Draft guidance released December 4, 2009 by the Center for Food Safety and Applied Nutrition (CFSAN) addressed several issues, but one issue in particular, the banning of supplement containing beverages, could have safety consequences for consumers as the result of the loss of supplement portion control provided by the large volume (as explained below).
Still, the draft guideline is noble in its attempt to follow the law as written. As described in the Federal Food Drug and Cosmetic act §201(ff) “The term ‘dietary supplement’— (2) means a product that—(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or (ii) complies with section 411(c)(1)(B)(ii); (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement… The references to §411(c)(1)(B)(i) and (ii) incorporate language originally used to describe foods for special dietary use, but are applicable to supplements as well and, are as follows: “(c)(1) (B) which—(i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or (ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.”
Clearly, there is no disputing the intent of the law was to avoid the concept of “meal in a pill” and to reinforce the concept with the consumer that “supplements are not foods” by the use of these delivery systems which would eliminate any gustatory hedonics or pleasurable organoleptic sensation. However, despite the good intentions, soon after the passage of the Dietary Supplement Health and Education Act (DSHEA) it became obvious that these coarse delivery systems were simply that – and prevented consumption by those with difficulty swallowing pills (especially large ones) or those who felt that consumption of materials in a drug-like format was psychologically unacceptable and/or set a poor example for observant children. Recognizing the problem, the Food and Drug Administration (FDA) allowed the addition of supplements to snack bars (re-named energy bars) and to beverages, but with the condition the products were clearly labeled as supplements. To its credit, FDA was careful to prevent abuse of this flexibility by preventing clearly conventional foods (e.g., soups, juices and cereals) from containing added herbs or other products that were clearly supplements in a meal vehicle.
The issue of banning supplements administered in liquids (flavored waters or drinks) is problematic because it relies too much on the assumption that consumers will always act in a reasonable manner. The addition of supplements to a standard serving size liquid (8 to 12 ounces) is an effective method for portion control. If the use of supplements in beverages is banned, consumers will likely purchase the supplements as powders or small volume liquids and add them to a bottle of water. Further, because many consumers consider that “if one serving is good, then more is even better,” it is quite probable that multiple daily servings as powders (or other easily dissolved substances) would be added to the bottle of water, teeing up the consumer for a possible toxic effect. As mentioned in the draft guideline, “average daily drinking fluid intake per person [is] about 1.2 liters.” If supplements are allowed in bottled waters, consumers will fulfill the 1.2 liter intake sooner, while ingesting no more supplement than the suggested serving size; otherwise, multiple daily servings could be added to a single 8–12 ounce bottle of beverage. The very fact that supplements are allowed in standard servings of water or energy bars acts as a very effective means for portion control and prevents the potential overdosing from supplements. The fact that the waters or energy bars are flavored is a product of necessity as many supplements are not palatable. Banning standard-size beverages or bars as supplement vehicles is just not a good idea.