What is in this article?:
- What drives FDA to seize dietary supplements
- Is your company susceptible to product seizure?
FDA's not just sticking to warning letters anymore. Compliance is crucial and so is how a company reacts to a warning letter. An FDA expert explains what FDA watches for when it comes to dietary supplements compliance.
Yesterday, U.S. Marshalls seized UAS Laboratories' DDS line of probiotic products because of disease claims declared on the labels, according to the U.S. Food and Drug Administration (FDA). This latest product confiscation by FDA is one of many as the agency becomes more willing to conclude years of a dietary supplement company's regulatory missteps.
FDA said that Minnesota-based UAS Laboratories claimed the DDS probiotics "could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers and high cholesterol." Under the Federal Food, Drug, and Cosmetic Act only drugs, not dietary supplements, can be marketed with disease claims. The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior and Cran-Gyn DDS in capsules, powders and tablets.
On Monday, U.S. Marshalls seized another dietary supplement because it was unapproved and misbranded as a drug. Kansas-based Wyldewood Cellars elderberry juice products claimed to cure, treat or prevent various disease conditions, such as AIDS, diabetes and flu.
Product seizures a long time coming?
Both UAS Labs and Wyldewood Cellars received warning letters, but FDA follow-up inspections revealed the violations were ongoing.
"You're looking at the culmination of two years of increased enforcement action," said Jason Sapsin, lead attorney for Polsinelli Shughart's FDA practice. "It takes a while for non-emergency enforcement actions to percolate up through the system." Sapsin said the FDA has been working with UAS Labs since 2009 and Wyldewood since 2006.
"The FDA is committed to protecting consumers from unapproved products on the market," said Dara Corrigan, FDA's associate commissioner for regulatory affairs. "We will continue to take actions against companies that do not meet federal standards for safety, effectiveness and quality."
The NewHope360 article about the elderberry product seizure gathered mixed comments. One anonymous commenter defended elderberry, stating that the FDA should focus on all the junk in the market. Another anonymous commenter replied, "The FDA is in charge of making sure companies don't make claims about curing desease [sic] unless they can prove it. That's all they did here, they gave the company a chance to remove their claim or produce studies to prove their claims. The company failed."