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FDA Approves Chromium Health Claim

(15.09.2005)


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.
 
 
 
 Related Studies
 
Reports about the biochemistry of chromium in general
 
 J. B. Vincent, Mechanisms of Chromium Action: Low-Molecular-Weight Chromium-Binding Substance, J. Am. Coll. Nutr., 18/1  1999) 6 - 12. DOI: 10.1080/07315724.1999.10718821
 
 John B. Vincent, The Biochemistry of Chromium, Journal of Nutrition., 130 (2000) 715-718. DOI: 10.1093/jn/130.4.715
 
 Diane M. Stearns, Is chromium a trace essential metal?, BioFactors, 11/3 (2000) 149-162. DOI: 10.1002/biof.5520110301
 
 Dion D.D. Hepburn, John B. Vincent, In Vivo Distribution of Chromium from Chromium Picolinate in Rats and Implications for the Safety of the Dietary Supplement, Chem. Res. Toxicol., 15/2 (2002) 93-100. DOI: 10.1021/tx010091t
 
 D.D.D. Hepburn, J.B. Vincent, Tissue and subcellular distribution of chromium picolinate with time after entering the bloodstream, J. Inorg. Biochem., 94/1 (2003) 86-93. DOI: 10.1016/S0162-0134(02)00623-2
 
 W. T. Cefalu and F. B. Hu, Role of Chromium in Human Health and in Diabetes, Diabetes Care, 27/11 (2004) 2741-2751. DOI:
 
 Y. Sun, J. Ramirez, S.A. Woski, J.B. Vincent, The binding of trivalent chromium to low-molecular-weight chromium-binding substance (LMWCr) and the transfer of chromium from transferrin and chromium picolinate to LMWCr, J. Biol. Inorg. Chem., 5/1 (2000) 129-36. DOI: 10.1007/s007750050016
 
 
Reports about health risks and adverse health effects of chromium(III) picolinate
 
 A.K. Mathur, S.V. Chandra, S.K. Tandon, Comparative toxicity of trivalent and hexavalent chromium to rabbits. II. Morphological changes in some organs, Toxicology, 8/1 (1977) 53-61. DOI: 10.1016/0300-483X(77)90023-3
 
 R.P. Wedeen, L.F. Qian, Chromium-induced kidney disease, Environ Health Perspect., 92 (1991) 71-4. DOI: 10.1289/ehp.92-1519395
 
 D.M. Stearns, J.P. Wise, S.R. Patierno, K.E. Wetterhahn, Chromium(III) picolinate produces chromosome damage in Chinese hamster ovary cells, The FASEB Journal, 9 (1995) 1643-1648. DOI: 10.1096/fasebj.9.15.8529845
 
 Walter G. Wasser, Nathaniel S. Feldman, Vivette D. D'Agati, Chronic Renal Failure after Ingestion of Over-the-Counter Chromium Picolinate, Annals of Internal Med., 126/5 (1997) 410. DOI: 10.7326/0003-4819-126-5-199703010-00019
 
 Mark F. McCarty, Over-the-Counter Chromium and Renal Failure, Annals of Internal Medicine 127/8 (1997) 654-655. DOI: 10.7326/0003-4819-127-8_part_1-199710150-00024
 
 J. Cerulli, D.W. Grabe, I. Gauthier, M. Malone, M.D. McGoldrick, Chromium picolinate toxicity, The Annals of Pharmacotherapy, 32/4 (1998) 428-431. DOI: 10.1345/aph.17327
 
 W.R. Martin, R.E. Fuller, Suspected chromium picolinate-induced rhabdomyolysis, Pharmacotherapy, 18/4  (1998) 860-862.
 
 J.K. Speetjens, R.A. Collins, J.B. Vincent, S.A. Woski, The nutritional supplement chromium(III) tris(picolinate) cleaves DNA, Chem Res Toxicol., 12/6 (1999) 483-487. DOI: 10.1021/tx9900167
 
 
 Kevin R. Manygoats A1, Monica Yazzie A1, Diane M. Stearns, Ultrastructural damage in chromium picolinate-treated cells: a TEM study, J. Biol. Inorg. Chem., 7/7-8 (2002) 791-798. DOI: 10.1007/s00775-002-0357-z
 
 Debasis Bagchi, Sidney J. Stohs, Bernard W. Downs, Manashi Bagchi, Harry G. Preuss, Cytotoxicity and oxidative mechanisms of different forms of chromium, Toxicology, 180/1 (2002) 5-22. DOI: 10.1016/S0300-483X(02)00378-5
 
