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Lawyers with FDA practices are in high demand as the dietary-supplement industry races to comply with sweeping Food and Drug Administration rules governing its manufacturing practices and new requirements to report consumer injuries. The manufacturing rules, which were issued 13 years after the Dietary Supplement Health and Education Act of 1994 authorized the agency to develop them, coincides with reporting requirement amendments to the Federal Food, Drug and Cosmetic Act. By the end of the year, dietary-supplement makers must start reporting consumer injuries, or so-called adverse events, associated with the supplements to the FDA. Companies need help with creating testing procedures and documentation, said Dan Troy, an FDA lawyer in Sidley Austin’s Washington office. “There’s lots and lots of legal work,” Troy said. “It will be for many of these companies a major transformation to come into compliance with good manufacturing practices that are considerably more burdensome than are in place for food.” Adverse events The rules and the adverse-event reporting legislation are the two most significant things that have had an impact on dietary-supplement regulations since the supplements law was passed in 1994, said Wes Siegner, a lawyer at Washington-based FDA boutique Hyman, Phelps & McNamara. The impact is also significant for lawyers. “Whenever a new rule comes out, it’s a good thing for people who specialize in that area for the law practice,” Siegner said. The rules address the gamut of manufacturing processes, including production, packaging, labeling and storage. They also outline requirements for quality-control procedures, design and construction of manufacturing plants and testing. Back-office rules govern record-keeping and handling of consumer complaints. The rules are effective on Aug. 24, but full compliance deadlines range from June 2008 to June 2010, depending on the company’s size. After several years of FDA meetings with industry and academia, the general consensus was that the dietary-supplement industry needed its own manufacturing rules because its system is substantially different than food manufacturing, said Vasilios Frankos, the FDA’s director of the division of dietary-supplement programs. “Publishing a specific rule is the best way to ensure quality,” Frankos said. Besides helping clients adopt the far-reaching rules, lawyers will be on hand to defend clients facing FDA enforcement action and tort claims triggered by the FDA’s warning letters to companies that fall short of compliance. Patton Boggs is receiving inquiries from both existing clients and potential new clients, particularly smaller companies facing a steeper learning curve, said Paul Rubin, an FDA practitioner at the Washington-based firm. “Many of the smaller companies may have more work to do to come into compliance,” Rubin said. A wide scope Larger companies that have been self-regulating in anticipation of eventual FDA rules also need help matching their existing programs with the new requirements, Siegner said. Every company is significantly affected, said Jim Jacobson, a Boston lawyer who co-chairs Holland & Knight’s national health law team. “There isn’t a supplement maker that isn’t going to have to go through an extensive review of their policies and procedures and compliance guidelines,” Jacobson said. The 208-page Federal Register listing contains numerous gray areas, and that’s where lawyers come in, Rubin said. “The entire regulation is going to lead to a significant number of questions from clients because many areas are not black and white,” Rubin said. “There are many areas and issues that require judgment calls. Our clients tend to call us in those situations.” Lawyers say the rules’ general instructions on how to take all necessary precautions to prevent contamination, using adequate lab facilities for the necessary testing and examination and scientifically valid testing methods leave lots of room for interpretation. Companies need lawyers to cut through the fog, Troy said. “Whenever you have hard, new and difficult questions, you’re going to have lawyers involved,” Troy said. The FDA’s Frankos said the rules are flexible because there are few scientific, peer-reviewed methods to analyze dietary supplement ingredients. “We felt we would give the flexibility [and] put on the shoulders of the manufacturers the requirement to develop the appropriate method and make sure it’s a scientifically valid method,” Frankos said. That flexibility ultimately means the FDA has great discretion to determine whether the companies are in compliance, Troy said. “Previously, dietary-supplement companies did not have cause to quake when an FDA inspector showed up at their door,” Troy said. “Now they do.” Rubin expects rigorous enforcement, both because of congressional and interest-group pressure on the agency, and because of the FDA’s own investment in the regulations. “Having spent this much time developing good manufacturing practices regulations, the FDA is sure to institute an enforcement program,” he said. FDA’s Frankos said the agency always conducts random inspections and companies with multiple adverse events could be subject to targeted inspections. Tort risk The new rules will also expand tort lawyers’ arsenals once the FDA starts issuing warning letters about dietary-supplement companies and producing inspection reports. Plaintiffs could point to warning letters and any negative reports about the company as signals of quality problems at the company, Rubin said. “If someone is going to sue a dietary-supplement company alleging the company had poor quality, they now have additional ammunition to point to,” Rubin said. FDA warning letters to pharmaceutical companies, which the agency posts on its Web site, have frequently triggered lawsuits against that industry, Troy said. FDA warning letters to dietary-supplement companies will also be available online. Inspection reports will be publicly available through the Freedom of Information Act public disclosure laws. “When a company gets a warning letter, there’s often litigation that follows in its wake,” Troy said. The regulations don’t create a new cause of action, but the processes outlined in the regulations are a blueprint for plaintiffs’ lawyers if a supplement user is injured or hospitalized by the company’s products, Jacobson said. Even scrupulous companies that strive for compliance get warning letters, Troy noted. “Complying is no small task,” Troy said. “You have to have written procedures for almost everything and have to document almost everything. It really is a complete reorientation of your entire manufacturing process.”

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