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Home ›› About Speciation ›› Speciation News

FDA Approves Chromium Claim

(15.09.2005)

The FDA has issued a favorable response to a qualified health claim petition filed by Nutrition 21 for the nutritional supplement chromium picolinate, though it concluded that any link between chromium picolinate and either insulin resistance or type 2 diabetes remains highly uncertain.

Background:

Chromium(III) is considered an essential trace mineral present in various foods, such as mushrooms, prunes, nuts, whole grain breads, and cereals. A normal American diet contains 50% to 60% of the recommended daily allowance (RDA) of chromium. Since chromium(III) has an extremely low gastrointestinal absorption rate, supplement manufacturers have bound chromium with picolinate (CrPic) to improve the absorption and bioavailability. Chromium deficiency has been observed only in very rare cases of artificial nutrition. Anyhow, chromium supplementation became popular after it was found that exercise increases chromium loss, raising the concern that chromium deficiency may be common among athletes. Chromium seems to function as a co-factor that enhances the action of insulin, especially in carbohydrate, fat, and protein metabolism. Promoters of CrPic claim it increases glycogen synthesis, improves glucose tolerance and lipid profiles, and increases amino acid incorporation in muscle. However, there are also several reports that it can have adverse effects. Most studies of CrPic supplementation reveal no side effects except gastrointestinal intolerance with dosages of 50 to 200 µg/day for less than 1 month. However, anecdotal reports of serious adverse effects, including anemia, cognitive impairment, chromosome damage, and interstitial nephritis have been reported with CrPic ingestion in increased dosages and/or durations.

FDA Approval:

The FDA-approved qualified health claim recognizes chromium picolinate as a safe nutritional supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes.
In a letter to the company, the FDA's Center for Food Safety and Applied Nutrition concluded that there is credible evidence to support the following qualified health claim that “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”.

But the FDA added that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain. The FDA also declined to permit other qualified health claims that were proposed by the company.

Nonethless, Nutrition 21 see the ruling as an important breakthrough.

““The FDA's initial response, while a starting point, is an important milestone in our company's effort to communicate the health benefits of our products,” said Gail Montgomery, president and CEO of Nutrition 21.

“We expect several conclusive peer-reviewed studies to publish in the months ahead that should help build evidence to support additional health claims for chromium picolinate as the first recognized supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes.”

Nutrition 21 holds the patent rights for those applications.

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 200-1,000 µg of chromium as chromium picolinate may play an important role in carbohydrate metabolism,” said Cefalu.

“FDA's ruling acknowledges the importance of preventative nutrition therapies in the prevention of this lifestyle disease.”

The FDA also concluded that chromium picolinate is safe, stating that “the use of chromium picolinate in dietary supplements as described in the [approved] qualified health claims discussed in section IV is safe and lawful under the applicable provisions Act.”

Insulin resistance is an epidemic condition that dramatically increases risk for type 2 diabetes, coronary heart disease and stroke, estimated to affect one in three Americans, according to The American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE).

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims.