Chromium pic wins FDA diabetes and insulin claims

With the US Food and Drug Administration?s approval in late August, chromium picolinate has garnered the 12th qualified health claim in the United States.

The petition, filed by Nutrition 21, recognises chromium picolinate, a nutritional form of the essential mineral chromium, as a safe nutritional supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes.

The approved claim states:
?One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.?

Gail Montgomery, Nutrition 21 president and CEO said: ?We expect several conclusive peer-reviewed studies to publish in the months ahead that should help build evidence to support additional health claims.?

The study cited by the FDA was conducted by William Cefalu, MD, chief of the division of nutrition and chronic diseases at the Pennington BioMedical Research Center, Louisiana State University System. ?Emerging research suggests that 200-1,000mcg of chromium as chromium picolinate may play an important role in carbohydrate metabolism,? Cefalu said. ?The FDA?s ruling acknowledges the importance of nutrition therapies in the prevention of this lifestyle disease.?

Nutrition 21 waited 511 days for a response to its petition. The company?s experience underscores a growing trend at the agency: long delays. Another 18 petitions are awaiting an FDA ruling, and another company, American Longevity, has also waited more than 500 days for a response to its lycopene/cancer petition.

?We move as quickly as our resources allow us to move,? an FDA spokesman said. ?Sometimes we need more information from the company. Sometimes issues touch many different offices and require more review. Resources dictate how long the review process takes.?

According to FDA guidelines, the agency is supposed to send a final decision to petitioners within 270 days. When asked how much of an increase in manpower or budget the division would need to meet this target deadline, the FDA spokesman said he simply didn?t know. ?When the petition process first began, we only had a handful so we could dedicate a lot of time. Then, a big lump came in and we suddenly had many petitions, some containing multiple claims. Now the rate is slowing down a bit.?

Furthermore, the division is responsible for multiple duties beyond just the review of claims petitions, he said.

?Weak claims? for green tea
In July, the FDA approved two health claims for green tea but they are unlikely to appear on product packaging any time soon.

?We did approve two claims but they were very weak,? an FDA spokesman conceded. ?The language was very weak but that?s because the evidence was very weak. It?s all the more reason to do your research before you submit petitions.?

The two claims state: ?Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer;? and ?One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.?

As part of its process, the agency reviewed 223 published studies, 222 of which were conducted outside the US. It deemed only two of them credible.

The petition was filed by Sin Hang Lee, MD, a pathologist and president of Connecticut tea company Fleminger Inc. Upon news of the negative-sounding claims, Lee filed a request that the FDA reconsider its rulings, but does not plan to repetition.

?I don?t know why the FDA threw out almost all of the studies,? he said. ?Two of the studies were major well-respected studies done in Japan that showed green tea blocks the recurrence of breast cancer in stage 1 and stage 2 patients. They rejected those because they said they only will consider studies that look at ?normal? healthy people.?

Lee says he believes the fact he is just a single doctor, without the power and financial resources of a major corporation, hindered his petitions. ?The other petitions — they are usually by big companies with lawyers and lobbyists. I don?t think they took it as seriously as they do other submissions.?

Lee?s petitions took 512 days to be reviewed and were formally delayed six times.

—Joysa Winter

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