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Food Stuff: Keep it Simple, Senate!

December 1, 2010 By 2 Comments
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

Teddy Roosevelt, my hero, created the modern food safety system, such as it is. Roosevelt read Upton Sinclair’s book about meat-packing conditions and was so revolted that he told the Department of Agriculture to investigate. The Department of Agriculture’s report was also revolting. Roosevelt waved it around in front of Congress and demanded legislation.

But the beef industry had already visited Congress and the Greatest Legislative Body in the World did nothing.

So Roosevelt pulled a Wiki and leaked parts of the revolting report to the public. Outrage ensued. On June 30, 1906, President Teddy Roosevelt signed the Pure Food and Drug Act of 1906 into law, which aimed to prevent “the manufacture, sale, or transportation of…poisonous or deleterious foods.” Food back then included anything “used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound.” By 1938 that definition had shrunk to the now infamous “food and drink and chewing gum.”

The 1906 Act was only a few pages long and easy to understand.

  • You couldn’t sell food made from “a filthy, decomposed, or putrid animal or vegetable substance.”
  • You couldn’t sell food from “a diseased animal.”
  • You couldn’t sell food if you had added a “deleterious ingredient” to it.
  • You couldn’t sell food if you had removed “any valuable constituent” from it.
  • You couldn’t sell food if you had packed it in a way that negatively “affect[ed] its quality or strength.”
  • You couldn’t sell food if you had “colored, powdered, coated, or stained” it to make it look better than it was.
  • You couldn’t sell food that was masquerading as some other food.
  • You couldn’t sell food without telling the consumer how much morphine, opium, cocaine, heroin, chloroform, or cannabis was in it.

TwinkieWe could have a lot of fun with these rules – does a Twinkie pass any of these tests? Is the very concept of food coloring legal? How about fat-free milk? Spam? Why haven’t I seen a “contains morphine” label recently? Etc.

But my real concern is that the 2010 food safety bill (S. 510) that the Senate passed on Tuesday is not, shall we say, as “crisp” as the 1906 Act. On the seemingly simple subject of how to grow fresh fruits and vegetables, for example, the bill says: “Not later than 1 year after the date of enactment…[FDA] shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agriculture commodities for which [FDA] has determined that such standards minimize the risk of serious adverse health consequences or death.”

I think Teddy would have just said the safest way to grow fruits and vegetables is to plant them in nice clean soil, water them, and pick them when they’re ripe.

The Senate bill goes on to say that FDA must consider “growing, harvesting, sorting, packing” storing, soil standards, temperature control, animal encroachment, water issues, “hazards that occur naturally,” hazards that may be “unintentionally introduced,” hazards that may be “intentionally introduced” including terrorism, natural resource conservation, and wildlife conservation, among other things. And the final rules, which we won’t see for another 2 years, must contain procedures “reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables that are raw agricultural commodities…”

It’s all too much. Why can’t we just have one law that says you can’t grow your fresh fruits and vegetables in a cess pool and that you can’t sell food that contains: (i) feces; (ii) bombs; (iii) decomposing animals; (iv) other rotten things; or (v) unhealthy things. And the latter would be determined by doctors, not politicians, bureaucrats, or cattle farmers.

Kim Egan is Partner in the firm DLA Piper LLP

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FDA Moves To Save “Drunk” College Students

November 17, 2010 By 1 Comment
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

Back in the day, when disco was king, people in white lycra speed-skating suits and feather boas could lean back after a hard night of dancing and sip a rum and coke. A vodka and soda pop after a game of tennis? No problem. Irish coffee at the corner pub? Excellent. Not only excellent, Irish coffee was celebrated. And being of Irish extraction myself, I think that is hilarious. Of course the Irish would put alcohol in coffee — we’d put alcohol in a potato if we could figure out how.

That was then and this is now. FDA is expected to rule today — November 17 — that bottled drinks that mix alcohol with caffeine are unsafe. Say it ain’t so, Uncle Sam. For about a year now, FDA has been looking at drinks such as Joose, Four Loko, Sparks, Tilt, which are popular among college students for combining the kick of caffeine with the fog of booze. The “energy drink,” Joose, for example, has more alcohol than a can of beer.

States have been slowly banning these products and, in September 2009, a group of them wrote FDA and said there is “no evidence to support the claim that caffeine is Generally Recognized as Safe (GRAS) for use in alcoholic beverages.” This might seem backwards to you — aren’t we really upset because we think putting alcohol in “energy drinks” is a deceptive trade practice? In real life, yes, but attacking caffeine is the only way FDA, or any part of the federal government for that matter, can dip its toe into so-called alcopops. FDA regulates food, which we have learned in previous posts means “food and drink and chewing gum,” but not booze. States regulate booze. As does the Bureau of Alcohol, Tobacco and Firearms when illegal trafficking is involved. But not FDA.

