Kim Egan, Partner, DLA Piper LLP

I don’t know how I missed this gem but on March 24, 2011, FDA sent a Warning Letter to Jonathan’s Sprouts, Inc., informing the company that it was (among other things) marketing its organic mung bean, alfalfa, and broccoli sprouts as drugs. FDA said it has not approved sprouts as drugs and therefore, the mung bean, alfalfa, clover, and broccoli sprouts are “unapproved new drugs” subject to enforcement action by the agency.

This seems silly at first and reminds us of FDA going after General Mills for unapproved drugs claims on Cheerios. And as a humagetarian myself (will eat meat if produced humanely), I would have expected FDA to go after something other than organic bean sprouts. Like genetically-modified baby sea turtles.

But FDA’s job is to make sure that anything marketed as a drug, including organic bean sprouts, is supported by data demonstrating the safety and efficacy so that FDA can be sure that the benefits of consuming the sprouts (for example) exceed the risks. This also seems silly at first and must just be a technicality so surely Jonathan’s Sprouts can pony up the info and all will be well.

A closer look shows trouble ahead.

Let’s start with mung beans. Mung beans are used to make cellophane noodles and various kinds of jellies and in Hong Kong, a mung-bean flavored ice cream. Jonathan’s Sprouts said that “Mung Bean Sprouts [Have Been] Identified as Potent Anti-tumor Agent” because they contain phytochemicals. FDA knows phytochemicals. Hippocrates extracted a phytochemical, salicin, from willow bark and thus discovered aspirin (salicylic acid). Taxol is an FDA-approved cancer therapy and contains a phytochemical from the Pacific yew tree. FDA knows phytochemicals and all it is willing to concede about phytochemicals in food is about tomatoes, to wit: “Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer.” Mung beans aren’t tomatoes.

Next up are alfalfa sprouts. The most revolting thing I learned about alfalfa preparing this post is that it is a “galactalogue,” which is a substance that induces lactation. The second most revolting thing I learned is that galactalogues not only induce lactation but also attracts insects. Just what a lactating mammal wants. The third most revolting thing I learned is that I have been consuming galactalogues with abandon for some time now. They are found in asparagus.

This company avoided galactalogues and said instead that alfalfa sprouts are “High in [a] Cholesterol Lowering Agent,” namely, saponins. The Internet says (so it must be true) that saponins have antimicrobial and antifungal properties, along with anti-inflammatory and immune-stimulating properties (sounds good!). The problem is they might also be toxic. But Jonathan’s Sprouts also relied on canavines as well as saponins to support its health claims for alfalfa: “Studies on canavanine . . . in alfalfa, have demonstrated benefit for pancreatic, colon and leukemia cancers.” I couldn’t find very much understandable information about cavanine except this rather alarming statement from a New Zealand website: “Any animal that ingests canavanine makes incorrect proteins that malfunction as enzymes. The damage is non-specific and widespread, affecting RNA and DNA metabolism, as well as a key enzyme for destroying alcohol. Because it messes up so many aspects of metabolism, canavanine is a highly toxic chemical to animals. Pigs refuse to eat feed containing too much canavanine . . . [H]umans are not immune to canavanine [and] we don’t seem to taste it.“. If not even a pig will eat it, FDA might have a point.

Next are phytoestrogens which Jonathan’s Sprouts said “prevent . . . osteoporosis,” reduce the risk of breast cancer, control fibrocystic breast tumors and may also have cardiovascular benefits and benefits for diabetics. Phytoestrogens are just want you think they are — female sex hormones. We call them “dietary estrogens” because they come from plants instead of ovaries. That may be the fourth most revolting thing I learned preparing this blog. Regardless, the history of pharmaceutical-grade estrogens has been tumultuous and millions of dollars worth of litigation has ensued and in any event, FDA has not approved a health claim for food that says that estrogens prevent breast cancer or osteoporosis (or anything else).

Finally, broccoli. Jonathan’s Sprouts said there is “strong evidence that just two or three tablespoons of broccoli sprouts a day can help prevent cancer, gastric cancer, and other diseases.” This may be true, and indeed, the Wikipedia entry for broccoli extols its anti-cancer properties. But that same site also bears a big notice saying that as of April 2011, “The neutrality of this article is disputed.” In any event, the most FDA will allow anyone to say about broccoli is that “Broccoli is high in vitamin A and C, and it is a good source of dietary fiber.”

We knew that already.

Kim Egan is Partner in the firm DLA Piper LLP