Acrylamide evaluations in EU and USA – FDA Final Guidance on reduction in certain foods

On 4 June 2015, the European Food Safety Authority (EFSA) published its first full risk assessment of acrylamide in food. Experts from EFSA’s Panel on Contaminants in the Food Chain (CONTAM) reconfirmed previous evaluations that acrylamide in food potentially increases the risk of developing cancer for consumers in all age groups.

Evidence from animal studies shows that acrylamide and its metabolite glycidamide are genotoxic and carcinogenic: they damage DNA and cause cancer. Evidence from human studies that dietary exposure to acrylamide causes cancer is currently limited and inconclusive. To know more about the situation in EU click here or download EFSA’s infographic.

Last week the U.S. Food and Drug Administration (FDA) has issued final guidance to the food industry to help growers, manufacturers and food service operators take steps to reduce levels of acrylamide in certain foods.

Acrylamide is a chemical that may form in certain foods during high-temperature cooking, such as frying, roasting and baking. The National Toxicology Program (an interagency program that evaluates possible health risks associated with exposure to certain chemicals) characterizes the substance as “reasonably anticipated to be a human carcinogen.” And efforts to reduce acrylamide levels are already underway in many sectors of the food industry.

To help mitigate potential human health risks, the FDA’s guidance recommends that companies be aware of the levels of acrylamide in the foods they produce and consider adopting approaches, if feasible, that reduce acrylamide in their products. The guidance also offers a range of steps that growers, manufacturers, and food service operators may take to help reduce acrylamide levels.

For instance, for french fries, the recommended maximum cooking temperature for frying is 345-350 ºF/approximately 170-175 ºC (Refs. 30, 43). Providing appropriate cooking instructions on frozen french fry packages may help reduce acrylamide formation safely during final preparation by consumers and food service operators. Examples of such instructions (which may not be applicable to all products) are:

• Cook to a light golden color. Avoid browning fries.

• Avoid overcooking or undercooking.

• Avoid cooking in a toaster oven to prevent overcooking.

• Reduce cooking time when cooking small amounts.

Through this guidance and various research activities, the FDA is helping companies reduce acrylamide and reduce any potential risks to human health. The focus of this non-binding guidance is on raw materials, processing practices, and ingredients pertaining to potato-based foods (such as french fries and potato chips), cereal-based foods (such as cookies, crackers, breakfast cereals and toasted bread), and coffee, all sources of acrylamide exposure.

Because acrylamide is found primarily in potato-based foods, cereal-based foods, and coffee, the FDA’s best advice for consumers to help limit acrylamide intake is to adopt a healthy eating plan, consistent with the Dietary Guidelines for Americans, that:

• Emphasizes fruits, vegetables, whole grains, and fat-free or low-fat milk and milk products;
• Includes lean meats, poultry, fish, beans, eggs, and nuts; and
• Limits saturated fats, trans fats, cholesterol, salt (sodium) and added sugars.

Additional advice to consumers pertaining to acrylamide, including recommended food storage and preparation methods, is available on FDA website.

See also: Acrylamide – Nothing seems to help on focusonfoodsafety.wordpress.com, by Stefan Fabiansson.

FDA Warning Letter – Misbranding – Whole grain benefits and not authorised claims

Here’s the FDA position about not authorised digestive claims in USA:
FDA WARNING LETTER – MAR 10, 2015
The Food and Drug Administration (FDA or we) reviewed the label for your Post Great Grains Digestive Blend (vanilla graham) product in September 2014. Based on our review, we have concluded that your Post Great Grains Digestive Blend (vanilla graham) product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21, United States Code (U.S.C.), sections 301 et seq.] and the applicable regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
Your Post Great Grains Digestive Blend (vanilla graham) product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that the labeling bears health claims that were not authorized by FDA.
Your product label bears claims that characterize the relationship of a nutrient to a disease or health-related condition. Specifically, your product label bears the following claims: “By consuming at least 48 g of whole grains per day you can support healthy digestion and reduce the risk of several chronic diseases like heart disease and diabetes. New Great Grains Digestive Blend cereal has 41 g of whole grain which is more than 85% of the daily recommended amount!”
A health claim expressly or by implication characterizes the relationship between a substance and a disease or health-related condition [21 CFR 101.14(a)(1)]. Substance means a specific food or component of food [21 CFR 101.14(a)(2)]. The whole grains that are a component of your product are substances within the meaning of 21 CFR 101.14(a)(2), and your label characterizes the relationship of these substances to diseases or health-related conditions (i.e., heart disease and diabetes). Because the product label bears health claims that were not authorized by FDA either by regulation [see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]], the product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
FDA has authorized health claims linking the consumption of whole grain foods to reduced risk of heart disease through the notification procedure in section 403(r)(3)(C) of the Act. Of those authorized claims, the ones closest to the claims on your product label are as follows:
  • “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers.”[1]
  • “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.”[2]
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like heart disease…” is not consistent with either of the above-cited claims that are authorized under section 403(r)(3)(C) of the Act. For example, your claim leaves out any reference to other plant foods and to foods low in saturated fat and cholesterol.
In addition, in a September 11, 2013, letter announcing that FDA would consider the exercise of enforcement discretion[3], FDA articulated two claims for which the agency intends to consider the exercise of enforcement discretion, each of which references the “very limited scientific evidence” linking the consumption of whole grains with a reduced risk of type 2 diabetes. Those claims are as follows:
  • “Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.”
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like…diabetes…” is not consistent with either of the above-cited claims for which FDA announced it would consider the exercise of enforcement discretion.   For example, your claim leaves out any reference to the very limited scientific evidence linking the consumption of whole grains with a reduced risk of type 2 diabetes.
For all of the above-noted reasons, your product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
If you are aware of additional evidence that would support a health claim by regulation or a qualified health claim, we encourage you to submit a petition pursuant to section 403(r)(4) of the Act [21 U.S.C. § 343(r)(4)]; see also FDA’s guidance on qualified health claims, which includes the procedures for submitting qualified health claim petitions.
(Source: FDA website)