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FDA Myths and Money

Acting FDA Commissioner Dr. Lester M. Crawford Outlines Science-Based Plan for Dietary Supplement Enforcement

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), today outlined the agency’s science-based approach to protecting American consumers from unsafe dietary supplements.

Dr. Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately. Through DSHEA, which sets up a distinct regulatory framework for dietary supplement products, Congress attempted to strike a balance between providing consumers access to dietary supplements and giving FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded.

“FDA is absolutely committed to protecting consumers from misleading claims and unsafe products,” said Dr. Crawford. “Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose.”

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. “We will continue to aggressively enforce DSHEA against unsafe or mislabeled products,” Crawford said.

In March FDA requested that 23 companies cease distributing dietary supplements containing androstenedione, which are marketed to stimulate testosterone and muscle growth but have anabolic steroid effects in the body.

Over the next several months FDA will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe supplements and false or misleading supplement labeling claims.

FDA is also developing regulations for industry on good manufacturing practices (GMPs). When finalized, this rule, proposed last spring, will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled.

FDA is, in addition, putting dietary supplement labeling under closer scrutiny. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.

To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. FDA expects to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological and clinical trial data) evidence-based reviews, and adverse event information — the approach that formed the scientific foundation for FDA’s recent rulemaking on ephedra.

Supplement labels can make claims about the impact of a supplement on the structure or function of the body, but the claims must be truthful and not misleading. Two weeks ago, FDA sent warning letters to 16 firms to stop making false claims for weight loss. The FDA plans, in addition, to issue guidance on what data would substantiate such claims.

FDA’s rulemaking on dietary supplements containing ephedrine alkaloids became effective on April 12, 2003. Last week the federal district court supported the agency’s rule by declining to issue a temporary restraining order sought by the industry.

When DSHEA was passed a decade ago, there were about 4,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, which cannot be put on the market unless a high threshold of evidence about their safety and efficacy is met, and that, like foods, such dietary supplements should in general be given the benefit of the doubt as to safety.

A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements and that there are about 29,000 such products on the market, with another 1,000 new products introduced each year.

Says FDA, industry can do more to banish bad products

By Kathleen Doheny

HealthDay Reporter

THURSDAY, April 1 (HealthDayNews) — The dietary supplement industry should be forced to disclose potential health problems with their products, but the U.S. Food and Drug Administration can legally weed out the bad supplements without first proving they are harmful to humans.

That’s the conclusion of a report, issued Thursday by a panel of experts at the National Academy of Science’s Institute of Medicine and National Research Council, which aims to give the FDA guidance in assessing the safety of supplements.

The report provides a “scientific framework” for assessing their security, said Barbara Schneeman, the committee chairwoman and a professor of nutrition at the University of California, Davis.

Representatives from the supplement industry said they need time to digest the 370-page report before issuing a formal statement. But one spokesman pointed out that the committee is top-heavy with academics and lacks representation from the $16 billion-per-year dietary supplement industry.

During a news conference to release the report, Schneeman said the new framework works within the parameters already established by the Dietary Supplement Heath and Education Act of 1994 (DSHEA), which regulates supplements in the same way as foods and does not require manufacturers to provide safety data on their product.

“A key point is that the FDA does not have to find direct harm to people” to determine that a supplement poses a risk, she said.

FDA officials have long complained that the law has tied its hands in getting rid of harmful supplements because they felt the burden of proof was on them.

But the report says the agency can work within the existing law. The FDA would not have to prove an ingredient is unsafe to humans, but that it could be held to a lesser standard — demonstrating significant or unreasonable risk, according to the report.

Schneeman said that about 29,000 dietary supplements are available for American consumers to buy, and that most are safe. A notable exception, of course, is ephedra. Last December, the FDA issued a consumer alert on supplements containing ephedra, urging the public not to buy them. It issued a notice to manufacturers advising them that it would publish a final rule stating that ephedra supplements pose an unreasonable health risk.

Because supplements are regulated like foods instead of drugs — meaning they are considered safe unless proved otherwise and are not required to be tested clinically before they reach the market — the onus is on the FDA to determine whether a supplement is harmful.

In the new framework, the scientists who put it together describe how other types of data besides safety in humans — such as animal tests or information on similar substances — can be used for evaluation purposes.

