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FDA Protects Us From Terror of Unpasteurized Milk

August 8, 2011 By 5 Comments

Patrick Stone, President, TradeStone QA

I don’t know about you, but I sleep easier now knowing that our FDA has declared war on unpasteurized milk in America! It is not enough the US Government is fighting the war on terror (oxymoron) in dozens of countries, the war on drugs, the war on cybercrime, and now the war on unpasteurized milk. Yes, our tax dollars are hard at work, ladies and gentlemen.

For those just joining us, the results so far of these wars is economic collapse. Small business is the only hope for America now otherwise we might as well sign our souls to whomever owns our debt.

I am not sure that unarmed Amish & Quakers or any milk guild selling unpasteurized milk & cheese should be “taken down” with automatic weapons at the ready.  These are Americans trying to make a living.  FDA should educate food producers or show proof positive that adverse events/deaths have occurred from their dairy farm’s product — then go in without the guns blazing. Check the Constitution: innocent until proven guilty still applies.

Raw MilkAs a former inspector, I understand and did my duty when individuals knowingly caused harm or by acute negligence caused harm to another human.  But I feel ashamed to be associated with the FDA with this brand of overkill.

The burden of proof is on the government to show willful harm to the public.  I have not seen the “bodies stacking” up from individuals drinking unpasteurized or blending raw eggs into a protein drink.  An estimated 9 million individuals choose to drink raw milk each year with low ill effect (estimate by CDC, May 2011).

The CDC is a branch of HHS and tied to FDA; why are they on opposite sides of the table on this issue?  This is waste and politics at work with numerous health related issues causing death and disease waiting for FDA’s attention.  What is the real problem (Milk lobby)?

I do not condone “risky” behavior, however this is America and we can choose to live on the edge for freedom of choice.   How about making the consumer sign a waiver noting that they’ve been informed about the possible dangers and let them choose?

The possible dangers associated with consuming milk that is unpasteurized depend on the age of the consumer.  Vulnerable populations are susceptible to bacteria and viruses found in unpasteurized milk.  How do we know these individuals purchasing the “bad milk” are not heating or cooking this milk before consuming it.  The market sells many raw foods meant for cooking and there are many ways to get food regulation compliance.

Work with the market FDA, it’s your duty.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Organic Bean Sprouts Can Kill You

May 4, 2011 By 3 Comments
Kim Egan

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

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Congressional Committee to Reduce Waste Eliminates Self

March 3, 2011 By Leave a Comment
Kim Egan

Kim Egan, Partner, DLA Piper LLP

It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly.  The federal government recently “identified a mother lode of government waste and duplication” and decided that getting rid of it “could potentially save billions of tax dollars annually and help agencies provide more efficient and more effective service.”  This according to Sen. Tom Coburn, R-Okla. and the Government Accountability Office (GAO) in response to the GAO’s first ever audit of federal agency overlap.

One of the biggest culprits is food safety.  There are over 30 food-related laws administered by 15 different federal agencies and still the public lacks confidence in the safety of our food supply.  What to do?

GAO recommends that as “a next step, the Director of the Office of Management and Budget, in consultation with the federal agencies that have food safety responsibilities, should develop a government-wide performance plan for food safety that includes results-oriented goals and performance measures and a discussion of strategies and resources.”  What does that mean?  It sounds an awful lot like the “next-generation-platform-based-information-management-solutions” type stuff we heard about during the tech boom.

GAO insists that “[w]ithout a government-wide performance plan for food safety, decision makers do not have a comprehensive picture of the federal government’s performance on this crosscutting issue.”  In other words, if no-one tells the boss what’s going on, the boss won’t know what’s going on.  Let’s definitely fix that.

GAO also wants Congress to ask the National Academies of Science to ask a blue ribbon panel of experts to come up with some “alternative food safety organizational structures.”  The GAO proposes that Congress ask the NAS to ask the blue ribbon panel to consider the excellent example of Europe.   Somehow I don’t think our Tea Party Congress will cotton to that idea.  Europe has one food safety agency and one, transparent set of food safety rules.  That seems so sensible, no?

