Natural Products Insider

MAR-APR 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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54 INSIDER March/April 2018 Contract Manufacturing Regulations concerning the manufacture, packaging, holding and distribution of dietary supplements have been in effect for over a decade. They are codifi ed in the Code of Federal Regulations (CFR), part 111 cGMPs (current good manufacturing practices), the "DS CGMP Rule." Every step along the supply chain is covered by these regulations, and the emphasis on compliance with these regulations has never been more important. Contract manufacturers have the greatest burden regarding the application and enforcement of these regulations, in large part because of the amount of involvement. The activities involved in co-packing products on behalf of another company are no less detailed, and the obligations out of these regulations are being reinforced through greater efforts on the part of FDA. The result of this reinforcement is the establishment of a new normal for the regulated. Inspections that occur with increasing frequency by representatives of FDA (sometimes inclusive of state regulatory agencies serving as surrogates for these inspections) involve deeper analysis of practices being employed. Defi ciencies found during inspection are recorded on an inspectional observations sheet (form 483) and response detailing actions to be taken is required. Failure to respond appropriately, inclusive of actual implementation of corrective actions described in the response, can result in the issuance of a warning letter. This is effectively the potential for "strike two" in the regulatory at bat. Now, there is a shift in the norm. In part as the result of authority granted to FDA by the Food Safety Modernization Act (FSMA), FDA is increasingly acting in a direct fashion after a second strike. The actions taken now involve enlisting the power and authority of the U.S. Department of Justice (DOJ) to mete out punishment for lack of compliance. This is usually a self-accepted punishment in the form of a consent decree. The terms of the decrees can effectively relegate a business to the ash-heap of history and prevent the current owners from participating in the industry in the future. This is a real threat and is part of the normal consequences of non-compliance. The application of FDA's administrative authority is a response to the history of recalcitrance on the part of some industry members (remember that decade that has passed since fi nalization of GMPs?). The • 410-754-8141 • Visit us at SupplySide East Booth# F143 Fulfillment Service Inc. SISK Scan for more details & contact us today. • • NSF cGMP COMPLIANCE • TEMPERATURE & HUMIDITY CONTROL • RETURNS MANAGEMENT • HIGH VOLUME ORDER CAPACITY • SAME DAY ORDER FULFILLMENT • LOT # AND EXPIRATION DATE CONTROL Regulatory Enforcement in Contract Manufacturing: An Emerging Normal by Jim Lassiter

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