The framework includes a process for prioritizing, evaluating and describing available information to establish the risk of harm along with a set of scientific principles that serve as guidelines for evaluating risk to human health.

Currently, Schneeman said, manufacturers of supplements are not required to notify the FDA if an adverse event occurs after the supplement is on the market. “The law should be modified to require such reporting,” Schneeman said.

Currently, the Office of the Inspector General estimates the FDA receives reports on less than 0.5 percent of all adverse events associated with supplements.

In addition to providing the scientific framework, the committee also recommends that “health professionals should be educated to report health concerns [about supplements] and encouraged to use them.” The FDA’s toll-free number — 800-FDA-1088 — should be publicized and used more frequently, she added.

“We recommend that Congress provide the FDA with additional funding so it can more effectively protect the public health [from supplement dangers],” she said.

Among other recommendations: manufacturers should be required to provide the FDA with all data about the safety of the product to initiate the 75-day pre-marketing review period; that when a supplement formula changes, it should be subject to regulatory oversight; and that better labeling be provided about the product so consumers can assess its safety.

Phil Harvey, chief scientific officer for the National Nutritional Foods Association, an industry group, said his organization has “no official position [on the report] until we have an opportunity to read it.”

“If the process to evaluate the safety is supported by the industry or based on good evidence-based science, I would think we would support that,” he said.

However, Harvey said the committee, which includes many university professors, seems to lack representation from the supplement industry. “I don’t see the committee as being balanced,” he said. “There needs to be more of a balanced working relationship between the industry, academia and the government.”

The report was generated in response to an FDA request in which officials asked for expert opinion on how it could do a better job evaluating dietary supplements, Schneeman said.

More information

You can read the report by visiting the National Academy of Sciences (books.nap.edu ). For information on dietary supplements, visit the National Nutritional Foods Association (www.nnfa.org ).

SOURCES: National Academy of Sciences news conference, April 1, 2004; Phil Harvey, Ph.D., chief science officer, National Nutritional Foods Association, Newport Beach, Calif.; National Academy of Sciences report, Dietary Supplements: A Framework for Evaluating Safety

Death by Medicine
Natural medicine has come under attack as pharmaceutical company lobbyists push lawmakers to deprive Americans of the benefits of dietary supplements. Drug-front groups have implemented slanderous campaigns in attempts to undermine the value of natural health lifestyles.These attacks to natural medicine prompted an independent review of government-approved medicine, which revealed that conventional medicine was the leading cause of death in the United States. This review of government health statistics showed that in most cases, American medicine does more harm than good. Compelling evidence from this study unveiled astounding statistics on the 783,936 deaths per year that have resulted from conventional medicine.The purpose of this article was to memorialize the failure of the American medical system by exposing the horrifying statistics of the inadequacies of today’s health care system with the goal of beginning some meaningful reform.

Highlights from the findings in the review:

  • U.S. health care spending has reached $1.6 trillion in 2003, which represents 14 percent of the nation’s gross national product.
  • In a 1992 survey, a national pharmacy database found a total of 429,827 medication errors from 1,081 hospitals.
  • In 1974, 2.4 million unnecessary surgeries were performed that resulted in 11,900 deaths compared to the year 2001, where 7.5 million unnecessary surgeries were performed resulting in 37,136 deaths.
  • A 1998 study reported an estimated 106,000 deaths from prescription medications per year.
  • Nearly 9 million people were unnecessarily hospitalized in 2001.

Here are additional reasons why the traditional paradigm is flawed:

  • Studies have found that the 41 million Americans without health insurance have an increased risk for dying prematurely and not receiving appropriate medical care.
  • 20 percent of all causes of death occur in nursing homes.
  • More than 30 percent of nursing homes in the United States were cited for abuses, exceeding over 9,000 violations.
  • A study of a 100-bed sub-acute care hospital revealed that only 8 percent of the patients were well nourished, 29 percent were malnourished and 63 percent were at risk of malnutrition.

 

Drug Companies are Top Health Care Lobbyists

According to a study, pharmaceutical companies have spent more money lobbying Congress than other health care organizations. A slowing has been seen in lobbying by physicians, which suggests a decline of their political influence.

Investigators found that health care lobbying expenditures totaled $237 million in the year 2000, which was more than any other industry including agriculture, communications and defense. These figures were strong indicators of the impact of health care issues to varied interest groups.

