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1998 FDLI Update 1 (1998)

handle is hein.journals/fdliup1998 and id is 1 raw text is: A E!.DLi Update, A Newsletter of The Food and Drug Law Institute Issue 1 * 1998 Proposition 65-Action Against Fish Oil May Set New Standards for Impurities in Foods Carol Ren Brophy California's Proposition 65 requires manufac- turers, distributors, and us- ers of consumer and com- mercial products to provide warnings to individuals ex- posed to any detectable amount of approximately 600 listed chemicals, or to prove in an enforcement ac- tion that a warning is not re- Carol Rc quired.1 FDA-regulated products are not exempt from Proposition 65, but imple- menting regulations do establish an ex- emption for chemicals that are naturally occurring in a food or in products derived from a food.' Under this provision, a company must demon- strate that the chemical in question is naturally oc- curring in a food or a food ingredient; the chemical's presence cannot be reduced or avoided by good manu- Broph- facturing practices; and the company has used quality control pro- cedures that reduce the level of the chemical to the lowest level currently feasible. As explained in the second article in this series, application of the naturally occurring exemption by the Attorney Gen- eral and Proposition 65 bounty-hunters threatens to narrow this exemption sig- nificantly.3 In a settlement agreement in the so-called Calcium Cases (a series of Proposition 65 cases alleging that cal- cium supplements contain excessive lev- els of lead), the Attorney General re- quired manufacturers of calcium supplements to use the source of calcium with the lowest level of the Proposition 65-listed chemical present, regardless of Continued on page 2 FDA's Chief Counsel Reviews the Year at Develop and Implement Policies and Procedures for Conducting R ecalls ...................................... 3 Pharmacovigilance: Managing R isks .......................................... . 4 Food Safety Initiatives-Current and Future FDA Policies ................... 5 FDLI Tests the Internet as a New Educational Medium .................. 8 What you Need to Know About Food Product Recalls .................. 9 Have an Idea for an Educational Program in Your Area? .............. 11 Planning FDLI's 50th A nniversary .............................. 15 FDLI Lawyers' Luncheon A s is traditional, we use this occasion to mention the legal high- lights of the past year at FDA and anticipate pos- sible trends for the fu- ture. Last year at this time the agency had issued fi- nal regulations and ac- companying jurisdic- AlargIel . tional analysis restricting the access and appeal of cigarettes and smokeless to- bacco to children and adolescents, and the agency was briefing the major legal issues before the district court. Since then, FDA received a favorable decision from the district court in North Caro- lina that upheld the agency's jurisdic- Margaret Jane Porter tion over these products and the access and labeling provi- sions of its regulations, but re- jected the agency's use of the restricted device authority in the proposed advertising re- strictions. All parties have ap- pealed and the issues have been briefed and argued before Port the Fourth Circuit. Mean- while, the agency is proceed- ing with implementation of those por- tions of the regulations that are in effect. In addition to the extensive negotia- tions on the FDA Modernization Act and its implementation, the agency has been active on the litigation front. Enforce- ment priorities have ranged from con- Continued on page 3 Digitized from Best Copy Available FDLI . .. a non-profit institute dedicated to advancing the public health by providing a neutral forum for critical examination of the laws, regulations, and policies related to drugs, medical devices, other health-care technologies, and foods.

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