1. Provide the title of your story or series and the names of the journalists involved.
"Dangerous Supplements" by Douglas Podolsky, Nancy Metcalf, Kimberly Kleman, Christopher Hendel, David Schipper.
2. List date(s) this work was published or aired.
September 2010 issue of Consumer Reports.
3. Provide a brief synopsis of the story or stories, including any significant findings.
Our investigation revealed a striking lack of government oversight of the $26.7 billion dietary supplement market and identified supplement ingredients that have been linked by clinical research or case reports to serious adverse events, such as cancer, coma, heart problems, kidney damage, liver damage, or death. Consumer Reports, working with experts from the Natural Medicines Comprehensive Database, an independent research group, identified the "dirty dozen" supplement ingredients. Other factors were also evaluated, including evidence of effectiveness for their purported uses, and the extent to which the ingredients are readily available, either alone or in combination products. The dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. Surprisingly, the Food and Drug Administration (FDA) has warned about at least eight of these, some as long ago as 1993; those eight supplements include chaparral, colloidal silver, comfrey, country mallow, germanium, kava, lobelia, and yohimbe. But warnings have not prevented retailers from selling supplements containing these ingredients. Our investigation showed that the FDA has not made full use of even the meager authority granted it by the industry-friendly 1994 Dietary Supplement Health and Education Act (DSHEA). The FDA has only once used its power to ban a supplement ingredient (ephedrine alkaloids) outright. We also found that, because of inadequate quality control and inspection, supplements contaminated with heavy metals, pesticides, or prescription drugs have been sold to unsuspecting consumers. Our report highlighted the risks of products marketed as dietary supplements for weight loss, sexual enhancement, and bodybuilding that increasingly are found to contain synthetic steroids or active ingredients found in prescription drugs. The FDA says hidden drugs or steroids have been found in more than 170 products marketed as supplements since 2008. As evidence of the agency's inability to properly regulate the supplements industry, Consumer Reports notes that the FDA has yet to inspect a single supplement factory in China, which has become a major supplier of raw supplement
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
We analyzed the Natural Medicines Comprehensive Database (NMCD) Professional Version, an evidence-based information resource on natural medicines compiled by an independent research group. The Database is updated daily with new findings including new interactions and safety concerns. We also searched and retrieved scientific articles using the U.S. National Library of Medicine's Web site, PubMed.gov, which comprises more than 20 million citations for biomedical literature from MEDLINE, life science journals, and online books. Working with NMCD experts, we identified a group of ingredients — out of nearly 1,100 in the database — linked to serious adverse events by clinical research or case reports. To come up with our dozen finalists, we also considered factors such as whether the ingredients were effective for their purported uses and how readily available they were to consumers. We then shopped for them online and in stores near our Yonkers, N.Y., headquarters and easily found all of them for sale in June 2010. During our reporting we learned from the Food and Drug Administration that in 2008 and 2009 the agency received 1,359 reports of serious adverse effects linked with dietary supplements from manufacturers and 602 from consumers and health professionals. But the FDA would not disclose which supplement products were involved. Therefore, on May 6, 2010, we requested those records in electronic form under the Freedom of Information Act. We also asked the FDA to identify the dietary supplements that the agency is monitoring because it has detected a potential "safety signal," along with a description of the type of serious adverse events involved. More than 8 months later, we are still waiting for the FDA to fulfill our requests. We believe it is in the public's interest to know which supplement products have been linked with such serious safety problems, and will report on this topic in the future as we receive the information.
5. Explain types of human sources used.
We conducted around four-dozen interviews in reporting this article. Among the people we interviewed were officials with the U.S. Food and Drug Administration, U.S. Government Accountability Office, National Institutes of Health, U.S. Congress, U.S. Pharmacopeia, U.S. Anti-Doping Agency, Poison Control Centers, and the dietary supplement industry. We also interviewed medical researchers who've studied public health issues involving dietary supplements, doctors who've treated patients who said they suffered supplement-related injuries, their lawyers, and attorneys for supplement companies they had sued.
6. Results (if any).
Within weeks of the publication of our September article, the U.S. Food and Drug Administration posted new information warning the public about the risks of dietary supplements, particularly those marketed for weight loss, sexual enhancement, and bodybuilding, which we focused on in our story. And on Dec. 15, the Food and Drug Administration announced a new effort to keep tainted supplements off the market, the FDA announced the following steps: " FDA Commissioner Margaret Hamburg, M.D., sent a letter to the supplements industry reminding companies of their responsibility to prevent tainted products from reaching the U.S. market. Representatives of major supplement organizations — including the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, the Consumer Healthcare Products Association, and the American Herbal Products Association — said they would support the FDA's efforts and agreed to share the letter widely within the industry. " The FDA established a new link on its website to rapidly alert consumers about tainted supplements. The agency said that after alerting the public, FDA investigators would contact the responsible firms to "immediately address" products that remain on the market or in the hands of consumers. " The FDA asked the industry to report suspected tainted supplement ingredients by e-mail at TaintedProducts@fda.hhs.gov or its anonymous reporting form "Report Suspected Criminal Activity"
7. Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
We ran a correction that a photo caption should have said the FDA determined that four supplements pictured contained — not contain — a Viagra-like drug. Those supplements have been the subject of voluntary nationwide recalls of affected products.
8. Advice to other journalists planning a similar story or project.
We found the FDA particularly slow to respond to our questions, interview requests, and FOIA requests, so make requests early, and be tenacious. For FDA alerts, advisories, and other actions, go to www.fda.gov/food/dietarysupplements. Find medical studies at nlm.nih.gov and PubMed.gov and interview the authors, who we've found are very generous with their time and expertise. The National Institutes of Health's Office of Dietary Supplements at http://ods.od.nih.gov/ is another good resource. When looking for people who claim they've suffered adverse effects, ask the experts you interview to put you in touch with patients, and check the nexis.com or other Web sites for leads. Go to Consumer Reports Health, at www.ConsumerReportsHealth.org, where, for a $19 annual subscription to the site, you can search for information about dietary supplements and other natural health products by type, brand, or ingredient. You can also view ratings of product effectiveness for various conditions and check interactions between those supplements and certain drugs.