Upper limits of sorbitol

CRN Member query:

“Is it acceptable to utilize the upper limit for the ingredient sorbitol permitted for the ‘hard candy and cough drops’ category of food when using sorbitol in chewable tablet dietary supplements, since, in regard to safety considerations, the daily intake of this dietary supplement likely to be less than that of hard candy?”

CRN responds:

Sorbitol is indeed GRAS—“generally recognized as safe”—and as dietary supplements are a category of food in the US, the use of sorbitol as a dietary ingredient is permissible. Regarding the upper limit of sorbitol in various foods, FDA regulation [21 CFR 184.1835(d)] reads as follows:

The ingredient [sorbitol] is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice in the use of sorbitol results in a maximum level of 99 percent in hard candy and cough drops as defined in §170.3(n)(25) of this chapter, 75 percent in chewing gum as defined in §170.3(n)(6) of this chapter, 98 percent in soft candy as defined in §170.3(n)(38) of this chapter, 30 percent in nonstandardized jams and jellies, commercial, as defined in §170.3(n)(28) of this chapter, 30 percent in baked goods and baking mixes as defined in §170.3(n)(1) of this chapter, 17 percent in frozen dairy desserts and mixes as defined in §170.3(n)(20) of this chapter, and 12 percent in all other foods.

As dietary supplements (including applications like chews) are not expressly recognized in this regulation, a strict reading of the regulation indicates that the limit should be 12 percent, as supplements would fall under the classification of “all other foods.” However, from a general risk perspective, the 99 percent limit is conceivably reasonable, as the exposure to sorbitol from the intended use of a supplement chew (used 1-2x daily) is likely to be less than that from the intended use of a candy (used multiple times daily).

The same regulation indicates that exceeding 50 grams/day of sorbitol based on the intended use requires a warning statement about a laxative effect. This level could be used as a limit to manage the regulatory risk when using sorbitol in dietary supplement applications