The 2010 Food and Drug Administration: It’s not your father’s FDA. Or at least it’s not former President George W. Bush’s FDA.
President Barack Obama wasted little time during his first year in office turning the agency into a tougher, more streamlined watchdog over the nation’s food, supplements, drug and cosmetic industries. And with a bigger budget and proposals for stricter regulations combined with Obama’s Food Safety Working Group, the FDA is aiming to continue on that path in 2010.
But the efforts to make food, supplements and personal care products safer and track down problems faster could result in higher costs for a natural products industry already beleaguered by a down economy. “There’s a different philosophy under Obama than under the old administration,” says Mark Mansour, a partner at the Washington, D.C.-based law firm Bryan Cave who practices food and drug law. “The FDA has made it very clear that there is going to be very aggressive enforcement. The burden of responsibility has shifted to industry. Companies are going to be held to very high standards.”
The FDA’s job
The FDA is charged with ensuring that “foods are safe, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public,” according to its website, fda.gov.
For drugs and supplements, the FDA’s job includes overseeing product approval, over-the-counter and prescription drug labeling and drug manufacturing standards. For food, it includes labeling, safety of all food products except meat and poultry (which are regulated by the U.S. Department of Agriculture) and bottled water. For cosmetics, it includes safety and labeling.
The agency has the authority to inspect manufacturing and processing plants, conduct investigations, issue warning letters and assess civil money penalties for violations. In the case of outbreaks such as E. coli or salmonella, it can request that manufacturers or processors issue recalls, but doesn’t yet have the authority to mandate recalls.
Aggressive oversight coming
In an August 2009 speech to the Food and Drug Law Institute, barely two months after she took over as FDA commissioner, Margaret Hamburg said some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and that “in some cases, serious violations have gone unaddressed for far too long.” A strong FDA, Hamburg said in her speech, “enforces the law.” She said the FDA must be “vigilant … strategic … quick … and visible.”
Hamburg outlined initial steps that were put into action quickly and will continue in 2010:
The FDA has established timelines for the food, supplement and drug industry to respond to inspection findings, generally giving no more than 15 days to respond before a warning letter is issued.
The warning letter process has been streamlined by limiting FDA centralized review of the letters. Warning letters can go to any industry player, from manufacturers to retailers.
The FDA claims it will work quickly to follow up on corrective action taken by the industry after a warning letter is issued or a major recall occurs.
The agency also says it’s prepared to take immediate action in response to public health risks, perhaps proceeding before issuing a formal warning letter.
The result of this vigorous oversight and no-nonsense approach: a number of warning letters, a “dramatic uptick in investigations and inspections of plants” and aggressive action in following up reports of problems, according to Mansour. “[The FDA] doesn’t have mandatory recall, but it’s acting like it does,” he says.
Susan Brienza, a regulatory attorney with the Denver office of the Washington-based firm Patton Boggs, pointed to letters sent last year to dietary supplement companies warning they could not make swine flu claims, either implied or explicit. In her August speech, Hamburg noted that the FDA sent 65 warning letters in response to websites selling fake H1N1 cures and slowed the growth of such sites from 10 a day to two a week.
In the coming year, Mansour expects to see the FDA take a more forceful approach against companies that violate regulations on everything from food to supplements. “We’ll see a lot of punitive action,” he says. “Don’t be surprised to see criminal negligence charges.”
In addition, the FDA is updating food regulations and perhaps enacting new legislation in order to ensure a safe, transparent food, supplement and drug supply. (For details, see “FDA priorities” right). Although a traceable food supply can serve retailers and consumers by ensuring safety, the potential new rules and tougher guidelines, including possible registration and user fees, concern natural products companies and farms that are often smaller and don’t have the employees or the resources to meet the stringent requirements. The message to smaller operations “is not good,” says Mansour. “It’s going to be expensive.”
Jane Hoback is a writer and editor in Denver.