2010 FDA warning letter review: The decline of H1N1 and the rise of GMPs

By Ivan Wasserman and La Toya Sutton

- Last updated on GMT

Related tags: Dietary supplement, Fda

2010 saw the first warning letters from the US Food and Drug Administration (FDA) for supplement Good Manufacturing Practices (GMP) violations, but the overall numbers were down on 2009 levels. FDA legal specialists Ivan Wasserman and La Toya Sutton look back on 2010, the rise of GMPs and the decline in the threat of H1N1.

In 2009, the US Food and Drug Administration (FDA) issued 73 Warning Letters involving dietary supplement products with a clear focus on the marketing of illegal swine flu (H1N1) products. In 2010, FDA issued 41, reflecting a decline in H1N1-related warning letters corresponding to the decline in public concern about the virus. Also 2010 saw the first warning letters for supplement Good Manufacturing Practices (GMP) violations.

Our review identified a total of 41 warning letters concerning dietary supplement products in 2010.

Target of Letter

Number of Letters

'Drug/Disease' claims

36

Heart Disease/cardiovascular claims

13

Diabetes claims

9

H1N1 claims

5

Cold/Flu (other than H1N1) Claims

7

Arthritis/Joint

9

Cancer claims

13

Weight Loss

5

Other “drug/disease” claims

27

Tainted products

1

Claims concerning “FDA approval”

1

GMP violations

8

Technical labeling errors

7

Claims made on labels and labeling

10

Claims made on websites

31

Claims made in metatags

5

Claims made in broadcast or print advertising

0

H1N1 Fades

Many of 2009’s warnings letters (37 out of 73) were issued to companies making H1N1 claims about their dietary supplements – a hot issue and a high-priority for the FDA at the time. In 2010, that number dropped to 5.

GMP Violations

With the dietary supplements GMPs in full effect, this year FDA issued 8 letters concerning GMP violations. This number is likely to rise as the number of inspections increase.

Relatively Consistent Volume

Taking out all of the H1N1-related letters (there were 5 in 2010), our three-year data shows some consistency in number of dietary supplement warning letters:

2008: 44

2009: 36

2010: 36

Web sites still a focus

As with previous years, the majority of the Warning Letters in 2010 involved claims made on web sites. FDA can consider any statement or claim that appears on dietary supplement web pages to be a labeling claim for the product, including claims made in metatags.

No Hot Button Health Issue

Aside from the increase in GMP-related Warning Letters, this year shows a certain amount of evenness across the board. While Warning Letters for cancer and other disease claims still lead the field, as they have in the past, no one category of products stands out as representative of FDA’s focus this year.

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 labelling, 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, Product claims

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2 comments

2010 FDA warning letter review

Posted by Claudette Sutton,

I am happy that people are attempting these studies to educate us about these dangers in dietary supplements. Hopefully something will be done to decrease these GMP violations.

Congratulations to you and your boss.

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GMP Violations

Posted by Karen McCray,

Thank you for informing me about the dangers hidden in dietary suppplements. This is very important information. It really must have taken you a great deal of time and energy to complete this three year study. Must efforts like these go unmentioned and unappreciated. I just want to say thank you.

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