Not an Empty Threat; Recent FDA Seizure Actions Follow Warning Letters to a Dietary Supplement Distributor and a Winery

June 12, 2011

By Riëtte van Laack

Recent FDA enforcement actions suggest that FDA will diligently pursue companies that have received Warning Letters for certain violations – and that have allegedly failed to clean up their act.

U.S. Marshals recently seized product from UAS Laboratories (“UAS”), a probiotics dietary supplement distributor (see here), and Wyldewood Cellars (“Wyldewood”), a winery, marketing elderberry juice concentrate (see here). Both companies had previously received Warning Letters that claims for their products caused the products to be illegal drug products.

In 2005, FDA issued a Warning Letter to UAS stating that claims for its probiotic supplements that the products prevented diseases, including cold, flu, and yeast infections, caused the products to be illegal drug products. According to the recent Complaint, a 2007 inspection showed that UAS did remove the identified claims from its website.  However, during a March 2011 inspection, FDA allegedly learned that the UAS website again included disease claims for the products.  When, as recently as May 14, 2011, these claims had not been removed, FDA filed a Complaint for Seizure of the products.  UAS filed an answer to FDA’s Complaint denying that its products are drugs and asserting the affirmative defense that FDA’s claim is barred by the doctrines of laches, estoppel and waiver.

Wyldewood received a Warning Letter in 2006 informing the company that therapeutic claims on the label and website for elderberry juice concentrate, including claims that it may prevent colds and flus, caused the product to be an illegal new drug. FDA claims that, although the company committed to removing the offending claims, an FDA inspection in 2011 showed that Wyldewood continued to use similar claims.  Subsequently, FDA filed its Complaint for Seizure of the elderberry juice concentrate.

These two seizure actions send a strong message that FDA may well follow up on Warning Letters for certain violations.  Moreover, even if an alleged offending company brings its products in compliance, the company may be subject to increased scrutiny and more frequent inspections.  Although seizure is a somewhat cumbersome enforcement mechanism, the standard paragraph in Warning Letters regarding FDA’s enforcement powers should not be interpreted as an empty threat.  As evidenced by these recent actions, the Agency can use its seizure authority, even when there is no imminent threat to public health or safety.  FDA may well make similar use of its enhanced administrative enforcement authorities under the FDA Food Safety Modernization Act once those authorities are fully implemented.