2011 FDA Warning Letter Review: The Rise of GMPs

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Related tags: Dietary supplement

2011 saw a sharp rise in cGMP-related FDA warning letters
2011 saw a sharp rise in cGMP-related FDA warning letters
GMP violations dominated dietary supplement warning letters issued by the Food and Drug Administration in 2011, from failure to establish product specifications to poor record keeping, reveal FDA legal specialists Ivan Wasserman and La Toya Sutton.

In 2010, we saw the first warning letters for dietary supplement current Good Manufacturing Practices (GMP) violations. In 2011, the number of GMP related letters soared, representing half of the total warning letters issued by the agency.

In our annual review, we identified a total of 68 warning letters concerning dietary supplement products in 2011:

GMP Violations Dominate

In 2010, FDA issued 8 letters regarding GMP violations. In 2011, that number quadrupled, with 34 companies being cited for a wide range of violations – from failure to establish product specifications to failure to maintain adequate records.

Peeling Back Labels

Along with the rise in GMP violations, 2011 saw a rise in citations related to labels. In 2010, our review found 7 letters referring to technical labeling errors and 10 regarding claims made on labels and labeling. In 2011, those numbers rose to 17 and 25, respectively. This increase may be attributable to label reviews being a component of GMP inspections.

Warning Letter Activity Fluctuates From Year to Year

According to our data, the number of warning letters issued in the past four years has shown great fluctuation. In 2008 there were 44 (blue bar), in 2009 there were 73 (red), in 2010 there were 41 (yellow) and in 2011 there were 68 (green):

H1N What?

As could be expected, claims related to 2009’s hot button health issue has faded to zero. No supplements involving H1N1 claims were the target of warning letters in 2011. However, letters regarding claims about the common cold remained relatively stable – 9 letters were issued in 2011, in comparison to 7 in 2010.

What is a warning letter?

The agency sends warning letters to manufacturers or marketers to inform them of violations of FDA laws and regulations. FDA may observe violations during an inspection of manufacturing or other facilities, or when otherwise reviewing product labeling, including claims made on web sites.

A primary area of FDA’s focus for dietary supplements is the distinction between permissible ‘structure/function’ claims and unlawful ‘disease’ or ‘drug’ claims - i.e. claims that state or imply the product will treat, cure, or prevent a disease.

Ivan Wasserman is a partner, and La Toya Sutton is an associate, at Manatt Phelps & Phillips in Washington, DC. They specialize in advertising and labeling issues for the food and dietary supplement sectors.

Related topics: Regulation, GMPs, QA & QC

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