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New standards for dietary supplements proposed
On March 7, the Food and Drug Administration proposed to require current good manufacturing practices in the manufacturing, packing, and holding of dietary supplements. The proposed rule would, for the first time, establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled to accurately to reflect the active ingredients and other ingredients in the product. It includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. Details are in the Federal Register of March 13 (68 FR 12157-12263). For more information, see the FDA Factsheet at www.fda.gov/bbs/topics/NEWS/dietarysupp/factsheet.html.
Increased X-ray levels requested
Ion Beam Applications has asked FDA to amend the food additive regulations to increase the maximum permitted energy level of X-rays for treating food to 7.5 million electron volts (MeV) from the currently permitted maximum level of 5.0 MeV. Details are in the Federal Register of March 13 (68 FR 12087-12088).
Tougher regulations for genetically engineered plants
On March 10, the U.S. Dept. of Agriculture’s Animal and Plant Health Inspection Service announced that it is strengthening the permit conditions to field-test plants genetically engineered to produce pharmaceutical and industrial compounds. The new requirements will be applied to the 2003 growing season. The agency is also seeking public comment on ways to improve specific aspects of its program. Details are in the Federal Register of March 10 (68 FR 11337-11340).
Ephedrine alkaloids comment period reopened
FDA is reopening for 30 days the comment period for a proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids” that was published in the Federal Register of June 4, 1997 (62 FR 30678). In that document, FDA proposed a number of requirements relating to dietary supplements containing ephedrine alkaloids, including a requirement for a warning statement on the product label. Since publication of the June 1997 proposal, new scientific evidence has come to light concerning health risks associated with the use of dietary supplements containing ephedrine alkaloids. Details are in the Federal Register of March 5 (68 FR 10417-10420).
FSIS introduces new AMR products testing
USDA’s Food Safety and Inspection Service announced on March 3 a regulatory sampling program to ensure that beef products derived from Advanced Meat Recovery (AMR) systems are accurately labeled. AMR is a technology that removes muscle tissue from beef carcasses without breaking bones. When produced properly, AMR product can be labeled as “meat.” Previously, FSIS inspectors took regulatory samples of AMR product if they believed that an establishment was not completely removing spinal cord tissue. Products labeled as “meat” found to contain spinal cord tissue are considered misbranded. On March 3, FSIS began a routine regulatory sampling of beef products from AMR systems as outlined in a December directive. The new sampling program requires inspectors to test beef product from AMR systems on a routine basis to verify that spinal cord tissue is not present. More information on AMR systems and the new sampling program can be accessed online at www.fsis.usda.gov.
FDA allows use of vitamin D3 in fruit juice
FDA is allowing use of vitamin D3 as a nutrient supplement in calcium-fortified fruit juices and juice drinks, excluding drinks specially formulated for infants, at levels not to exceed 100 International Units per reference amount customarily consumed. This action is in response to a petition filed by The Minute Maid Co. Details are in the Federal Register of February 27 (68 FR 9000- 9003).
FDA amends bottled water standards
FDA is amending its bottled water quality standard regulations by establishing an allowable level for the contaminant uranium. Bottled water manufacturers are required to monitor their finished bottled water products for uranium at least once each year under the current good manufacturing practice regulations for bottled water. Details are in the Federal Register of March 3 (68 FR 9873-9882).
by JAMES GIESE