agent, a thickener, a base for glaze, and as a dispersing agent for food flavoring, seasonings, coloring and other additives. It is also being widely used in many powdered dried foods.

Another area where talc’s use in rapidly increasing, but rarely discussed, is in the making of olive oil, say the experts at the Olive Center at UC Davis.

Talc helps increase yields from the olives and also eliminates cloudiness, even when used with less than desirable or overripe fruit. Talc plays a major role with olives picked after heavy and lengthy periods of wet weather or at the end of the harvesting season when the olives might contain too much water.

In its examination of the relationship between asbestos and talc in 360 commercial sized and smaller U.S. talc deposits, the USGS reported that “a number of U.S. talc deposits of commercial size . . . . consistently contain talc intergrown with (asbestos) … such as tremolite and (or) anthophyllite,” and that “the amounts differ from none detected to trace to significant amounts of asbestos.”

But many safety experts are more concerned about the enormous volumes of often-cheaper foreign talc being used in the United States.

Import Genius, a commercial operation which tracks shipping activity of millions of products around the world, provided data that showed that in the last 18 months more than 1,400 shipments of talc or talc products were sent into the U.S. from 34 countries. China is the largest supplier by far.

The tally included 289 million pounds of raw talc as well as hundreds of shipping containers filled with eye shadow, mascara, foundations, body powders, dry shampoos, antiperspirants and other consumer items.

“I would be particularly worried about talc-containing products that are imported, especially from China,” said Castleman. “No one is checking products made abroad and exported here to chains to sell at low profits to fly-by-night outlets.”

The FDA has investigators who electronically monitor shipments at port and border facilities but “generally, the FDA does not physically inspect bulk ingredients like talc, said the agency, and added, “periodic examinations are conducted to ensure the security and integrity of shipments.” However, FDA declined to say when the last shipment was inspected by their agents at any port. Many experts say FDA’s reliance on manufacturers to ensure the safety of the talc they produce or use is a dangerous practice.

For decades, W.R. Grace & Co. insisted that the vermiculite it mined in Montana was free of asbestos, though the company’s own testing showed the vermiculite was heavily contaminated with the lethal fibers.

Just last month, the Third U.S. Circuit Court of Appeals ruled that a lawsuit could go forward in which plaintiffs allege that one of the country’s largest miners of talc repeatedly and intentionally concealed the presence of asbestos in its minerals _ and that it destroyed corporate records confirming the hazard.

On Sept. 3, Judge Julio Fuentes issued an opinion saying a lower court erred in dismissing the case outright against BASF, its New York law firm Cahill Gordon Reindel, and Englehard Corp., the Johnson, Vt., mine’s previous owner.

Plaintiffs allege that Engelhard “represented to its customers, industry trade groups and the federal government that the Emtal talc was asbestos free and even marketed the product as a viable asbestos substitute, thereby causing widespread and unknowing exposure to asbestos.”

A whistleblower – a research chemist at the mine – went public after his daughter died of mesothelioma. He said that tests conducted over a six-year period showed high levels of asbestos contaminating the talc.

Andrew Schneider, a two-time Pulitzer Prize-winning investigative journalist, is based in Seattle.

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