Now foods and GMP Practices

Darrell Miller

02/04/10

Date: February 04, 2010 12:36 PM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Now foods and GMP Practices

Author: Michael Lelah, Ph.D, Technical Directory, Now Foods

It should come as no surprise that 2009 was a challenging year with regard to the timeliness of order delivery, not just at NOW, but on an industry-wide scale. Many of the brands you carry have not been able to meet your demands.

In 2009 all medium-sized dietary supplement manufacturers, including NOW Foods, were officially required to meet the FDA's new dietary supplement cGMPs (current good manufacturing practices). NOW has placed very high quality standards on our products, and has been certified by NPA's stringent GMPs since 2000. Now that the FDA has started auditing manufacturers in our industry, we have found that the FDA requirements for the cGMPs are more strict than the early interpretations of experts.

This has resulted in ourselves and our industry being less prepared than anticipated, affecting the order fulfillment rates of many companies. We are actively working to respond to this.

Let's review the new FDA cGMPs. Good Manufacturing Practices, or GMPs, are manufacturing control systems designed to ensure that health products are manufactured in a consistent and safe manner. Standard operating procedures, specifications for all ingredients and products, and lab testing are cornerstones of GMPs. The FDA cGMPs are considerably rigorous, and by the FDA's own estimates, 25% of the brands you carry could be out of business as a result of not being able to meet their new cGMPs. Moreover, even for reputable brands, there is a lack of clarity on what the FDA expects, as much of this is new.

You might be wondering what all of this has to do with your orders? We at NOW Foods, along with other reputable manufacturers have increased our quality control efforts to meet the new FDA cGMPs. There are more requirements for ingredients and finished products, more documentation and more testing. The breadth of NOW's product line requires testing of thousands of ingredients. Based on the extensive nature of these efforts, coupled with disruptions in the supply chain, your orders have most likely been affected.

We are now better prepared to serve you. We are taking the safety of our products to entirely new levels and doing everything in our power to expedite the delivery of NOW products to your door.

Here are just a few examples of what we're doing:

• We've implemented new systems and processes that meet the FDA's additional cGMP requirements
• We've developed a new state-of-the-art screening method for melamine, weight loss drugs, steroids and erectile dysfunction drugs. This is specifically designed to assure the safety of our products while retaining our commitment to natural.
• We've developed specialized methods to ensure the accurate identification of some ingredients that were once considered difficult-to-verify.
• We're expanding our industry-leading microbiology testing procedures and facilities to further improve consumer safety.
• We're working with our suppliers to minimize disruption to the supply chain
• We're implementing a new stringent Supplier Quality Verification program to further ensure the quality of our ingredients and raw materials.
• We're adding more manufacturing capacity, additional operators and technicians to meet increased demand as your business grows.
• We've improved our order fulfillment processes by upgrading our operations processes. This will better ensure that your orders arrive on time and complete.

Here's what you can expect from NOW Foods in 2010:

• Enhanced security and safety of products
• Improved delivery over 2009
• Even greater product quality
• Receive a higher percentage of complete orders over 2009
• Even higher service levels

At NOW Foods we are continuing to work hard to meet your needs, despite the increased challenges to our supply chain. We hope and anticipate that as we move into 2010, you will reap the benefits of our quality and fulfillment efforts.