GMPs and the NBA
Since blogs are supposed to be topical this one fits right in. As I write this we are deep in the midst of the NBA Playoffs. As I was reviewing some of the action and the outcomes a thought struck me concerning the similarity between the NBA and the Dietary Supplement Industry. Specifically the new GMPs for Dietary Supplements. Now it may not be immediately obvious but there is a significant similarity that should be noted and perhaps this sports analogy will get the members of the industry aware of what is coming.
This June the NBA playoffs will conclude but the full-court coverage of the FDA’s enforcement action on companies manufacturing dietary supplements goes into full effect. While this is a nice segue into the topic it is not the heart of the matter. Here comes the reality when the enforcement actions begin. Let’s look at the NBA for a minute. The game has rules and when those rules are violated, penalties are assessed. This can range from taking the ball out of bounds through free throws through ejections from the game and even additional suspensions and fines. Well, the FDA acts as a referee in determining the “fouls” assessed individual companies when they are inspected for GMP compliance. These fouls can be an issuance of a report listing the deficiencies all the way to closing the doors of your operation and assessing heavy fines. Sure a bit of an analogous stretch but here is where the real similarity exists.
In the NBA one of the most controversial aspects of the referee’s job during these playoffs has been the assessment of “flagrant fouls.” There are multiple categories of these flagrant fouls and the assignment of category resides with the referee. The difference in categories is significant relative to whether a key player is ejected or perhaps even suspended. The controversy comes in where the referee has to make these judgments regarding the intentions and actions of the players. When it comes to the GMPs for Dietary Supplements, the same holds true. The FDA issued the Final Rule and touted loudly the “flexibility” you have as a manufacturer to achieve compliance. What is not openly stated in the regulations nor in the preamble to the regulations is the fact that the interpretation of whether you are in compliance is strictly up to the inspector (akin to the referee). The inspector has the authority to assess and make judgments as to the efforts you have made are sufficient to meet the requirements of the regulation. This is the other edge of the sword of flexibility. You may feel confident that you have taken steps to insure that the batch records, for instance, are complete and have the appropriate signatures as well as reflecting the points in the process where control is necessary. The inspector need not see it this way at all. Their interpretation of the regulation is going to likely vary from day to day, inspector to inspector and even company to company. Inspection guidances are forthcoming from FDA for their personnel to assist in this effort but in their absence you are hoping to succeed in compliance rather than being assured if you don’t take the extra steps necessary. Then when the Guidance Documents come out – will you know about them.
The Dietary Supplement GMPs are intended to be of great benefit to the consumer in insuring the safety and consistency of the products they buy while further assuring the consumer that they are getting what they are paying for. The implementation of this regulation though means that you have some work to do and June is just around the corner. Before you are cited for a “flagrant foul” and have to pay a price far greater than a free throw – seek professional help. The resources are out there and you should insure that the interpretation is kept to a minimum.
JL
Ingredient Identity - www.ingredientidentity.com
This June the NBA playoffs will conclude but the full-court coverage of the FDA’s enforcement action on companies manufacturing dietary supplements goes into full effect. While this is a nice segue into the topic it is not the heart of the matter. Here comes the reality when the enforcement actions begin. Let’s look at the NBA for a minute. The game has rules and when those rules are violated, penalties are assessed. This can range from taking the ball out of bounds through free throws through ejections from the game and even additional suspensions and fines. Well, the FDA acts as a referee in determining the “fouls” assessed individual companies when they are inspected for GMP compliance. These fouls can be an issuance of a report listing the deficiencies all the way to closing the doors of your operation and assessing heavy fines. Sure a bit of an analogous stretch but here is where the real similarity exists.
In the NBA one of the most controversial aspects of the referee’s job during these playoffs has been the assessment of “flagrant fouls.” There are multiple categories of these flagrant fouls and the assignment of category resides with the referee. The difference in categories is significant relative to whether a key player is ejected or perhaps even suspended. The controversy comes in where the referee has to make these judgments regarding the intentions and actions of the players. When it comes to the GMPs for Dietary Supplements, the same holds true. The FDA issued the Final Rule and touted loudly the “flexibility” you have as a manufacturer to achieve compliance. What is not openly stated in the regulations nor in the preamble to the regulations is the fact that the interpretation of whether you are in compliance is strictly up to the inspector (akin to the referee). The inspector has the authority to assess and make judgments as to the efforts you have made are sufficient to meet the requirements of the regulation. This is the other edge of the sword of flexibility. You may feel confident that you have taken steps to insure that the batch records, for instance, are complete and have the appropriate signatures as well as reflecting the points in the process where control is necessary. The inspector need not see it this way at all. Their interpretation of the regulation is going to likely vary from day to day, inspector to inspector and even company to company. Inspection guidances are forthcoming from FDA for their personnel to assist in this effort but in their absence you are hoping to succeed in compliance rather than being assured if you don’t take the extra steps necessary. Then when the Guidance Documents come out – will you know about them.
The Dietary Supplement GMPs are intended to be of great benefit to the consumer in insuring the safety and consistency of the products they buy while further assuring the consumer that they are getting what they are paying for. The implementation of this regulation though means that you have some work to do and June is just around the corner. Before you are cited for a “flagrant foul” and have to pay a price far greater than a free throw – seek professional help. The resources are out there and you should insure that the interpretation is kept to a minimum.
JL
Ingredient Identity - www.ingredientidentity.com
Posted by Jim Lassiter at 5/14/2009 8:13 PM 
Categories: Regulatory Need to Know's
Tags: FDA Rule Dietary Supplement Ingredient Identity Guidance GMP Safety
Categories: Regulatory Need to Know's
Tags: FDA Rule Dietary Supplement Ingredient Identity Guidance GMP Safety
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