Nutritional science for mind health products
DSM Nutritional Products
In a letter to the federal agency, the consumer interest group has underscored information it thinks should be made on all dietary supplement and over-the-counter drug labels so as to ensure consumers know how to give information on adverse events. The FDA is said to be working on putting together a guidance for industry as to how to comply with adverse events reporting (AER) requirements.
While FDA's guidance would not be binding, trade associations have said that overly detailed requirements for such labeling will burden industry unnecessarily.
An example of one point in question is the labeling of street addresses.
"To issue guidance that would require de facto label changes would cause a great deal of confusion as responsible industry and FDA work together to ensure this system provides meaningful signals," wrote the Council for Responsible Nutrition's president and CEO, Steve Mister, in a July letter addressed to the director of FDA's Center for Food Safety and Applied Nutrition, Robert Brackett.
CSPI disagrees with this:
"…the company must provide a complete mailing address, rather merely the city and state in which the firm is located," wrote Bruce Silverglade, CSPI's director of legal affairs, in the letter to the FDA.
Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers.
"The FDA is depending on the public to report adverse reactions, but without a clear label statement alerting consumers to call or write, it is possible that many adverse reactions may never be reported and the FDA will not have the data it needs to protect the public from dangerous products," said Silverglade.