The GAO also appears to recommend Food Communism: “a coordination mechanism that provides centralized, executive leadership for the existing organizational structure, led by a central chair who would be appointed by the president and have control over resources.”  The Tea Party won’t like that either.

Because the solution to our food problems is to become more European, we can rest assured that nothing at all will change.  We will stick with our quaintly provincial and silly system of food regulation.  FDA will continue to make sure that shell eggs are properly labeled while the USDA’s Animal and Plant Health Inspection Service will continue to ensure the health of the chicks that hatch from them.  FDA will continue to regulate products made from the shell eggs (that one hopes were properly labeled) while USDA’s Agricultural Marketing Service will continue to grade eggs for beauty and purity.  And it will continue to be the case that nobody at all in the federal government will be making sure that the eggs sold in your local grocery store are free of Salmonella.

The good news is that it’s not just food that gets taken to task in this report.  The GAO says we could probably save some money “defending our northern border” from our staunch Canadian ally as well, ironically, as our efforts to identify government overlap.  No. 14 on GAO’s list of things to de-dupe is “Enterprise Architects,” which it says are “key mechanism for identifying overlap and duplication.”

What a waste.

Kim Egan is Partner in the firm DLA Piper LLP

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Food Stuff: Wilts, Smuts, Blotches and Rots

February 7, 2011 By 1 Comment
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

For reasons I won’t bore you with, I recently typed “Karnal Bunt” into Google followed shortly thereafter by “smut.”  No, not the smut you’re thinking.  “Smut” comes from the German for “dirt” and refers to a collection of revolting plant diseases.

Smuts are fungi.  I know this because my Googling sent me straight from “Karnal Bunt” to “corn smut” to a place where I could build my own “fungi portal.”   There are many kinds of smut, all of which are regulated by the Department of Agriculture.  That is a sentence I never expected to type.  There is the aforementioned “corn smut” and also “sugarcane smut” and the “common smut” and the “loose smut“.  Loose smut kills barley, along with reputations.

Smuts are in the same family as rusts and presumably blights.  A rust is a dark smut.  There is cedar apple rust and white pine blister rust and wheat rust and daylily rust.

Blackleg potato

Blackleg potato rot | Photo by Gary D. Kleinschmidt | UC ANR

Blights are a bummer.  The chestnut blight destroyed one of the stateliest American trees.  And there’s a blight (or smut, I’m not sure) that causes Sudden Oak Death.  Fire blight kills pears.  Water mold caused the famous Irish Potato Blight.  Potatoes also get something called “bacterial wilt” and something else called “soft rot” and something else called “blackleg.” Potatoes can get “ring rot” and “pink eye” and “common scab” and “zebra chip.”  The zebra chip diseases gives potato chips black lines like a zebra.

Many plant diseases sound like they were dreamed up around a peat fire in a thatched hut somewhere on the MacGilliycuddy Reeks or the Heptonstall Slacks.  Plants get blotches, cankers and galls. Apples get fruit blotch and twig canker.  Caneberries get leafy gall.  There’s a disease called the “boysenberry decline.”   There’s something called “black speck”.  Citrus fruits get the “blast” and “damping-off” and the dreaded “sooty blotch.”

Plants also get viruses.  There’s “bud union crease” and “crinkly leaf” and “navel infectious mottling.”  Plants can spread contagious pathogens — the “fatal yellows” or the “rumple of lemon fruit.”  Oranges get sunburn. Lettuce get stunt. Peanuts get scorch.

No problem, you say.  I will just buy my produce at a supermarket to be sure I’m not eating wilts or blotches or rots.

But then you might be eating bug secretions.  This goes for vegetarians or vegans, too.

That’s because grocers can wax their fruit and vegetables with something called “food grade shellac.”  When slathered on candy it’s called “confectioner’s glaze.”  Shellac comes out of the glands of the female lac bug.  You see it most frequently on apples.   Sometimes it contains crushed insects.  It is exactly the same stuff you use to polish a wood floor.

Enjoy.

