FDA Extended Compliance Dates for Nutrition Facts Label Final Rules to 2020 and 2021

The U.S. Food and Drug Administration is proposing to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until Jan. 1, 2021.

The FDA is not proposing any other changes to the Nutrition Facts Label and Serving Size final rules.

Written or electronic comments on the extension of the compliance dates are being accepted for 30 days, beginning on October 2, 2017. The FDA is only accepting comments on the extension of the compliance dates and not on the content of the Final Rules published in 2016.

Submit electronic comments to http://www.regulations.gov

The decision was cheered by the industry associations (GMA, Grocery Manufacturer Association), but not so appreciated by consumer’s groups and the CSPI (Center For Science in the Public Interest) which consider the move a danger for public health (added sugars won’t be visible until 2020…) and fear a lack of clarity on the market.

The new Nutrition Facts schemes can be already used on the labels and – in my daily experience – they are requested by many US retailers and importers to foreign clients: therefore, on this last issue, I am totally agree with the CSPI. A co-existence of two different Nutrition Facts schemes on the shelves for 3-4 years cannot help already confused consumers to clear their mind about nutrition information. It is an odd situation also for me that I am used to the convoluted EU legislation making process!

On the other hand, FDA guidance documents on the new labeling schemes will be most welcome in the meantime.

For Additional Information:

QeA to EU Commission – Protecting coeliac consumers and gluten-free logos

Question for written answer
to the Commission
Giovanni La Via (PPE) – 18th February 2016

Subject:  Products containing gluten: protecting coeliac consumers

Coeliac disease is an auto-immune disorder that affects 1% of the European population, in which the immune system can cause malabsorption and increases the risk of nutrient deficiencies, anaemia and osteoporosis, given that the obvious sources of gluten are a commonly-consumed range of food products.

Regulation (EC) No 1169/2011 prescribes a mandatory requirement for the supply of information on all foodstuff labels of substances known to cause allergic reactions and intolerances (including grains containing gluten) every time they are used as ingredients in food. Regulation (EC) No 41/2009 establishes EU harmonised conditions for the voluntary use of ‘gluten-free’ indications, without precluding the risk for people suffering from gluten intolerance.

Does the Commission consider that the only label indication on the presence of gluten, moreover in several foreign languages, may risk consumer confusion?

Does it consider it appropriate to establish harmonised conditions for the mandatory use of ‘gluten-free’ wording or the adoption of a clear and obvious European symbol indicating the absence of gluten?

Answer given by Mr Andriukaitis on behalf of the Commission – 6th April 2016

Regulation (EC) No 41/2009(1) lays down harmonised conditions that food business operators must respect to be able to use the ‘gluten-free’ and ‘very low gluten’ statements in the EU. Such harmonisation ensures the free movement of different foods appropriate to coeliacs’ needs and guarantees that such statements have the same meaning for all EU consumers.

To require operators to provide such statements on a mandatory basis would not be necessary to ensure consumer protection, given that Regulation (EU) No 1169/2011(2) requires, for all foods, the mandatory provision of information on the presence of substances known for their ability to trigger allergic reactions or intolerances (including cereals containing gluten and products thereof) whenever they are used in foods as an ingredient. In order to adequately inform consumers and avoid any confusion, Regulation (EU) No 1169/2011 requires that such information must be provided in a language easily understood by consumers in the Member States where the food is marketed and must be emphasised on food labels through a typeset that clearly distinguishes it from the rest of the list of ingredients.

The use of ‘gluten-free’ logos is not harmonised at EU level. The Commission has no information on the use of such logos at national level or whether their use positively influences consumer behaviour, for example by allowing consumers to identify gluten-free products more easily. For this reason, the Commission does not currently intend to harmonise the use of such logos in the EU.

1) OJ L 16, 21.1.2009, p. 3. Regulation (EC) No 41/2009 will be replaced on 20.7.2016 by Regulation (EU) No 828/2014 (OJ L 228, 31.7.2014, p. 5).
(2) OJ L 304, 22.11.2011, p. 18.

(Source: European Parliament)