The letter from the state attorneys general is fascinating. It says that 90 percent of Americans, including children, consume caffeine every day. It says 28 percent of American college students drink caffeinated alcohol, which is pushing up the rate of “weekly drunkenness” as well as the number of times college students “feel drunk.” Makes sense. It says that “feeling wide awake and drunk at the same time” gets college students into trouble more frequently than students who are just plain drunk, or drunk and sleepy. FDA can’t do anything about the fact that your kid might be falling down drunk. That’s totally off limits. But drunk and awake? That’s a federal issue.

I really don’t mean to make light of the serious health and social consequences of drinking. I personally think alcohol is one of the most dangerous consumer products out there, right up there with smoking. I just think there’s something wrong with a system that might end up telling us that in the interests of public health, we can’t add a little caffeine to an otherwise deadly, but legal, product.

And I don’t think this is going to turn out the way the states attorneys’ general want. In fact, I’m positive of that. Just this morning, Four Loko announced it was voluntarily removing the caffeine from it’s “energy drink.” So now its “energy drink” is just plain booze. Bottoms up.

Kim Egan is Partner in the firm DLA Piper LLP

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Food Stuff: Sex & Drugs & Peanut Butter…Just Another Day for FDA

November 4, 2010 By 1 Comment
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

Is this too boring?

Every week FDA publishes an “Enforcement Report.”  It describes what has gone wrong in our nation’s supply of food and dietary supplements of late.  It would be entertaining reading if it weren’t so depressing.

This week’s report tells us that trying to work more fish and vegetables into your diet may be hazardous.  For example, one company recalled 3,000 packages of fish sticks because they “might” contain plastic. How do they know they “might” contain plastic without knowing whether they actually do?   Another company recalled 20,000 packages of frozen peas and mixed vegetables because they do contain glass — they are sure about that one.

peanutsSome peanut butter, which President Obama told us Sasha eats every day for lunch, came off the shelves because 169 cases of it “was contaminated with pieces of a blue nitrile plastic disposable glove.”  FDA doesn’t say whether it was one blue nitrile plastic disposable glove scattered in 169 pieces through the peanut butter, or 169 different blue nitrile plastic disposable gloves.  Other peanut butter came back because the bottles didn’t say that the peanut butter contained peanut oil.  It seems pretty obvious to me that peanut butter contains peanut oil, but FDA is very strict about requiring companies to label potential food allergens.  That’s why so many packages of raw peanuts warn us that they “contain peanuts.”

A fish distributor recalled 25 different kinds of fish, including some of the cold-water ocean ones we have been told to eat because they are full of Omega-3 fatty acids.  These 25 different kinds of fish — herring, whitefish, turbot, sea bass, paddlefish, trout, butterfish, and numerous “smoked” species — are infected with listeria.  How much of it is in commerce?  Unfortunately, no one seems to know.

There are also problems out there for folks who are trying to get healthy by incorporating more “human companionship” into their lifestyles.  I didn’t realize this before but until recently men have been able to buy a dietary supplement that promises “Ridiculous Performance” and another that says something about “Natural Male Explosions.”  FDA has gone after 10,000 bottles of this stuff.  Why?  They aren’t really dietary supplements.  They are drugs.  The ridiculous performance and natural explosions are the result of something almost identical to the active ingredient in Viagra.   FDA requires the real Viagra label to discuss a “sudden decrease or loss of vision” as well as “a sudden, unsafe drop in blood pressure.”  The Ridiculous Performance and Natural Male Explosions labels presumably did not say any of that.

Pulling up the rear are 3,000 packages of chow mein that smell bad.  That seems a little subjective and culturally insensitive to me.  Who’s to say your smelly chow mein isn’t ambrosia to me?

It certainly is fun to read the weekly food enforcement report but what strikes me about it is that we have all this recall activity even though FDA does not have the power to actually force a recall of anything.  The food safety bill that has been waiting in the wings for almost two years could give FDA the power to recall.  Some say it’s sorely needed.  Some say this weekly enforcement report shows that it’s really not.  Perhaps the Tea Party will clear this up, now that it has a lawmaker or two heading to Washington.

Discuss…

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Food Stuff: Congressional Logic Melts Like Butter

October 28, 2010 By 2 Comments
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

In our last post we learned that Congress spent time coming up with a national definition of “butter”. It struck me as odd, to be honest, that Congress would define food generally and butter specifically and leave the rest for FDA to figure out. The food part makes sense but the butter part seemed a little random.

