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FDA invokes “jelly bean rule” against confectionery calcium claim

By Shane Starling , 16-Mar-2011
Last updated on 21-Mar-2011 at 18:33 GMT

“This should mainly serve as a reminder of FDA's so-called ‘Jelly Bean Rule’.”
“This should mainly serve as a reminder of FDA's so-called ‘Jelly Bean Rule’.”

The maker of a caramel snack making ‘calcium inside’-type claims has been given 15 days to amend its labeling by the Food and Drug Administration because of the product’s unsatisfactory overall nutrient profile.

Goetze's Caramel Creams Double Chocolate packaging bore the nutrient claim, “Fortified With Calcium”, something the FDA took umbrage with due to the product’s high-sugar content.

“Because the product is candy, it does not comply with the policy on fortification of foods,” FDA said, citing Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). It was also misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act).

“The policy on fortification in 21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods, such as candy,” FDA wrote in its March 4 letter to Maryland-based Goetze’s Candy Company.

“Therefore, the ‘fortified’ claim on the product label does not meet the requirements of 21 CFR 101.54(e)(1).”

The jelly bean rule

Food attorneys said the action was consistent with the FDA stance on fortifying “junk foods” with healthy ingredients.

“This should mainly serve as a reminder of FDA's so-called ‘Jelly Bean Rule’,” said Washington DC-based labelling attorney, Ivan Wasserman.

“FDA has historically been concerned about adverse health effects of over-fortification of foods, and as one protection against that has prohibited fortification of things like candy and soft drinks.”

Other violations

FDA also pointed out the suggested serving sizes on the product were not in alignment with the Reference Amount Customarily Consumed (RACC) for candies which is 40g. Goetze’s product suggested 34g - the weight of three of its cream candies.

“We calculate that four caramel creams would weigh 45 grams,” FDA said. “The weight of four caramel creams appears to be closer to the 40g RACC than the weight of three caramel creams. As a result, the nutrition information on your package of Goetz's Double Chocolate Caramel Creams should be based on four caramel creams.”

The stated 7.5 servings per container should have been rounded to the nearest whole number, FDA said, because it contained more than five servings.

The fact the product was labelled with “Double Chocolate” and “chocolate” needed to be qualified with “flavored” because cocoa was in fact the sole source of the chocolate flavor in the product.

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