Food and Drug Law

That might sound like a stupid question. I mean, there’s a package right there in the refrigerator that says “hummus” on it. That guy from Arrested Development tells me it’s real hummus. If this country can allow defamation suits over suggesting that “pink slime” is not “ground beef,” why would anyone think to look further than face value on a foodstuff’s name?

But when it comes to hummus — a product that’s spurred legal battles before — the FDA is being dragged into the debate over what it really means to be a vegan’s replacement for protein delightful Mediterranean dip….

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Despite the ever-growing ways that the U.S. Food and Drug Administration regulates what Americans can consume, FDA does not currently regulate genetically modified food. The State of Vermont wants to step in.

This week, Vermont will become the first state to mandate labeling of food products containing ingredients from genetically modified organisms (GMOs). It would require retailers of raw agricultural commodities to clearly and conspicuously label GMO-sourced food with the words “produced with genetic engineering.” (Think ears of corn in your supermarket’s produce section.) Producers of packaged food products must label their products with similar language if any ingredient contained in the product comes from a genetically modified source. (Think of that 56-ingredient protein bar sitting on your desk.)

The bill passed the Vermont House and Senate, and Governor Peter Shumlin just signed it into law yesterday. The law is scheduled to take effect in July 2016.

Why are some people so lathered up about eating ingredients that come from genetically modified crops? “Monsanto” has become a dirty word, with nouveau-hippie parents washing out their kids’ mouths with biodegradable, SLS-free soap when they hear them say it. Unfortunately, much public debate conflates genetic modification, exposure to pesticides, and all sorts of other “unnatural” stuff related to food.

Ironically, genetic modification of seeds aims to make crops more resistant to pests, disease, and drought, thus reducing the need for conventional chemical pesticides and increasing crop yields. A growing world population demands innovation to produce more crops with fewer resources. Billions of people need to eat. Too many GMO opponents seem to picture Dr. Frankenstein when they should be picturing Gregor Mendel or Mother Teresa. (Or, to be fair, Walter De Jong.)

That, however, is only the beginning of what’s foolish about Vermont’s new law . . . .

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The U.S. Food and Drug Administration recently proposed
new rules targeting electronic cigarettes. By its authority under the Food, Drug, and Cosmetic Act and the Family Smoking Prevention and Tobacco Control Act, FDA now regulates “tobacco products” — cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The proposed regulation would “deem” additional products within the scope of the statutory definition of “tobacco product.” FDA would deem electronic cigarettes to be tobacco products, even though e-cigs don’t contain tobacco leaves. The deeming regulation would give FDA the power to govern e-cigs’ manufacture, sale, and use, implementing age restrictions, mandating additional scientific review of products, and scrutinizing claims made by the makers of e-cigs.

The new regulations would prevent e-cigarette manufacturers from telling consumers that their products are a safer alternative than tobacco cigarettes. The deeming regulations would prohibit claiming that vaporized nicotine “presents a lower risk of tobacco-related disease or is less harmful than one or more commercially marketed tobacco products.” In fact, the new rules would prevent them from even advertising to the public that their “product or its smoke does not contain or is free of a substance,” even though e-cigs do not produce smoke and do not contain tobacco in any common-sense meaning of the word.

Banning this sort of claims is absurd: e-cigs lack the more than 4,000 chemicals, many of them carcinogenic, of combustible tobacco cigarettes. Electronic nicotine vaporizers need not be particularly healthy in order to be less unhealthy than traditional cigarettes.

This regulatory push is poisoned by a bevy of bad arguments. Most of the rhetoric consists of pure emotion on the part of anti-tobacco activists. Certain anti-tobacco and anti-smoking factions grow hysterical at the mere specter of smoking. Unfortunately, a more powerful lobby is also trying to squelch e-cigs . . . .

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Does anybody really think Red Bull is good for you? For a moment, I’m not talking about legal standards or product safety or efficacious warning labels. I’m asking, just between us, don’t we all know that ingesting caffeine and sugar bombs is not a healthy thing? People aren’t supposed to have wings. We are terrestrial beings. I’d guess that every ingested substance that has ever made humans feel like they’ve slipped the bonds of gravity is bad for you.

A Brooklyn man downed a Red Bull, played some basketball, had a heart attack, and died. Does it really surprise anybody that this happens every now and again?

Okay, now put your “law talking” hats back on. Is it a wrongful death when somebody drinks something, dies, and everybody besides the manufacturer kind of shrugs and thinks, “Yeah, that’ll dog you”? This lawsuit alleging fraud, failure to warn, and breach of warranty by Red Bull manufacturers is surprising only insofar as it hasn’t been brought a hundred times already…

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Here are three true statements:

(1) Monopolies are generally illegal.
(2) Like baseball, patents make monopoly laws get a little funky.
(3) Courts really really really like to encourage settlements.

So, when two companies get together, and work out a settlement that makes a whole patent infringement lawsuit go away, and the only objection is that pesky Federal Trade Commission complaining that the settlement is anticompetitive, you can understand why a federal court could meditate on points (2) and (3) and dismiss that FTC complaint.

Yet, in FTC v. Actavis, the Supreme Court yesterday made it harder to settle some patent infringement suits, saying that sometimes a settlement of a lawsuit can be an antitrust problem.

How?

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I guess soda pushers will have to go back to slinging rocks.

In case you haven’t been following along with developments inside Mike Bloomberg’s militarized nanny state, last year our elected tyrant outlawed the sale of soda in sizes over 16 ounces at movie theaters and other public places. The mayor felt that nobody needed more than 16 ounces of soda in one sitting, notwithstanding the fact that nobody asked him what my mother thinks.

The law sparked a lawsuit, and today a judge overturned Mayor Bloomberg’s ban.

Bloomberg was not immediately available for comment, most likely because his lawyers were busy drawing up documents to move forward with Bloomberg’s new purchase of the “New York Supreme Court”….

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