In January of this year, FDA released its Guidance for Industry, Distinguishing Liquid Dietary Supplements from Beverages.[1]Other than stating the obvious (i.e., offering a supplement as a substitute for a food) or a recitation of settled (or undisputed) regulation (as in “settled law”), the Guidance takes a potentially sinister turn, laying out the ground work for imputing intent, when evidence of intent may only be apparent to the agency.
It is unlikely that anyone disputes the meaning or intent of the law in the definition of a dietary supplement (21 USC 321(ff)) in that a dietary supplement “is not represented for use as a conventional food or as a sole item of a meal or the diet.” Nor, as the guidance states, should the product name, marketing practices or representations violate the spirit of the law, by implying the supplement and its delivery system is represented as a conventional food. However, when the agency claims that packaging, recommended conditions of use, serving size or composition, et cetera, may be considered in determining intent to market a violative product, this sows the seeds for arbitrary decision making. That is, the agency is sure to announce that it will take into consideration a constellation of factors to determine if a product is violative, there is nothing in this guidance to prevent taking action on an isolated product attribute.
Examples within the Guidance include language that a product is a conventional food if it bears a statement that the product is intended to “rehydrate”, which everyone can agree this would mean replacement of body water by the food, known as water. However, as noted in the Guidance, the term, “refresh” as a synonym for rehydrate and therefore characteristic of a food application is a “bridge too far.” After all, a cold shower, a walk or a few minutes of meditation can all refresh.
The Guidance also cites packaging and implies that a re-sealable package is indicative of a packaging seeking to emulate food, as if the presence of a screw-top cap has the potential to make any substance within it, a food. And, if presumably, the packaging of a dietary supplement in a single use container (such as a pop-top can), would not make a supplement a beverage, what does that make the 452 billion cans of beverages sold each year?[2] Presumably the intent of a single use container (like Russian vodka bottles of the past), implies that once opened, the entirety of the contents must be consumed. However, the Guidance also gives the example: “For example, packaging a liquid product in a red twelve-ounce pop-top aluminum can bearing a silver stripe with the name ‘cola supplement’ printed in script on the can could be considered an implied representation that the product is a cola-flavored soft drink that is intended to be consumed in a single serving like other canned soft drinks.” The name of “cola supplement” would likely be considered violative if not further qualified, but it would seem that the use of a pop-top can would be compliant as being non-food-like, according to earlier descriptions in the Guidance. Is it really a matter of a constellation of factors determining food status, or can volume be isolated as a determining factor as to whether or not something is a food?
The framers of the bill, which eventually became the Dietary Supplement Health and Education Act, were logical in their thinking that a dietary supplement should “not be represented as conventional food and is not represented for use as a sole item of a meal or of the diet” [if it could not otherwise be marketed] “for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form”. Early on in the process of application of the law, FDA was more flexible allowing supplement bars and drinks as a vehicle for supplements, albeit in a form similar to food. This accommodation by FDA for larger delivery systems was also at a time of concern for the youthful eyes observing parents “popping” pills (use of the pejorative is intended) ― kudos to FDA for its sensitivity to this important issue.
Now, FDA seeks to undo the good it has done and with its seemingly inevitable restriction on the size of delivery systems – barring supplement containers in bottles with caps, presumably resembling food containers (i.e., bottled water) and likely “energy bars” as well. This move to smaller volumes also has implications for the safety of the consumer, something FDA has apparently overlooked in this instance in its crackdown on potential food poseurs. That is, use of a larger volume, within which the supplement is dissolved, is often a safety mechanism to thwart possible overdose. If the supplement is presented as a powder in a capsule or sachet, or even a crushable tablet, there will be the temptation to employ the dictum “if one is good two are better” and lead to the practice of dumping several daily doses into a single serving size bottle of water. It should be obvious that the larger volume product is made safer through the use of dilution! As the Guidance notes, the average fluid intake per person is 1200 ml, and if a bottle the same size as a bottle of water is used, then consumption of a single 500 ml bottle will likely not be followed by another very soon. If the supplement is known to be excreted quickly and a specific blood level is desirable, or if solubility issues prevent achieving a high enough daily dose with one container, use of more than one container with water as the medium is unlikely to result in harm. The Guidance implies that the daily intake of 1200 ml of fluid cannot be from supplements, but even if the daily supplement dose is via a water vehicle, what is the offense, where is the harm? It is unlikely people will feel compelled to drink 1200 ml of fluid in addition to what was delivered through a supplement, as people self-titrate fluid consumption and stop when they are no longer thirsty.
With its liberal use of warning letters to curtail outlier activity in the supplement arena, the Guidance seems superfluous for its stated use. More likely, this Guidance sows the seeds for potential abuse to selectively employ the threat of enforcement in an arbitrary and capricious manner. Especially offensive is the power to impute intent, which goes far beyond the traditional utility of labels on FDA regulated products to designate functionality and potentially subjects industry to regulation by fiat.