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The hidden danger hiding in your toiletries
"Toxmetics." That's what cosmetics should be called, according to US physician Dr William Campbell Douglass II.
Recalls of FDA-Regulated Products -What You Need to Know The current recall of peanut products due to potential salmonella contamination is poised to become the largest in history. Affecting over one hundred food manufacturers who sourced peanut-derived ingredients from the Peanut Corporation of America (PCA) and many hundreds of finished products, the recall likely will cost the food industry hundreds of millions of dollars. Federal authorities have begun a criminal investigation of PCA, and Congressional leaders and consumer advocacy groups are calling for greater oversight of the entities that manufacture and handle our food. This latest crisis follows in the wake of an unprecedented spate of product recalls in the last few years. Hundreds of dog and cat food products were recalled due to melamine contamination, and over 21.7 million pounds of ground beef were recalled due to E. coli contamination, causing a 67-year-old meat processor to close its doors. Contamination of the drug heparin led to a major recall, and medical device manufacturers also have had to recall products due to reports of adverse events and device malfunctions. These high-profile product recalls have highlighted the need for corporations to be prepared to deal with a recall situation before disaster strikes. The need to recall one or more products can and frequently does arise at the worst possible time, and when that happens, difficult decisions must be made quickly to reduce potential injury to consumers, disruption to the supply chain, and damage to the corporation's business and reputation. Decisions made in the early hours after a corporation learns it has a potential recall can determine whether a recall leads to major damage to the business and whether a wave of litigation follows. Poorly-made decisions at that point can lead to significant, even criminal, liability. A Recall Plan - All manufacturers need to have a recall plan in place before the need for a recall arises. The regulations in 21 C.F.R. §§ 7.40-7.59 can provide valuable guidance, as can the United States Food and Drug Administration (FDA) Guidance For Industry - Product Recalls, Including Removals and Corrections, available at http://www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm. If the manufacturer or distributor has no experience writing recall plans or conducting recalls, the plan should be reviewed by experienced regulatory counsel to make sure it is complete and appropriate. If the manufacturer produces infant formula, medical devices or human biological products, the plan must address the fact that FDA has authority to mandate recalls of these products in certain cases. Health Hazard Evaluation and Determining the Level and Depth of the Recall The first step in determining how to address the potential recall issue requires the company to make a health hazard evaluation. That assessment will direct the classification of the recall and the overall approach both the company and FDA will take. FDA divides recalls into three classes: Class I (in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death); Class II (in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote); and Class III (in which use of or exposure to a violative product is not likely to cause adverse health consequences). Therefore, a company must first perform the health hazard analysis before it can classify the recall. Determining the level of the recall frequently will also dictate the depth of the recall, i.e., whether it is conducted back to the distributor/warehouse level, the retail level, or the consumer level.
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