The materials contained on this web site are for informational purposes only.  The information should not be considered legal advice and is not intended to create an attorney-client relationship. This web site contains general information and is not a substitute for legal advice from a qualified attorney licensed in the appropriate jurisdiction.

In late 1998, the Food and Drug Administration issued a warning letter to Sunrider following one of its inspections of Sunrider's manufacturing facility in the City of Industry, California. Many of you have seen the letter and are unsure what the letter means or why it is still on the Agency's website. The following explains the inspection and warning letter procedure, Sunrider's resolution of all issues raised in the letter, and our ongoing commitment to providing the highest quality products on the market.

All manufacturers of foods and drugs must periodically undergo testing by the FDA. The inspections are rigorous and thorough just as they should be. In fact, it is no exaggeration to say that FDA inspectors will find cause to issue a warning letter after every inspection they perform. For instance, even the large and reputable company Colgate Palmolive has been issued a warning letter following a recent inspection. This is not to imply that warning letters are so routine that they are not important. It simply illustrates that even large established companies will not likely escape a routine Agency inspection without a warning letter.

Here is how the inspection process works: Once an FDA inspector completes the inspection, areas of concern are documented on a form and discussed with the company's representative at the end of the inspection. The inspector then issues the warning letter describing the problems that must be addressed. Warning letters are issued even if the problems are relatively minor. However, to a third party, the tone of these warning letters may sound very ominous, particularly because many of the issues are highly technical and require a high degree of scientific knowledge. Also, because the FDA posts warning letters indefinitely it may erroneously appear that a company has not corrected the problems discussed in the letter. This is usually not the case. For instance, with Sunrider, all deficiencies were corrected to the FDA's satisfaction shortly after the inspection occurred. As an example, with VitaSpray^®, the Agency felt that if the directions called for the spray to be administered under the tongue, then the product was a drug instead of a dietary supplement. Although we disagreed, we changed our directions for use because it was simply not worth fighting over.

Sunrider has no other issues pending before the Agency because all were long ago resolved. We have asked the FDA to remove the warning letter but they advised us that all warning letters remain on the web site indefinitely. Although they acknowledge they have received numerous complaints from companies like Sunrider who have long since taken care the matters discussed in the warning letters, they still have not taken steps to remove these letters from their web site.

Please be assured that Sunrider views all inspections as an opportunity to improve its practices and procedures. Even when we disagree with the FDA's position on a particular matter, our staff works diligently with the inspector to make certain all problems are solved. Sunrider has always maintained a sound and professional working relationship with the FDA. We have confidence in everything we produce and can say to you with absolute assurance that you are consuming and selling only the highest quality products.