Ashish Talati, Partner

June 21, 2013

2 Min Read
Five Ways Manufacturers Can Avoid Running Afoul of FDA or FTC

1.) Ensure compliance with GMPs

With a recent increase in enforcement related to GMPs, it is imperative that manufacturers understand the GMP requirements and implement effective quality systems. Common issues identified by FDA with respect to GMPs include the absence of written procedures for quality control, the absence of product specifications, batch records and master manufacturing records, and improper documentation and document retention practices. Working with a GMP expert can be advantageous and can help avoid GMP-related enforcement issues. 

2.  Establish strategies for addressing inspections, enforcement actions and other compliance Issues such as recalls on both the federal and state levels

Companies should develop Standard Operating Procedures (SOPs) to address inspections, enforcement and other compliance issues. Having a pre-established procedure for addressing compliance issues can ease the inspection process, can help avoid further enforcement activity, and can ensure that compliance initiatives such as recalls are completed efficiently. Advanced preparation is the key.

3.  Understand the types of claims that can Be made and the level of support needed to substantiate product claims

FDAs enforcement is also focused on product claims and FDA works closely with FTC. It is important that companies fully understand the types of claims that can be and cannot be made for their products.  Additionally, it is equally important to understand that all product claims must be substantiated by competent and reliable scientific evidence. Both FDA and FTC are increasingly active in enforcement related to product claims, with FDA regularly issuing warning letters for disease claims and FTC pursuing monetary fines for unsubstantiated product claims.

4.  Keep abreast of changes in regulations that pertain to your company

FDA regulations are often confusing and are seldom in black and white. A valuable tool in understanding FDAs stance on many of its regulations lies in the warning letters which are available on FDAs website. From these warning letters, companies can grasp the regulations FDA is seeking to enforce and the types of activities FDA believes to be in violation of the federal Food, Drug and Cosmetic Act. Similarly, guidance documents also provide valuable insight regarding many of the regulations.

5.  The importance of due diligence and risk management

Performing due diligence reviews is an essential tool for ensuring sustainability for your company. During such a review a company can evaluate the regulatory status of its products and the possible regulatory pathways involved as well as evaluate the types of risks associated with the companys activities. Often these due diligence reviews involve consultation with experts within the industry and can help identify and anticipate any regulatory issues and compliance shortcomings so you can avoid the pitfalls.

About the Author(s)

Ashish Talati

Partner, Amin Talati Wasserman LLP

Ashish Talati is a partner with Amin Talati Wasserman LLP. He primarily counsels clients on matters of regulatory compliance, helping them anticipate and address regulatory issues in their day-to-day business operations and strategic planning. He is considered a leading authority in the areas of generally recognized as safe (GRAS) requirements and new dietary ingredients.

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