 D.D.D. Hepburn, J. Xiao, S. Bindom, J. B. Vincent, J. O'Donnell, Bioinorganic Chemistry Special Feature: Nutritional supplement chromium picolinate causes sterility and lethal mutations in Drosophilamelanogaster, PNAS, 100/7  (2003) 3766 - 3771. DOI:
 
 D.D.D. Hepburn, J. Marcel Burney, S.A. Woski, J.B. Vincent, The nutritional supplement chromium picolinate generates oxidative DNA damage and peroxidized lipids in vivo, Polyhedron, 22/3 (2003) 455-463. DOI: 10.1016/S0277-5387(02)01369-4
 
 Paul Whittaker, Richard H.C. San, Jane J. Clarke, Harold E. Seifried, Virginia C. Dunkel, Mutagenicity of chromium picolinate and its components in Salmonella typhimurium and L5178Y mouse lymphoma cells, Food Chem. Toxicol., 43/11   (2005) 1619-1625. DOI: 10.1016/j.fct.2005.05.003
 
 
 
Reports about a lack of beneficial effects of chromium(III) picolinate
 
 S.P. Clancy, P.M. Clarkson, M.E. DeCheke, K. Nosaka, P.S. Freedson, J.J. Cunningham, B. Valentine, Effects of chromium picolinate supplementation on body composition, strength, and urinary chromium loss in football players, Int. J. Sport Nutr., 4/2 (1994) 142-53. DOI: 10.1123/ijsn.4.2.142
 
 
 H.C. Lukaski, W.W. Bolonchuk, W.A. Siders, D.B. Milne, Chromium supplementation and resistance training: effects on body composition, strength, and trace element status of men, American Journal of Clinical Nutrition, 63 (1996) 954-965. DOI: 10.1093/ajcn/63.6.954
 
 Lance S. Walker, Michael G. Bemben, Debra A. Bemben, Allen W. Knehans, Chromium picolinate effects on body composition and muscular performance in wrestlers, Medicine & Science in Sports & Exercise, 30/12 (1998) 1730-1737. DOI: 10.1097/00005768-199812000-00012
 
 P. Amato, A.J. Morales, S.S.C. Yen, Effects of Chromium Picolinate Supplementation on Insulin Sensitivity, Serum Lipids, and Body Composition in Healthy, Nonobese, Older Men and Women, J. Gerontol. A Biol. Sci. Med. Sci., 55/5 (2000) 260M - 263. DOI: 10.1093/gerona/55.5.M260
 
 Joanne M. Livolski, Gene M. Adams, Patricia L. Laguna, The Effect of Chromium Picolinate on Muscular Strength and Body Composition in Women Athletes, The Journal of Strength and Conditioning Research, 15/2 (2001) 161–166. PMID: 11710399
 
 M. D Althuis, N. E Jordan, E. A Ludington, J. T Wittes, Glucose and insulin responses to dietary chromium supplements: a meta-analysis, Am. J. Clinical Nutrition, July 1, 2002; 76(1): 148 - 155. DOI: 10.1093/ajcn/76.1.148
 
 J.B. Vincent, The Potential Value and Toxicity of Chromium Picolinate as a Nutritional Supplement, Weight Loss Agent and Muscle Development Agent, Sports Medicine, 33/3 (2003) 213-230. DOI: 10.2165/00007256-200333030-00004
 
 M.H. Pittler, C. Stevinson, E. Ernst, Chromium picolinate for reducing body weight: Meta-analysis of randomized trials, International Journal of Obesity, 27/4 (2003) 522-529. DOI: 10.1038/sj.ijo.0802262
 
 Max H. Pittler, Edzard Ernst, Dietary supplements for body-weight reduction: a systematic review, Am. J. Clin. Nutrition, 79/4 (2004) 529-536. DOI: 10.1093/ajcn/79.4.529
 
 J. E. Gunton, N. W. Cheung, R. Hitchman, G. Hams, C. Sullivan, K. Foster-Powell, and A. McElduff, Chromium Supplementation Does Not Improve Glucose Tolerance, Insulin Sensitivity, or Lipid Profile: A Randomized, Placebo-Controlled, Double-Blind Trial of Supplementation in Subjects With Impaired Glucose Tolerance: Response to Komorowski and Juturu, Diabetes Care, 28/7  (2005) 1842 - 1843. DOI:
 
