Novel Food Information - Chromax® as a source of trivalent chromium in foods for special dietary use
Health Canada has notified Nutrition 21, Inc., that it has no objection for the use of Chromax® (chromium picolinate) as an alternate source of trivalent chromium in foods for special dietary use as defined in Division 24 of Part B of the Food and Drug Regulations (FDR). Chromax®is intended to be used in meal replacements, nutritional supplements, and foods represented for use in a very low energy diet at the same level of supplementation currently permitted for chromium. The maximum level of chromium supplementation currently permitted for use in meal replacements, nutritional supplements, and foods represented for use in a very low energy diet is 20 µg per serving (corresponding to approximately 160 µg chromium picolinate). A maximum level has not been specified for formulated liquid diets and use is determined based on individual requirements.
The Department has reviewed the information provided by Nutrition 21, Inc., in support of the acceptability and safety of Chromax® and conducted the safety evaluation which included assessment of chemical, microbiological, nutritional and toxicological aspects.
The following provides a summary of the notification from Nutrition 21, Inc., and the evaluation by Health Canada and contains no confidential business information.
“Chromax®” refers to chromium picolinate, a stable complex of trivalent chromium, which is intended as an alternative food ingredient to the currently existing forms of trivalent chromium such as chromium chloride, chromium citrate and chromium nicotinate.
In Canada, chromium picolinate is permitted as a source of chromium in natural health products. It is classified as a mineral under Schedule 1, item 7 of the Natural Health Products Regulations and is listed as an acceptable source of chromium in the Natural Health Products Ingredient Database with an upper limit of 500 µg chromium per day.
Chromax® (chromium picolinate) is considered a novel food source of trivalent chromium. Although other trivalent sources of chromium are permitted for use in food, chromium picolinate does not have a history of safe use as a food in Canada.
2. Description of the Novel Food
Chromium picolinate is intended to be used solely as an alternative to other permitted forms of trivalent chromium which have been on the Canadian market. The amount of chromium (III) absorbed from dietary sources is very low, ranging from 0.5 to 2.0% of intake. The source of chromium (III) affects the absorption and its bioavailability in vivo. As chromium is poorly absorbed from the gastrointestinal tract, complexation is necessary in order to increase absorption. Chromium picolinate, like chromium complexed with citrate or nicotinate, has greater absorptive properties resulting in increased bioavailability compared to chromium itself.
3. Product Development/Formulation
The chromium picolinate is produced by chemical synthesis. All raw materials used to produce the chromium picolinate meet either Food Chemical Codex (FCC) specifications or are food grade. The product specification indicates a range of chromium (III) content of 12.18 to 12.64%.
4. Dietary Exposure
Trivalent chromium is an essential trace mineral present in foods such as fruits, vegetables and grains. Although it is widely distributed throughout the food supply, many foods contribute less than 1 to 2 µg per serving. Chromium content is quite variable among different lots of the same food due in part to levels in the soil in which the crop was grown. Other sources of chromium include processed foods, e.g. acidic fruits and vegetables, processed meat and fish, beer and wine, where it may come from exogenous sources such as stainless steel food processing equipment. The average daily intake of chromium from food in the general Canadian population is estimated to be less than 19 µg per day for young children (5-11 year olds); less than 23 µg per day for teenagers (12-19 years) and less than 21 µg per day for adults (20-70 years).
The current recommendation by the Institute of Medicine (IOM) is for an adequate intake (AI) of 35 µg per day for adult men (14-50 years) and 25 µg per day for adult women (14-50 years). As for other age and gender groups, AI levels for chromium are 0.2 µg/day for infants aged 0-6 mo, 5.5 µg/day for infants aged 7-12 mo, 11 µg/day for toddlers aged 1-3 y, 15 µg/day for children aged 4-8 y, 21 µg/day for girls and 25 µg/day for boys aged 9-13 y, 24 µg/day for girls and 35 µg/day for boys aged 14-18 y. For women 51 y and older the AI drops to from 25 to 20 µg/day and for men 51 y and older it drops from 35 to 30 µg/day. In pregnancy the AI is 29-30 µg/day and during lactation it is 44-45 µg/day. With regard to safety, few serious adverse effects have been associated with excess intake of chromium from food so the IOM was not able to establish a Tolerable Upper Intake Level (UL). The Natural and Non-prescription Health Products Directorate of Health Canada recommends a maximum therapeutic dosage for elemental chromium of 500 µg per day for individuals over the age of 19 years. Chromium can be used in natural health products as a single ingredient or as a component of a multi-vitamin/mineral product.