So I investigated further and learned that not only did Congress take the initiative to define butter, it actually prohibited FDA from doing it. The Food Drug & Cosmetic Act says that FDA shall not promulgate any “definition and standard of identity” for butter. Case closed. It also says that FDA shall not promulgate any “definition and standard of identity” for “fresh or dried fruits” or “fresh or dried vegetables.” That makes some sense to me because Mother Nature has so far done a decent job defining fruits and vegetables. It seems reasonable that Congress would want FDA to focus on manufactured foods (except butter), not ones that spring from earth fully formed.

But no. Congress said that FDA did have the power to define “avocados, cantaloupes, citrus fruits, and melons.” FDA can define avocados but not apples. Melons but not mangos. All of the above but not butter. Okay.

But wait, there’s more. As part of its exclusive jurisdiction over the definition of butter, Congress prohibits anyone from “serving colored oleomargarine or colored margarine” in public unless it warns everyone “in such manner as to render it likely to be read and understood by the ordinary individual” (read, dullard). CAUTION – COLORED MARGARINE ON PREMISES.

A notice in the menu counts as long as it is “in type or lettering not smaller than that normally used to designate the serving of other food items.” Not only that, but it is illegal to serve margarine in separate servings unless “each separate serving…is triangular in shape.” CAUTION – TRIANGULAR COLORED MARGARINE ON PREMISES. I checked to make sure this is still good law and it is.

You might be wondering by now what Congress thinks margarine is. Congress thinks margarine is “any substance[], mixture[], and compound[] known as…margarine” (food is food, don’t forget) and any substance “similar to…butter” that contains “edible oils or fats other than milk fat” but only “if made in imitation…of butter.”

There is an element of intent here. To be a margarine manufacturer, you have to be trying to imitate butter. Colored margarine is margarine that contains “more than one and six-tenths degrees of yellow, or of yellow and red collectively, but with an excess of yellow over red, measured in terms of Lovibond tintometer scale or its equivalent.”

Why so much attention to butter? Congress explained in some tax legislation that it “hereby finds and declares that the sale, or the serving in public eating places, of colored oleomargarine or colored margarine without clear identification as such…depresses the market in interstate commerce for butter and for oleomargarine or margarine…” A depressed butter market is un-American. So let’s regulate the bejeezus of out colored margarine.

Three cheers for capitalism!

Kim Egan is Partner in the firm DLA Piper LLP

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Food Stuff: Onion Rings, Monty Python & FDA

October 25, 2010 By 9 Comments
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

Welcome to Food Stuff – an irregular, irreverent, and hopefully humorous look at food policy, food law, food regulation, food safety, food politics, food fun, food farming, food fashion – in short, Food Stuff. Food is the Temperance movement of the 21st Century. In 2001, Eric Schlosser showed us how we had become a Fast Food Nation. In 2006, Michael Pollan explained what corn does to every person and animal in America. In 2008, Upton Sinclair came back to life as Michael Moore – Food Inc. is to 21st century what The Jungle was to the 20th. In 2009, peanuts turned deadly, and First Lady Michelle Obama said she wanted healthy school lunches and healthy school kids. In 2010, people blanched at eating genetically modified fish. Today, half of all Americans are worried they might get sick from eating tainted products. Americans are getting sick of getting sick from their food.

Let’s start with the basics. What is “food?” The Shorter Oxford English Dictionary says “food” is a substance “taken into the body to maintain life and growth, nourishment; provisions, victuals.”

Congress, on the other hand, says food is — “food.” And also drinks and chewing gum. The Food Drug & Cosmetic Act of 1938 defines “food” as food, drink, and chewing gum and the components thereof. There’s a great piece of lawyering behind why Congress added chewing gum to the definition of food, even though it isn’t taken into the body (except by accident) and doesn’t maintain life or growth, but we’ll leave that for another day.

Congress has also defined “butter” for all Americans. You may not be surprised to learn that butter means “the food product usually known as butter.” And according to Congress, the “food product usually known as butter” is pretty freewheeling and can be made from “milk or cream, or both, with or without common salt, and with or without additional coloring matter,” as long as at least 80 percent of it is milk fat.

