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Lawyers, companies and researchers now have valuable access to complaints of harm associated with FDA-regulated food, dietary supplements and cosmetics.
The new public-facing Food and Drug Administration database compiles adverse-event reports that consumers, doctors and companies send the FDA. These reports were previously available only through specific Freedom of Information Act requests.
The agency uses the reports to identify harmful products that may need further investigation.
Both consumer and industry groups say the database will prove helpful to a variety of users about potential product problems.
“It’s a go-to place,” Michael Jacobson, co-founder and president of the Center for Science in the Public Interest in Washington, told Bloomberg BNA Dec. 14. The group tracks food safety issues.
“If somebody, like a poison-control center, has concerns, they can go and see if there happen to be some reports,” Jacobson said.
The adverse-event reports received by the agency’s Center for Food Safety and Applied Nutrition go back as far as January 2004, according to an FDA Federal Register notice.
CFSAN regulates all cosmetics and food under FDA purview, including food additives, color additives and dietary supplements. The Department of Agriculture, rather than the FDA, regulates meat, poultry, and certain processed egg products.
The FDA receives both mandatory and voluntary adverse-event reports related to dietary supplements, but only voluntary reports for food, food additives and cosmetics.
“So there are 75,000 reports over 10 years, that’s 7,500 per year,” Jacobson said. “Not a huge number, but it’s certainly better than anything I’ve seen before.”
The agency said the information is significant because the FDA doesn't have pre-market authority over foods and cosmetics. Thus, identifying possible risks through postmarket surveillance is “critical,” it said.
The FDA said it believes that making the data public through the database “may increase the number and completeness of the adverse event reports we receive.”
Users who stand to benefit from the database include researchers, like those at CSPI, and doctors.
“I would use it to look for possible problems,” said Jacobson, who has written books and reports on health and safety issues related to food.
The new data can be particularly helpful in the area of food-safety issues, Jacobson said, because the FDA has “a very limited budget, and traditionally has been behind the curve in identifying problems and trying to correct them.”
The database “gives some hint about hot spots in the food supply,” Jacobson said. “If you see large numbers, it’s probably not some random consumer making a spurious association between a headache and something they ate.”
Plaintiffs’ lawyers and companies, including product makers, also are expected to be interested in the information.
“Some plaintiffs’ attorneys might use it to look for instances where there are numerous adverse reaction reports, just to get some hint” of a potential area of litigation to explore, Jacobson said.
Defense attorneys might also be interested in a database that could point them to companies in need of legal help.
“Competitors might use it,” Jacobson said. “Companies might use it, even if they weren’t aware of allegations of harm from their products, to see what it says.”
Two industry trade groups who applauded the database's increased transparency agreed the now-public data could be useful to their members.
“We look forward to exploring ways to possibly use this new reporting system as a means for further enhancing the safety of our products,” Brian Kennedy, a spokesman for the Grocery Manufacturers Association in Washington, said.
Lisa Powers, a spokeswoman for the Personal Care Products Council, likewise said the Washington-based cosmetics trade group considers adverse-event reporting and post-market surveillance “necessary and important” to cosmetic safety.
The FDA’s database provides one line for each incident, showing brand and product names, consumer demographics, the symptoms they say they experienced and their health outcomes.
The FDA cautioned that the database has limitations. The information appears as it was reported to the agency, doesn’t represent agency conclusions, and doesn’t reflect certainty about whether the product caused the symptoms, the FDA said on its website.
“Some reports to FDA do not necessarily include all relevant data, such as whether an individual also suffered from other medical conditions or used other products or medications at the same time,” the agency said.
“Another limitation is that the number of reports in this database will be a tiny, tiny percentage of adverse reactions that actually occur,” Jacobson, of CSPI, said.
He pointed to Marlow Foods’s Quorn veggie burgers, for which there are about 100 entries in the database, mostly involving abdominal pain and other gastrointestinal symptoms.
“We, little CSPI, have received hundreds of reports from Americans in those years,” he said. “These are very small samples of the number of adverse reactions that are actually occurring.”
Powers, of the cosmetics trade group, said the FDA’s reporting system also receives “complaints about off-taste or color of a product, defective packaging, and other non-medical issues.”
To contact the reporter on this story: Martina Barash at MBarash@bna.com
To contact the editor responsible for this story: Steven Patrick at email@example.com
The database is available for download at http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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