Ultra Botanicals Recalls MSM Eye/Nasal Drops for Contamination, Drug Status

July 16, 2001

2 Min Read
Ultra Botanicals Recalls MSM Eye/Nasal Drops for Contamination, Drug Status

WASHINGTON--Ultra Botanicals Inc., based in Los Angeles, has stopped selling all 1-oz. bottles of Ultra Botanicals MSM Eye Drops and All That's Natural MSM Eyes & Nasal Drops. The Food and Drug Administration (FDA) stated in a July 11 press release that "the lack of evidence demonstrating the safety of MSM [methylsulfonylmethane] for use in the eyes or nose" was one reason behind the company-backed recall.

According to an FDA spokesperson, nasal and eye drops, depending on how they are labeled, are classified as cosmetics. However, when some ingredients--such as MSM--are added to these types of products, they are classified as drugs. "These drops would not be regulated as supplements, since they're not ingested," FDA stated.

Another aspect of the recall included "sight-threatening" bacteria that had contaminated certain samples of the two products. FDA found the contamination after testing several batches (including one that was quarantined) of the drops. Even though the agency did not say from which batches these products originated, the company stated that it is reasonable to assume they were from the quarantined batch.

When FDA expressed concern to Ultra Botanicals about the MSM eye and nasal drops, the company pulled the products from retail shelves. "Evidently, FDA has jurisdiction on anything that goes into the eyes and the nose," said Bill Lockton, national sales manager for Ultra Botanicals. "Because these products weren't approved for use in the nose or the eyes by FDA, we had to stop using them."

According to Lockton, FDA was surprised when the company recalled all of the drops, because it had not asked for a blanket recall. "They just told us we couldn't sell them anymore," Lockton stated. "But we felt that if FDA didn't feel that they were appropriate products to sell in the marketplace, we should just take them off the shelves and credit our customers."

Over the last two years, the company said it has sold 60,000 units of these two MSM products. However, it added there have been no reported injuries in connection with these products. Consumers who have questions can call (800) 357-7655.

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