'Jogging' drink seized, destroyed - Jogging in a Jug

FDA Consumer, Jan-Feb, 1996 by John Henkel

With a farmer's folksy charm, Jack McWilliams went into small towns across the country and told how a beverage he created had helped him conquer his own heart disease and arthritis. The news media in those towns ran prominently placed stories, and customers lined up to buy the drink--to the tune of $9 million in business a year.

But the government didn't buy it. By law, the product--a mixture of grape and apple juices and vinegar called Jogging in a Jug--was considered an unapproved new drug due to claims McWilliams, 64, made for it. Last July 18, FDA officials supervised the disposal of 13,320 half-gallon bottles of the juice, valued at $77,000. The federal government had seized the product on May 19, 1994, because of its unproven drug claims.

McWilliams, his son, Danny, and their firm, Third Option Laboratories of Muscle Shoals, Ala., signed a consent decree last May 17 in the U.S. District Court for the Northern District of Alabama. Under the terms of the decree, Third Option must alert its retail distributors of the court findings, including notification that the product cannot be "promoted, labeled, or advertised" in a way that makes unsubstantiated health claims.

The Federal Trade Commission, in a separate action, fined Third Option $480,000 after charging the firm with making false health claims. FTC also required Third Option to send all consumers who bought the product a letter informing them of the charges.

FDA first became aware of Jogging in a Jug shortly after the product debuted in the early 1990s. The agency received complaints about the product's claims from state regulatory agencies, local government of ficials, and consumers.

One of the company's main marketing strategies was to promote the product through the news media. McWilliams received coverage in newspapers and broadcast outlets.

"He would go into an area--usually a small community--and actually get the press, attention by holding a news conference touting an amazing new discovery," says Ray McCullough, a compliance officer in FDA's Nashville district office. "Then, instead of an ad in the inside pages, he,d end up with something better--a front-page article."

News stories about McWilliams, a dairy farmer, typically told of his discovery that vinegar had reduced pain and symptoms of his own heart disease and arthritis. He said taking vinegar could reduce the risk of cancer in the internal organs. He suggested that 2 ounces of his product a day could confer the same benefits.

Press accounts said that members of the last two generations of McWilliams, family had used vinegar regularly and lived into their 90s. In one article, McWilliams said that when pregnant women crave pickles, they really are craving acetic acid, the main ingredient in vinegar. McWilliams then used these press clippings as promotional literature.

In a warning letter dated March 27, 1992, FDA advised Third Option that marketing the drink accompanied by articles containing therapeutic claims violated food and drug law. Company representatives met with FDA in April 1992 and agreed to stop making the claims. But over the following months, FDA determined through complaints and reports that Third Option still was making unlawful claims. On May 19, 1994, federal marshals seized 13,320 bottles of the product, which remained stored for a year while FDA and the firm negotiated a consent decree.

Third Option Laboratories is still in business and is working with FDA on ways to market Jogging in a Jug legally.