Rule changes expand FDA’s legal authority

By Todd Etshman
Posted: 5:05 pm Mon, May 16, 2011

The Food and Drug Administration recently announced its first two rule changes pursuant to the authority granted the agency by the FDA Food Safety Modernization Act signed by President Barack Obama in January.

Beginning in July, the FDA can detain food products it believes are adulterated or misbranded for 30 days.

Douglas Karas, public affairs specialist for the FDA, said the terms “adulterated” and “misbranded” refer to food that has been contaminated or causing foodborne illness. The terms can also refer to food that has an unapproved food additive or food that contains an allergen that isn’t listed on the label. A common unlisted allergen is peanuts.

Previously, the FDA had to work with state agencies such as the New York State Department of Agriculture & Markets under the state’s legal authority until the FDA could obtain a court injunction.

“It’s easier for them,” Karas said. “They have the tools to do that. Now, if we have a reasonable suspicion, we can freeze it and then get an injunction. In the old days, the only things we could stop were things causing health consequences or death.”

“We’ve had a very good relationship and we’ve worked cooperatively with [the FDA] for many years,” said New York State Food Safety & Inspection Director Stephen Stitch in Albany.

Karas said the new rules help expand and define the FDA’s legal authority, something the New York State Food Safety & Inspection director welcomes.

However, Stitch said the FDA used to rely on the state to seize or embargo the food, and that that was “an unnecessary use” of state resources.

“We must have similar regulatory foundations and this will help with that,” he said. “Anything they can do to strengthen their authority helps us. The new rule gives the FDA the same authority as states have.”

With better resources and manpower, the Department of Agriculture & Markets can physically remove adulterated or misbranded food as soon as it’s discovered.

The agencies will continue working together to enforce food safety laws but provisions of the Modernization Act should provide more manpower and resources for the FDA in the future.

Another FDA rule set to take effect on July 3 requires a food importer to inform the FDA if a food product for humans or animals has been refused by another country. Karas said importers weren’t required to inform the FDA if a food product had been refused by another country in the past. But without legal authority, the FDA couldn’t act.

“We work with the FDA on imported foods, too.” Stitch said. “It’s become a product of state agencies. It’s more of a problem [in New York].

“Thirty percent of the imported food in the U.S. comes through three New York ports,” he said. “Our inspectors are out there everyday and we find a lot of adulterated and mislabeled food that may have preservatives, allergens or food dye.”

There have been 300 food recalls a year over the past 10 years in New York, and most of them came from imported foods. Additional FDA rules will be released later this year or early in 2012 — including produce safety rules.

“They’re science based safety rules to prevent foodborne illness,” Karas said.

In addition, new rules are expected to give the FDA authority to mandate food product recall.