"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.”In the past, this information was available though the Freedom of Information Act, now, it will be available for researchers, companies, and of course lawyers.
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.”
Interestingly, FDA receives only about 7500 complaints per year. Not a lot when you think about the number of products sold each day to 320 million people.
The FDA updated procedures for filing complaints for consumers. FDA directs consumers on how to report non-emergency complaints. They can call the FDA Consumer Complaint Coordinator assigned for each state or to go online and report to MedWatch website.
Bloomburg BNA
https://www.bna.com/fda-food-cosmetics-n73014448792/
FDA Food, Cosmetics Data Boon for Attorneys, Companies
December 19, 2016
By Martina Barash
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.”
Data and Its Uses
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
Rest of Article - https://www.bna.com/fda-food-cosmetics-n73014448792/
https://www.bna.com/fda-food-cosmetics-n73014448792/
FDA Food, Cosmetics Data Boon for Attorneys, Companies
December 19, 2016
By Martina Barash
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.”
Data and Its Uses
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
Rest of Article - https://www.bna.com/fda-food-cosmetics-n73014448792/
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