Picolinic acid is a metabolite of the amino acid tryptophan and occurs naturally in the body. Individuals who do not consume picolinate containing supplements are reported to have exposures of 7 to 8 mg per day from metabolism of tryptophan. In comparison, exposure to picolinic acid from the consumption of chromium picolinate is insignificant since 50 µg of chromium supplementation from chromium picolinate provides 0.365 mg picolinic acid. Using chromium picolinate as a source of trivalent chromium at levels as high as 200 µg provides approximately 1.47 mg of picolinic acid, which falls well below the average estimated in vivo exposure of 7 – 8 mg/day from the metabolism of tryptophan.
Exposure to chromium picolinate was estimated using food intake data from the Saskatchewan (1993-94) and the Quebec (1990) Federal-Provincial Nutrition surveys which identified 3.22% of the Canadian adult population as consumers of the proposed food uses for chromium picolinate. However, since chromium picolinate is proposed for use in foods for special dietary use only as an additional source of chromium, it is very unlikely that the current intake of chromium itself would increase for consumers of these products.
5. Chemical Assessment
Certified analytical results for several non-consecutive batches of chromium picolinate indicated the product is a single entity with a narrow range of trivalent chromium concentration (12.18 to 12.68%) ensuring the final product does not contain significant amounts of hexavalent chromium, excess starting materials or other metal impurities. The chemical specifications for heavy metals (<10 µg/g), lead (<0.05 µg/g), mercury (<0.5 µg/g), arsenic (<0.1 µg/g) and cadmium (<0.25 µg/g) in the final product are reported. Given that chromium picolinate is to be a minor ingredient in the foods, the additional dietary exposure to these heavy metals is not expected to pose an unacceptable health risk.
6. Microbiological Assessment
Microbiological safety data was submitted by Nutrition 21, Inc., to demonstrate the specification for Chromax® complies with the standards of the United States Pharmacopeia and National Formulary (USP-NF) with respect to microbial specifications (total plate counts, yeast and mould levels and total coliforms, E. coli, Salmonella spp., Staphylococcus aureus, Pseudomonas aeruginosa) for four non-consecutive batches of the product.
Based on the information provided, there are no microbiological concerns regarding the food use of Chromax® as a source of chromium in foods for special dietary use.
7. Nutritional Assessment
The human body mainly utilizes chromium (III) for the maintenance of carbohydrate and lipid metabolism. Chromium alone has limited bioavailability and is often administered in the form of a complex such as chromium picolinate, nicotinate, or citrate. These complexes have greater absorptive properties resulting in increased chromium bioavailability. The mechanism by which chromium is absorbed in the gastrointestinal (GI) tract is unclear. However, once absorbed, it does not enter the blood cells but competes for binding sites on the iron-transport protein transferrin and forms complexes with other compounds such as nicotinic acid. The primary routes of excretion are the feces and urine with small amounts lost in perspiration and bile.
The comparative absorption of several chromium complexes indicated that chromium picolinate was well absorbed. A 14-day study assessing in vivo distribution and excretion found that the chromium picolinate complex dissociated within 24 hours with the highest concentration found in the liver and small amounts present in the kidney, blood, fat, spleen, testes, heart, pancreas and muscle.
Chromium picolinate is proposed for use as a food ingredient in foods for special dietary use. No information was provided on the use in vulnerable populations including children, lactating women and pregnant women. The use of chromium picolinate in foods for special dietary use will be limited to the maximum levels currently permitted in the FDR (20 µg per serving) for use in meal replacements, nutritional supplements and foods represented for use in a very low energy diet. This corresponds to 160 µg chromium picolinate per serving. In the case of formulated liquid diets, a maximum level is not specified. As an additional source of chromium, the use of chromium picolinate is not expected to increase consumer chromium intake. The nutritional assessment concluded that the use of Chromax® as a food ingredient in foods for special dietary use is safe from a nutritional standpoint.
8. Toxicological Assessment
The toxicological assessment considered more than 35 pre-clinical and clinical studies with the majority of them assessing the impact of chromium picolinate as a dietary supplement on parameters related to body weight, blood glucose and insulin levels. The critical studies included pharmacokinetic (absorption, distribution, metabolism and excretion) studies, short-and long-term oral toxicity studies, a reproductive toxicity study, bacterial mutation studies and mammalian chromosomal aberration studies (in vitro and in vivo). The clinical studies tested chromium picolinate at doses as high as 8045 µg/person/day (equal to 1000 µg elemental chromium/person/day) for as long as 6 months with no adverse effects and no overt toxicity observed.
There are reports that hexavalent chromium industrial exposure can exacerbate chromium dermatitis in chromium-sensitive individuals, but a similar effect has not been reported for trivalent chromium. Hence, there is no evidence to suggest that oral intakes of chromium picolinate would initiate an allergic reaction.
Health Canada does not object to the use of Chromax® (chromium picolinate) as an additional source of trivalent chromium in foods for special dietary use in accordance with the levels of chromium supplementation currently permitted under Division 24 of Part B of the Food and Drug Regulations.
This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.
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For further information, please contact:
Novel Foods Section
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
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