Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Etienne Nichols
What’s the difference?
Liza Dzhezhora
How to ensure the integration of IoMT devices in your practice
Del Williams
Options to address the risk of combustible dust explosions for NFPA 61 compliance
Doug Folsom
Unpatched vulnerabilities will become increasingly susceptible to cyberattacks
Del Williams
Mitigate risk, prevent safety issues by utilizing closed conveyor systems designed with sanitation in mind

More Features

FDA Compliance News
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community

More News

Kimberly Egan

FDA Compliance

Much Ado About Bean Sprouts

FDA slams producer for touting sprouts’ miracle medical benefits

Published: Thursday, June 2, 2011 - 06:00

I don’t know how I missed this gem, but on March 24, 2011, the Food and Drug Administration (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. The 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 me of the 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 the FDA to go after something other than organic bean sprouts. Like genetically modified baby sea turtles, for instance.

But the 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 the 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; 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. These are used to make cellophane noodles various kinds of jellies. and in Hong Kong, a mung bean-flavored ice cream. Jonathan’s Sprouts says that “mung bean sprouts [have been] identified as a potent anti-tumor agent” because they contain phytochemicals. The FDA knows phytochemicals. Hippocrates extracted a phytochemical, called 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. The only thing the FDA is willing to concede about phytochemicals in food concerns 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 story 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 the term “galactalogues,” an agent that induces milk secretion, 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 antiinflammatory and immune-stimulating properties. Sounds good. The problem is saponins 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 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 nonspecific 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, the FDA might have a point.

Next are phytoestrogens, which Jonathan’s Sprouts says “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 what 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 while researching this article. Regardless, the history of pharmaceutical-grade estrogens has been tumultuous, costing millions of dollars worth of litigation. In any event, the FDA has not approved a health claim for food claiming that estrogens prevent breast cancer or osteoporosis (or anything else).

Finally, broccoli. Jonathan’s Sprouts says 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 it “is high in vitamin A and C, and it is a good source of dietary fiber.”

We knew that already.


About The Author

Kimberly Egan’s picture

Kimberly Egan

Kimberly Egan is a litigation and regulatory lawyer with a background in pharmaceutical and medical device litigation and advice, Consumer Product Safety Commission work, food safety counseling and litigation, and commercial and mass tort litigation. Her food work has included risk-management planning and strategic assessments related to obesity claims, litigation analyses in connection with an acquisition of a company manufacturing dietary supplements, advice on FDA’s food additive and food contact regulations, advice on FDA’s Generally Regarded as Safe (GRAS) regulations, and general advice on food safety issues, product recalls, and supply-chain rationalization. She is a regular contributor to the AssurX blog.


And more ado

Apparently German authorities believe the E-Coli outbreak in Europe may be down to bean sprouts grown there. Definitely not a health Benefit!