FDA Says O.C. Firm’s Supplement Makes Drug Claims


Federal regulators have notified Wakunaga of America Co., a Mission Viejo manufacturer of dietary supplements, that it is making inappropriate medical claims for a product it’s selling as an intestinal aid.

In a June 18 letter, the Food and Drug Administration said the company’s labeling for its product, Probiata, indicates it’s “intended to treat, prevent or mitigate ‘disorders such as diarrhea, constipation and yeast discomfort caused by antibiotic usage’ "--which amount to claims that apply to drugs rather than dietary supplements.

The agency’s letter reiterates statements previously made in a May 22 letter to Wakunaga’s president, and it directs the company to submit its claims to drug regulators. Drug laws require a company to prove a product is safe and effective before it can be sold.

Mitsuru Takiura, Wakunaga’s president, said the company believes it made appropriate “functional” claims for the product because “we are talking about the function of the intestine.”


However, after correspondence with the agency, he said, the company is now reviewing how it might best “express or restate” its claim.

Agency officials estimated that it has issued such “courtesy” letters to supplement manufacturers on 40 objectionable claims since Congress passed the Dietary Supplement Health and Education Act of 1994. Five California companies have received such notices.

Still, the agency hasn’t taken any regulatory actions against the companies, such as demanding that they change their labeling or having their product seized, officials say. The agency awaits direction from a presidential commission regarding how the 1994 law should be implemented.

On Tuesday, the Presidential Commission on Dietary Supplement Labels issued a draft report that included a recommendation that the FDA step up its enforcement actions. The commission’s final recommendations are expected this fall.


Takiura said Wakunaga did its best to meet regulators’ expectations when it initially crafted labeling for Probiata but lacked guidance because the agency has yet to establish its policies under the 1994 law.

“We were shooting in the dark,” he said.

The product, composed of “friendly” acidophilus bacteria, has been used safely for many years in Japan and Europe, and the bacteria are commonly found in yogurt, he said.

The agency began issuing such notices in the wake of the 1994 law, which made a distinction between products sold to treat or prevent disease--commonly called drugs--and those used to support a body’s structure or function.

The law allowed makers of dietary supplements, including herbal remedies, minerals, vitamins and amino acids, to make claims that their products affect a body’s structure or function.

Products claiming to treat, mitigate or prevent disease are considered drugs, which must pass stringent regulatory tests on safety and effectiveness.