07.01.08
After making an appearance on the “Today Show” in late May, Jennifer Buettner and her husband, founders of a company called Efficacy Brands, were hurled into the spotlight for creating a product named Obecalp—from the word placebo spelled backwards. Most of the “Today Show” segment featuring the Buettners debated the ethics of using a placebo pill to treat children’s ailments. What piqued the interest of supplement makers, however, was the fact that the product is promoted as a dietary supplement. Daniel Fabricant, vice president of scientific and regulatory affairs, Natural Products Association, Washington, D.C., who was interviewed by the Tan Sheet about this product, said it is unlawful and that FTC would most likely remove it from the market on the basis of consumer fraud. Another expert quoted in a New York Times article called the product “inappropriate.” The same expert worried that regularly giving pills to children, whether inert sugar pills or drugs, might teach them that the cure to every ailment lies in a bottle.
On Obecalp’s website, Ms. Buettner talks about the reasons for launching the product. “I have a baby girl and two sons. One of them always needs my comfort and knowledge that I will make them feel better,” she said. “This is an example of the placebo effect. I invented Obecalp as the first standardized placebo. Ask your doctor about placebo. Trust his advice.” She goes on to say that while she believes in the miracle of modern medicine, she also believes it should only be dispensed when absolutely necessary.
But if this is a replacement for medicine—used to cure, treat, mitigate or prevent sickness—how can it still be called a dietary supplement? To that end, Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT, added, “The product is labeled as a dietary supplement but contains no dietary ingredients. This is a ‘pharmaceutical grade’ placebo, as opposed to a ‘food grade’ placebo? And this is a regular strength placebo. I can’t wait for the ‘extra strength’ version to be launched.”
Mr. Israelsen went on to point out other inconsistencies about the product. “This is the first standardized pharmaceutical inert placebo. I think we have a record here. This is a quintuple contradiction,” he said. “‘Pharmaceutically inert’ makes no sense. If it has no active ingredients, what are you standardizing against? The only thing missing here is ‘Doctor Recommended.’”
While not explicitly claiming to be a therapeutic agent, the point of a placebo is to treat an ailment, even if by deception. Therefore, this product, according to the bounds of the Dietary Supplement Health & Education Act (DSHEA), cannot be considered a dietary supplement. Mr. Israelsen elaborated on this point. “The whole notion of giving kids pills every time they throw a hissie fit is just all wrong and certainly not how the natural health community would approach a crying baby (or crybaby adults, for that matter),” he said. “When DSHEA was being negotiated, if somebody had said, ‘Hey guys, what do you think about this?’—everybody would have blown a gasket.”
So, what happens now? Mr. Israelsen believes Obecalp will become the poster child of how screwy the dietary supplement industry can become. “And yet this has nothing to do with supplements or DSHEA,” he said. “But that’s who is going to get blamed.”
Obecalp comes in Cherry chewable tablets and liquid form, and retails for $5.95 per bottle. The product was officially launched in June.
On Obecalp’s website, Ms. Buettner talks about the reasons for launching the product. “I have a baby girl and two sons. One of them always needs my comfort and knowledge that I will make them feel better,” she said. “This is an example of the placebo effect. I invented Obecalp as the first standardized placebo. Ask your doctor about placebo. Trust his advice.” She goes on to say that while she believes in the miracle of modern medicine, she also believes it should only be dispensed when absolutely necessary.
But if this is a replacement for medicine—used to cure, treat, mitigate or prevent sickness—how can it still be called a dietary supplement? To that end, Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT, added, “The product is labeled as a dietary supplement but contains no dietary ingredients. This is a ‘pharmaceutical grade’ placebo, as opposed to a ‘food grade’ placebo? And this is a regular strength placebo. I can’t wait for the ‘extra strength’ version to be launched.”
Mr. Israelsen went on to point out other inconsistencies about the product. “This is the first standardized pharmaceutical inert placebo. I think we have a record here. This is a quintuple contradiction,” he said. “‘Pharmaceutically inert’ makes no sense. If it has no active ingredients, what are you standardizing against? The only thing missing here is ‘Doctor Recommended.’”
While not explicitly claiming to be a therapeutic agent, the point of a placebo is to treat an ailment, even if by deception. Therefore, this product, according to the bounds of the Dietary Supplement Health & Education Act (DSHEA), cannot be considered a dietary supplement. Mr. Israelsen elaborated on this point. “The whole notion of giving kids pills every time they throw a hissie fit is just all wrong and certainly not how the natural health community would approach a crying baby (or crybaby adults, for that matter),” he said. “When DSHEA was being negotiated, if somebody had said, ‘Hey guys, what do you think about this?’—everybody would have blown a gasket.”
So, what happens now? Mr. Israelsen believes Obecalp will become the poster child of how screwy the dietary supplement industry can become. “And yet this has nothing to do with supplements or DSHEA,” he said. “But that’s who is going to get blamed.”
Obecalp comes in Cherry chewable tablets and liquid form, and retails for $5.95 per bottle. The product was officially launched in June.