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SAFEGUARDS | Food NO. 178/16

On September 27, 2016 the US Food and Drug Administration (US FDA) issued guidance for labeling using the claim “healthy”. It also requested information from the industry about changing the regulatory definition in regard to this claim. These changes are happening because of the new nutrition facts panel requirements and to be consistent with the US FDA 2016-2025 Foods and Veterinary Medicine Program’s Strategic plan. [1]

What Information Does This Guidance Contain? [2]

The US FDA has notified the industry that it will take no action at this time if claims of “healthy” are made for products that meet the following conditions: items that are not low in total fat, but have a fat profile that is predominantly mono and polyunsaturated, or a product that contains at least ten percent of the Daily value (DV) per reference amount customarily consumed of potassium or Vitamin D.

The current healthy standards, per 21 Code of Federal Regulations (CFR) 101.65 for products to be low in saturated fat (21 CFR 101.62 (c) and equal to the disclosure level or less for cholesterol 21 CFR 101.13 (h), will still apply for both product groups and the requirement for low fat as defined by 21 CFR 101.62 (b) will apply to those products with at least 10 percent DV of potassium and Vitamin D. [3]

The current definition of healthy for those items low fat, low in saturated fat, not greater than the cholesterol disclosure level and at least 10% DV of one or more of Vitamin A, Vitamin C, calcium, iron, protein or fiber, will still apply.

US FDA Request For Comments On Healthy Claims

The US FDA is requesting comment on whether the “healthy” claim should be modified to have less or no concern of the level of fat, to revise the claim definition concerning the quality of the dietary fat instead of the amount.   

What changes, if any, need to be made for the clarification that a food is a useful part of a healthy life style, and does this nutrient need to be listed next to the claim? These requests for comments, and others, are being brought about because petitions complain that the current standards limit some foods such as nuts, whole grains, seafood, fruits and vegetables which have components, or a component, that form part of a healthy diet but for which the current regulations mean this information cannot be presented to customers on the label.

What Does This Mean For The Food Industry and Consumers?

The industry will be able to place the claim of “healthy” and similar on more products that aid a consumer in a healthy lifestyle. Consumers will be able to choose from more products listing healthy claims, this provides them with access to a greater range of food products that are beneficial to them. [4]

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information, please visit our website: www.foodsafety.sgs.com.

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager

t: +01 973 461 1493

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