FDA has since taken Congress’s definitions of food and butter and run with them. Reading FDA’s food regulations is like listening to Monty Python and the Holy Grail. In America, for example, “[t]he serving size for maraschino cherries shall be expressed as 1 cherry with the parenthetical metric measure equal to the average weight of a medium size cherry.” Macaroni are “tube-shaped and more than 0.11 inch but not more than 0.27 inches” wide. Spaghetti are tube-shaped or cord-shaped (never tubular), more than 0.06 inch but not more than 0.11 inch wide. Vermicelli are cord-shaped, never tube-shaped or tubular. FDA does not explain the difference between tube-shaped and tubular.

Orange juice is, to confirm, “the unfermented juice of the mature orange.”

“Peanut spread” is a “spreadable peanut product” that consists of less than 10 percent peanuts. “Sheanut oil is produced from sheanuts derived from the Shea tree.” There is no Hea Tree.

FDA is high on kelp. You can sprinkle dehydrated kelp over your food or drink or chewing gum to your heart’s content as long as you don’t ingest more than 225 micrograms of iodine. This is much like the rule that you should never under any circumstances eat more than 11 pounds of rhubarb leaves in one sitting or else you’ll die
of an overdose of oxalic acid. I’m sure it’s an oversight that the rhubarb rule is not in FDA’s food regulations.

FDA sets detailed standards for, among other things, describing onion rings that are made from diced onions and not actual onion rings. The regulation says:

Sec. 102.39: Onion rings made from diced onion.
(a) The common or usual name of the food product that resembles and is of the same composition as onion rings, except that it is composed of comminuted onions, shall be as follows:

(1) When the product is composed of dehydrated onions, the name shall be “onion rings made from dried diced onions.”
(2) When the product is composed of any form of onion other than dehydrated, the name shall be “onion rings made from diced onions.”

(b) The words “made from dried diced onions” or “made from diced onions” shall immediately follow or appear on a line(s) immediately below the words “onion rings” in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives:

(1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in the words “onion rings.”

FDA goes into this level of detail for only a few other foods: (i) potato chips made from dried potatoes; (ii) fish sticks made from minced fish; (iii) Pacific whiting; (iv) Greenland turbot; (v) fried clams made from minced clams; (vi) nonstandardized breaded composite shrimp units; and (vii) bonito. You can sell dogtooth tuna in America as bonito fish. Fish, by the way, are: “fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.” Mollusks not destined for a Fisherman’s Stew are not mollusks.

There are some things that FDA considers food (or drink or chewing gum) that will surprise you. Ox bile extract for instance. FDA says ox bile extract is perfectly safe and can be used in cheese with abandon but it does not say how. Ox bile extract is, of course, “the purified portion of the bile of an ox” and is “a yellowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste.” No doubt.

Then there’s The Salts of Furcelleran, which sound like an island chain in Middle Earth, “yeast-malt sprout extract,” which could be a series of declarative sentences in Mandarin, “curdlan,” which I guess is milk that is no longer Generally Regarded as Safe, “molecular sieve resins,” (no comment), and that famous, sprightly Opera singer, candida guillieremondii.

Defoaming agents are fine in food as long as you don’t use them in amounts “in excess of that reasonably required to inhibit foaming.” You can use “hydrogenated sperm oil” to “lubricate [your] bakery pans.” Good to know. But be considerate and use only an amount of sperm whale oil “that is reasonably required to accomplish the intended lubricating effect.”

Milk comes from “one or more healthy cows” whereas “milk products” come from “cows, goats, sheep, [or] water buffalo.” The best sentence I have written in my legal career explains why human breast milk is not “food” (or drink or chewing gum). “Human milk does not come from a cow.” And for this I actually get paid.

I could poke fun at the food regulations forever. But there is a serious issue here. Our government can set detailed standards for ox bile extract and bakery pan lubrication and goes to pains to include water buffalo in its definition of milk products, but it cannot pass legislation to keep our food supply safe. We do not know how many chickens have salmonella. We struggle with how meaningfully to label fat. We resist the Institute of Medicine’s effort to lower our salt intake. We put new medicines through multi-million dollar safety testing but we let defoaming agents into children’s food. We have no restrictions whatsoever on the sale of junk food.

Congress created FDA in 1938 because a toxic elixir killed hundreds, including children. Factory inspections and food standards have been part of FDA’s mission ever since. But FDA does not inspect most domestic food establishments and hardly any overseas ones. Some American children eat volumes of non-nutritious foods while others live below the poverty level and suffer chronic hunger. There must be a happy medium – one that balances freedom of enterprise with the public health and agricultural independence with agricultural responsibility.

Let’s explore these issues here with an open and curious mind. All comments, reactions, outrages, corrections, ideas, compliments and recipes welcome.

Kim Egan is Partner in the firm DLA Piper LLP

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