Ranking of money spent on lobbying:

  • Drug companies–$96 million
  • Doctors and other health care professionals–$46 million
  • Hospitals and nursing homes–$40 million
  • Health insurance and managed care organizations–$31 million
  • Advocacy and public health organizations–$12 million

Another study showed that legislators wanted further input from physicians regarding public health concerns and attributed their credibility with the public as a way to offset the deep pockets of drug companies.

The Lobbying Disclosure Act of 1995 requires several actions of the lobbyist including submitting detailed biannual reports and listing the spending amounts on lobbying activities. Experts claimed that the Lobbying Disclosure Act could be stronger if it demanded more in-depth reporting such as specifying the legislation discussed and the defining the positions supported by lobbyists.

Individual Organizations with the highest lobbying expenditures:

  • American Medical Association–$17 million
  • American Hospital Association–$10 million
  • Pharmaceutical Research & Manufacturers of America–$7 million
  • Schering Corporation–$7 million
  • Health Insurance Association of America–$7 million
  • Blue Cross/Blue Shield–$6 million
  • Eli Lilly & Company–$5 million

Lack of Vitamins and Minerals Impairs a Third of World Population


NEW YORK, 24 March 2004 — As many as a third of the world’s people do not meet their physical and intellectual potential because of vitamin and mineral deficiencies, according to a report released in New York today by UNICEF and The Micronutrient Initiative.The report is accompanied by individual Damage Assessment Reports that present the most comprehensive picture to date of the toll being taken by vitamin and mineral deficiency in 80 developing countries.”Everyone who cares about the future of children and the development of nations should heed this report,” said UNICEF Executive Director Carol Bellamy. “The overwhelming scope of the problem makes it clear that we must reach out to whole populations and protect them from the devastating consequences of vitamin and mineral deficiency.”

Unless action against vitamin and mineral deficiencies moves onto a new level, the developing world’s children will remain at risk of never reaching their full potential, the report concludes. And the UN will not achieve its goals of eradicating extreme poverty, improving maternal health and reducing child mortality by two-thirds by 2015.

The severe effects of vitamin and mineral deficiencies, such as anaemia, cretinism and blindness, have long been known. The report sheds new light on other problems caused by less extreme deficiencies. For example:

  • Iron deficiency impairs intellectual development in young children and is lowering national IQs.
  • Vitamin A deficiency compromises the immune systems of approximately 40% of children under five in the developing world, leading to the deaths of 1 million youngsters each year.
  • Iodine deficiency in pregnancy is causing as many as 20 million babies a year to be born mentally impaired.

“Resources and technology to bring vitamin and mineral deficiencies under control do exist,” said Venkatesh Mannar, president of The Micronutrient Initiative. “What we need is the will, the effort and the action to fix this problem.”

Methods that have worked in industrialised nations are now so inexpensive and available that they could control vitamin and mineral deficiencies worldwide, Bellamy said.

Chief among them are food fortification, adding essential vitamins and minerals to regularly consumed foods; and supplementation, reaching out to children and women of childbearing age with vitamin and mineral supplements in the form of low-cost tables, capsules and syrups. Also essential are public education and controlling diseases like malaria, measles, diarrhoea, and parasitic infections that inhibit the absorption and utilization of essential vitamins and minerals.

These methods have resulted in significant gains during the past decade. A sustained effort to add iodine to salt consumed by two-thirds of the world’s households has protected approximately 70 million newborns a year, in some degree, against mental impairment. And more than 40 developing countries are now reaching two-thirds or more of their young children with at least one high-dose vitamin A capsule every year. The effort to date is estimated to be saving the lives of more than 300,000 young children a year and over time preventing the irreversible blindness of hundreds of thousands more.

The report calls for the food industry to develop, market and distribute low-cost fortified food products and supplements and for governments to create a supportive legislative environment and standards enabling environments for the control of vitamin and mineral deficiency through education and legislation.

“All children have the right to a good start in life,” said UNICEF Deputy Executive Director Kul Gautam, who launched the report in New York during the 31st session of the annual meeting of the UN Standing Committee on Nutrition. “With nearly a third of the planet affected in some way by a problem for which a clear solution exists, anything less than rapid progress is unconscionable.”

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