FDA Issues Final Guidance on Declaration of Added Sugars for Single Ingredient Products and Certain Cranberry Products

As we discussed previously, FDA’s 2016 final regulation updating nutrition labeling requirements included a requirement to declare added sugars.  This requirement created quite a stir among several segments of the industry.  Among others, the honey and maple syrup manufacturers pushed back on the requirement to include, on single-ingredient packages for these products, a statement (in the nutrition facts box), “includes x g sugars;” the inclusion of this statement was expected to confuse consumers into thinking the honey or maple syrup were adulterated by the addition of sugar.

In March 2018, FDA issued a draft guidance allowing a disclaimer explaining the statement.  However, FDA’s proposed solution was not well received by industry.  In June, FDA announced that FDA was working with stakeholders to devise a (more) sensible solution.  Subsequently, on Sept. 6, 2018, then-Commissioner Gottlieb announced that FDA was drafting the “final guidance, which [FDA] anticipate[s] issuing by early next year.”  Then in December 2018, the President signed the Farm Bill including a provision prohibiting FDA from requiring a statement “includes x g sugar” on single ingredient packages or containers of pure honey, maple syrup and other single ingredient sugars and syrups.  Last week, about six months after the Farm Bill was enacted, FDA issued final guidance advising industry what, according to FDA, this means for the nutrition facts box for these products.

Consistent with the Farm Bill, the single-ingredient products are not required to declare the number of grams of added sugars in a serving of the product on the Nutrition Facts box but must still include the percent Daily Value (DV) for added sugars. In other words, FDA believes that it can require declaration of %DV for an undeclared nutrient.  FDA further states that it intends to exercise enforcement discretion for the use of the “†” symbol immediately following the %DV declaration, which leads to a footnote inside the Nutrition Facts label which explains the amount of added sugars that one serving of the product contributes to the diet as well as the contribution of one serving of the product toward the percent DV for added sugars or a similar non-misleading statement.  The inclusion of the footnote is not mandatory.  The guidance as well as a fact sheet include an example.

The honey and maple industries were not the only ones objecting to FDA’s final rule.  The cranberry industry also raised objections .  Cranberry juice naturally contains little sugar but is so tart that making it palatable for the consumer demands the addition of sugar (or another sweetener).  The added sugars must be declared as added sugars.  A juice, such as grape juice, that is naturally sweet, need not be sweetened to be palatable.  As a result, consumers comparing the nutrition information of a cranberry juice and grape juice, may avoid cranberry juice; even though the total sugar content of the two juices is similar, the amount of added sugar in cranberry juice is significantly higher than the amount of added sugar in grape juice (which will be 0 g).

Consistent with the draft guidance, FDA maintains its position that cranberry beverage products and certain dried cranberry products must declare added sugars in grams as well as the %DV for added sugars.  However, FDA will exercise enforcement discretion by allowing the use of a symbol immediately following the %DV for added sugars.  This symbol will link to a statement outside the Nutrition Facts label explaining that sugars are added to improve the palatability of naturally tart cranberries.  FDA provides examples of several possible statements none of which appear to address the total sugar content of the cranberry product vs. the naturally sweeter product.

In the Federal Register notice, FDA notes that it may consider the same type of enforcement discretion discussed with respect to certain cranberry products for other naturally tart fruits for which the amount of total sugars per serving is at a level that does not exceed the amount of total sugars in a comparable product with no added sugars.  Acai berry juice products do not fall in that category.

Overall, FDA is giving manufacturers of single ingredient packages/containers of pure honey, maple syrup, other pure sugars and syrups, and certain cranberry products enforcement discretion until July 1, 2021 to comply with the new nutrition labeling requirements, i.e., approximately two years after publication of the final guidance.  This will give these manufacturers additional time to make label changes consistent with the final regulations, the Farm Bill and FDA’s guidance.