Glen Burnie, MD (PRWEB) July 11, 2012
FDA consulting firm, FDAImports.com, has won another substantial victory for a client on FDA Import Alert, this time for Import Alert 53-17, Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination. A Chinese company bringing in eye shadow to the United States found themselves on this import alert when their shipment was stopped at a U.S. port. The charge stated that the product appeared to “contain a poisonous or deleterious substance which may render it injurious to health.” The company contacted FDAImports.com to resolve this confusing issue. The problem? An internal FDA communications breakdown caused FDA to detain the entry, although the cosmetics contained no illegal microbiological contamination. Although this was a potentially simple diagnosis, it turned out to be a not-so-simple case to prove.
The Left Hand Knows Not…
The Bacteriological Analytical Manual (BAM) is the FDA’s “preferred laboratory procedures for microbiological analyses of foods and cosmetics.” In other words, it is the seminal resource for bacteriological standards and safety levels FDA uses for laboratory testing. In this case, the BAM set a tolerance level of 400 CFUs (Colony Forming Units) per gram for a cosmetic product intended for application in the eye-area. In the case of the Chinese company however, the CFU count was less than 100 CFUs per gram, in other words, not a danger at all. Yet FDA still detained the product and then placed the company on Import Alert 53-17. Why?
Benjamin England, Founder and CEO at FDAImports.com, believed this to be an example of the left hand of FDA research/science not knowing what the right hand of FDA enforcement/compliance was doing (and vice versa). In his opinion, the FDA’s enforcement/compliance arm came down hard on this particular company without acknowledging the correct tolerance level for bacteriological presence set forth in the BAM. The FDAImports.com team was able to diagnose this issue quickly and prepared a petition to remove the firm from Import Alert. The petition included not only the detailed explanation of the BAM tolerance for microbiological contaminants, but also a full regulatory review of the company’s operating procedures, SOP’s, quality controls and supply chain safety.
This two-pronged effort resulted in FDA removing the Chinese manufacturer of cosmetic ingredients from Import Alert 53-17, and also helped expedite the process, saving the company thousands of dollars in missed deadlines, additional testing, warehousing costs, and damaged reputation. The team at FDAImports.com has helped numerous clients from all over the world with removal from FDA Import Alert and, in the case of the Chinese cosmetics firm, has helped facilitate better quality controls, increased compliance, more accurate reporting and improved overall product safety as a result.
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact: Jon Barnes, (410) 220-2800 or pr(at)fdaimports.com.