What's in a Dietary Supplement Name? More Than Mere Semantics
Contributed by Rebecca Jones McKnight as part of our ongoing Dietary Supplements Matter series.
Ira Gershwin famously wrote: “You like potato and I like potahto, You like tomato and I like tomahto.”
In the case of “Amoxilina” and “amoxicillin,” Texas Attorney General Greg Abbott went to court to "call the whole thing off" under the Texas Deceptive Trade Practices - Consumer Protection Act.
On May 5, he obtained a TRO against Multimex Distributions Inc. and San Martin Distributing Inc. to stop the companies from marketing Amoxilina, a dietary supplement that the state said appeared to target the Hispanic community. “Amoxicillin” translates in Spanish to “amoxicilina.” The state said the product was also packaged to look like antibiotics, which are available over-the-counter in Mexico, unlike in the U.S. The TRO prohibits the companies from selling or distributing the product and orders them to immediately notify all retailers to whom the products have been supplied.
Abbott told the Austin American-Statesman that the product was “literally putting the lives of children at risk” and the products must be taken off the shelves.
In a press release issued May 6, Abbott stated that “[f]rom the product's name to its packaging, there was a clear attempt to confuse Texas families and mislead purchasers into thinking they were buying antibiotics.” As a result of the packaging claims, some Texas parents incorrectly believed they were giving their children antibiotics and ended up in the emergency room. According to one doctor’s affidavit, the product “could cause doctors to improperly evaluate and treat the children or conduct unnecessary medical procedures.”
On May 13, FDA issued a news release, warning consumers about this issue, both in English and Spanish. According to FDA, the problem is not limited to Texas: “The products have been distributed in Colorado, Delaware, Texas, Florida, California, Georgia, and potentially other markets. The products are marketed toward Hispanic consumers. They may be sold at various retailers, including small independent stores that cater to the Hispanic community.”
All dietary supplement companies should be cautious in marketing and branding efforts, to avoid statements, designs, or marketing strategies that the government could interpret as misleading consumers; FDA, FTC, consumer advocacy groups, and state attorneys general are all watching.
Please contact Kimberly K. Egan and Rebecca Jones McKnight for advice on these issues.
FDA has announced new regulations establishing current good manufacturing practices (cGMP) for dietary supplements. The regulations, issued on June 22, 2007, follow on last year’s Dietary Supplement and Non-Prescription Drug Consumer Protection Act, which, by the end of 2007, will require dietary supplement manufacturers, packers, and distributors to report all serious dietary supplement adverse events to FDA.