 James Komorowski, Vijaya Juturu, Chromium Supplementation Does Not Improve Glucose Tolerance, Insulin Sensitivity, or Lipid Profile: A Randomized, Placebo-Controlled, Double-Blind Trial of Supplementation in Subjects With Impaired Glucose Tolerance
Response to Gunton et al
., Diabetes Care, 28 (2005) 1841-1842. DOI:
 
 
 
Reports about beneficial health effects of chromium(III) picolinate for patients having different degree of diabetis
 
 
 Richard A. Anderson, Chromium, Glucose Intolerance and Diabetes, Journal of the American College of Nutrition, Vol. 17/6 (1998) 548-555. DOI: 10.1080/07315724.1998.10718802
 
 
 W.T. Cefalu, A.D. Bell-Farrow, J. Stegner, et al. Effect of chromium picolinate on insulin sensitivity in vivo,  J. Trace Elem. Exp. Med.,  12 (1999) 71–83. DOI: 10.1002/(SICI)1520-670X(1999)12:2<71::AID-JTRA4>3.0.CO;2-8
 
 Nanzheng Cheng, Xixing Zhu, Hongli Shi, Wanling Wu, Jiamin Chi, Jianying Cheng, Richard A. Anderson, Follow-up survey of people in China with type 2 diabetes mellitus consuming supplemental chromium, J. Trace Elem. Exp. Med., 12/2 (1999) 55-60. DOI: 10.1002/(SICI)1520-670X(1999)12:2<55::AID-JTRA2>3.0.CO;2-G
 
 R. A. Anderson, A.-M. Roussel, N. Zouari, S. Mahjoub, J.-M. Matheau, A. Kerkeni, Potential Antioxidant Effects of Zinc and Chromium Supplementation in People with Type 2 Diabetes Mellitus, J. Am. Coll. Nutr., 20/3 (2001) 212 - 218. DOI: 10.1080/07315724.2001.10719034
 
 William T. Cefalu, Zhong Q. Wang, Xian H. Zhang, Linda C. Baldor and James C. Russel, Oral Chromium Picolinate Improves Carbohydrate and Lipid Metabolism and Enhances Skeletal Muscle Glut-4 Translocation in Obese, Hyperinsulinemic (JCR-LA Corpulent) Rats, J. Nutr. 132 (2002) 1107-1114. DOI: 10.1093/jn/132.6.1107
 
 G.J. Ryan, N.S. Wanko, A.R. Redman, C.B. Cook, Chromium as Adjunctive Treatment for Type 2 Diabetes, Ann. Pharmacother., 37/6 (2003) 876 - 885. DOI: 10.1345/aph.1C304
 
 M.F. McCarty, Chromium meta-analysis, Am. J. Clinical Nutrition, 78/1 (2003) 191 - 19. DOI: 10.1093/ajcn/78.1.191
 
 
 
Reports about beneficial effects of chromium(III) picolinate for healthy individuals
 
 G.R. Kaats, K. Blum, D. Pullin, S.C. Keith, R.A. Wood, A randomized, double-masked, placebo-controlled study of the effects of chromium picolinate supplementation on body composition: A replication and extension of a previous study, Curr. Therap. Res., 59/6 (1998) 379-388. DOI: 10.1016/S0011-393X(98)85040-6
 
 
 E. Guallar, F. J. Jimenez, P. van 't Veer, P. Bode, R. A. Riemersma, J. Gomez-Aracena, J. D. Kark, L. Arab, F. J. Kok, J. M. Martin-Moreno, and for the EURAMIC-Heavy Metals and Myocardial Infarc, Low Toenail Chromium Concentration and Increased Risk of Nonfatal Myocardial Infarction, Am. J. Epidemiol., 162/2 (2005) 157-164. DOI: 10.1093/aje/kwi180
 
 
 
Reports about the determination of chromium(III) in food and food supplements
 
 Radmila Milačič, Janez Stupar, Simultaneous Determination of Chromium(III) Complexes and Chromium(VI) by Fast Protein Anion-Exchange Liquid Chromatography - Atomic Absorption Spectrometry, Analyst (London), 119/4 (1994) 627-632. DOI: 10.1039/AN9941900627
 
 Sung-Il Kim, Dong-Jin Woo, Myung-Hee Lee, Gun-Jo Woo, Dae-Kyung Kang, Ki-Won Cha, Determination of Chromium(III) Picolinate Using High Performance Liquid Chromatography-Ultraviolet Spectrophotometry, Bull. Korean Chem. Soc., 24/10 (2003) 1517-1520. DOI: 10.5012/bkcs.2003.24.10.1517
 
 
 


 
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