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FDA Failing to Protect Americans, Consumer Groups Charge

June 27, 2006

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While the Food and Drug Administration (FDA) is in the self-congratulatory throes of its 100th anniversary, leading independent experts on nutrition, food safety, and drug safety say the agency is failing to protect Americans.

While the beleaguered agency obediently rushes expensive new drug therapies on the market, it does virtually nothing to help reduce the toll of diet-related and drug-induced disease in America, according to Public Citizen's Health Research Group and the Center for Science in the Public Interest (CSPI).

The FDA is scheduled to mark the 100th anniversary of the passage of the 1906 Pure Food and Drug Act at a June 30 ceremony at the Harvey Wiley Federal Building in College Park, MD. That building is named for the reform-minded U.S. Department of Agriculture chemist who became the first director of the Bureau of Chemistry, which later became the FDA.

"FDA was our country's first consumer protection agency and Americans have relied on FDA to ensure the safety of their food and drugs for 100 years," said Representative Henry A. Waxman. "Under the Bush Administration, FDA has undermined enforcement and betrayed its consumer-first legacy. FDA must start enforcing the law and return to a culture that places public health concerns ahead of industry profits."

"The FDA's centennial is not so much a time to celebrate, but to mourn the FDA's gradual descent into irrelevancy," said CSPI executive director Michael F. Jacobson.

"The great Republican president Theodore Roosevelt would be sick to his stomach if he could see how Harvey Wiley's hard-charging tiger of an agency became such a pliant pussycat."

According to Public Citizen's Health Research Group, some of the problems and failures at the FDA include:

• User fees The FDA's increasing reliance on so-called user fees from drug and medical device companies encourages the agency to treat those companies more like fee-paying customers. Instead of being fully funded by the government, FDA took in $380 million in user fees in the 2006 fiscal year. Former FDA official Janet Woodcock stated that the law authorizing such fees creates a "sweatshop mentality" at the agency's Centers for Drug Evaluation and Research.

• No Learning from Drug Mistakes In testimony before the Institute of Medicine, Public Citizen Health Research Group director Sidney M. Wolfe, MD, cited 13 instances of drug approvals which either should not have been approved (including Crestor, Rezulin, and others), or should have been restricted (Accutane and others) or withdrawn (Baycol, Seldane, and others) earlier than they were.

• Tobacco Failures Five companies illegally market and promote laser treatment for smoking cessation. Public Citizen last week petitioned the FDA to crack down on those companies, since the FDA hasn't approved the device and there's no evidence the treatment works.

Consumers who are convinced to pay up to $399 for laser treatment may be diverted from real programs that work, such as nicotine gum or patches—thus fewer smokers will be helped to quit. And, though it had essentially removed nicotine-containing beverages from the market in 2002, those drinks have reappeared.

Just this month, NICLite, which the company breathlessly says is the "World's only Nicotine Replacement Drink!," and that it is "classified as a Dietary Supplement by the FDA," began a marketing campaign.

According to Wolfe, either the company is lying about the status of these products or the FDA inexplicably reversed itself and declared that they can legally be sold as dietary supplements. Either way, it represents a failure of the FDA to enforce the law of the land.

"The FDA's 100th anniversary propaganda campaign hides and denies the many ways the agency is engaging in an unprecedented assault on the American public on behalf of its drug, device, food, and other industry ‘clients,'" said Wolfe.

CSPI says failures on the food side of the FDA include:

• Obesity Over the past three decades, rates of obesity have doubled in young children and adults, and tripled in teenagers. In 2003, then-Commissioner Mark B. McClellan declared FDA's intention to "confront the obesity epidemic ... to help consumers lead healthier lives through better nutrition."

Three years later, according to CSPI, the agency has done essentially nothing. Even with a food that's a major contributor to obesity—soda—FDA has declined to place health notices on cans and bottles, require added sugars to be listed separately on labels, or to require multi-serving containers to list the number of calories for the whole container.

• Heart Disease One of the most potent promoters of heart disease is the trans fat in partially hydrogenated oil. Though after a 10-year slog the FDA finally required trans fat to be listed on nutrition labels—spurring some manufacturers to abandon the oil—the FDA has done nothing to get restaurants to disclose or eliminate it.

In 2004 CSPI petitioned the agency to ban partially hydrogenated oil and, until such a ban, to require disclosure in restaurants, but the FDA has not acted. The result: thousands of unnecessary premature deaths every year.

• High Blood Pressure Perhaps the single most harmful substance in the food supply gets zero attention from the FDA—sodium chloride, or salt. CSPI and the American Medical Association want FDA to revoke the "Generally Regarded as Safe" status of salt and to treat it as a food additive, subject to reasonable upper limits in packaged foods.

In 2004, the head of the National Heart, Lung, and Blood Institute estimated that cutting the sodium content of the food supply in half would save 150,000 lives per year.

• Fraudulent Labels Of 11,000 employees, the FDA tasks a grand total of four people at headquarters to police food labels. Thus, supermarket shelves are graced with carrot cake virtually without carrots, fruitless "fruit snacks" made with high fructose corn syrup, "whole wheat" products with a lot of white flour, and so on.

CSPI says the most significant FDA labeling initiative in recent years was an industry-written initiative to let manufacturers place misleading "qualified health claims" on food labels. FDA's own research found that the program confused consumers, but the program, championed by food companies, continues.

• Food Safety Faced with the emergence of dangerous chemicals (such as mercury or acrylamide) in food, the FDA takes years before acting—and even then, its response is typically tepid. Faced with outbreaks of bacterial pathogens in food, FDA is similarly nonresponsive: Salmonella in eggs could be all but eliminated with finalized on-farm regulations to control the hazard, but those have been delayed for years.

Shellfish contaminated with deadly Vibrio vulnificus kill 20 or so people every summer, but FDA relies on an industry-funded partnership with state governments to ensure shellfish safety.

"A scrappy nonprofit like CSPI, with one litigator on staff, forced labeling changes from major companies like Tropicana, Frito-Lay, and Pinnacle Foods," said Jacobson. "Yet when we hand the FDA neatly wrapped complaints on a silver platter, it just ignores them."

• Industry Capture The FDA often relies on advisory committees made up of outside experts to offer science-based advice, particularly on approvals of drugs and medical devices. But those panels often include—and are sometimes dominated by—scientists or researchers who have direct financial relationships with the companies whose products are under scrutiny.

In recent years, FDA advisory committees evaluating antihypertensives, various diabetes drugs, and the pediatric use of anti-depressants, have all included industry-funded scientists. On one committee, 10 of 32 panelists investigating the controversial painkillers known as COX-2 inhibitors, including Vioxx, had ties to the makers of those drugs. CSPI and Public Citizen acknowledge that the FDA has many hard-working, diligent civil servants who need more resources to do their jobs effectively.

But both the Administration and Congress have hampered the agency: the Administration, by leaving the agency rudderless and without a permanent commissioner for roughly 70 percent of the Bush presidency; and Congress, by abdicating much of its oversight responsibility, and by slashing the headquarters staffing of the food side of the agency by 11 percent since 1978.

Much of the attention the Administration does pay to the agency comes in the form of unwelcome political interference, the groups say. The FDA's failure to approve the over-the-counter use of the contraceptive Plan B is one case where the agency has been accused of letting politics, rather than science, rule the day. (Susan Wood, the assistant FDA commissioner for women's health, resigned over the matter, citing political interference from then-Commissioner Lester Crawford).

In April, an out-of-the-blue FDA declaration that marijuana has no medical benefit seemed politically motivated, since it contradicted the findings of a 1999 science panel that said it did.

"As we celebrate the 100th anniversary of this important agency, there are too many instances in which it appears to be moving back to the 19th century, when industry did whatever it wanted," said Wolfe.

"All too often, the FDA seems to forget that it is a regulatory agency with legally mandated responsibilities to protect the public."

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