Kim Egan is Partner in the firm DLA Piper LLP

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Of Fruits and Vegetables, and Everything in Between

January 24, 2011 By 1 Comment
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

It might surprise you to learn that FDA has taken the time to promulgate a regulation that identifies the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. See 21 C.F.R. sec. 101.44. As a result we now know that the 20 most frequently consumed raw fruits are apples, California avocados, bananas, cantaloupes, grapefruits, grapes, honeydew melons, kiwifruits, lemons, limes, nectarines, oranges, peaches, pears, pineapples, plums, strawberries, sweet cherries, tangerines, and watermelons. And the 20 most frequently consumed raw vegetables are asparagus, bell peppers, broccoli, carrots, cauliflower, celery, cucumbers, green snap beans, green cabbage, green onions, iceberg lettuce, leaf lettuce, mushrooms, onions, potatoes, radishes, summer squash, sweet corn, sweet potatoes, and tomatoes.

Do these lists interest you at all? They interest me. What is a “vegetable” anyway? Why is a banana a “fruit” but a squash is deemed a vegetable? Why are tomatoes called vegetables but nectarines are fruit? Why are watermelons fruits but cucumbers vegetables? What would you call a beet and why isn’t it on the list of 20 most frequently consumed vegetables? Do we really eat more kiwis than raspberries or blueberries? Isn’t a mushroom a primeval parasite and not really a plant at all?

Harold McGee, the food scientist and author of On Food and Cooking, is my kind of guy because he’s taken up this subject with gusto. Fruits are, technically speaking, the reproductive organs of plants. Everything on the 20 most frequently consumed raw fruits list has a seed in it somewhere. But then why do we call green beans, eggplants, cucumbers, and corn vegetables when they, anatomically speaking, are fruits? And then there’s the tomato, the most famous vegetable-that-is-really-a-fruit.

McGee wonders if the distinction is that fruits are plants that are sweet and tasty and vegetables are plants that are nutritious and wholesome. “The apple of your eye” and “what a peach” and “life is just a bowl of cherries” are good things. “You’re nuts” or “that’s not worth a hill of beans” are bad things. McGee goes off on a tangent about how the lemon fits into this equation — long story short, it looks like it should be sweet but it isn’t at all. It’s a deception — a lemon.

We in America are fortunate that we can turn to our Supreme Court for an answer. It has been the law of the land in America since 1893 that a tomato (and by extension the cucumber and the green bean) is a vegetable, even though it has seeds like a fruit. The story is that a 19th century food importer wanted to bring a load of tomatoes in from the West Indies tax free, arguing that tomatoes were botanical fruits and thus exempt from the import duty. The Supreme Court, apparently mindful of the benefit unrestrained tomato tax revenue would have on the public coffer, said no, tomatoes are vegetables and thus taxable. The Court held that tomatoes are “usually served at dinner in, with, or after the soup, fish or meat, which constitute the principal part of the repast, and not, like fruits, generally after dessert.” Nix v. Hedden, 149 U.S. 304 (1893).

For you lawyers out there, Nix v. Hedden is still good law. The Second Circuit cited it in 1990 for the proposition that common usage can trump science when it comes to commerce. “In common parlance tomatoes are vegetables, as the Supreme Court observed long ago [in] Nix v. Hedden 149 U.S. 304, 307, 13 S.Ct. 881, 882, 37 L.Ed. 745 (1893), although botanically speaking they are actually a fruit . . . Regardless of classification, people have been enjoying tomatoes for centuries, even Mr. Pickwick, as Dickens relates, ate his chops in ‘tomata’ sauce.” JSG Trading Corp. v. Tray-Wrap, Inc., 917 F.2d 75 (2d Cir. 1990).

I am also told that the New Jersey legislature cited Nix in 2005 when it voted to make the tomato the state vegetable of New Jersey. This apparently alarmed some people because the tomato is not an entirely benign plant. For starters, it’s a member of the nightshade family, along with eggplants, the hallucinogenic jimson weed and, of course, the deadly nightshade. Moreover, only the crazy Italians were brave enough to eat a tomato for the longest time — the English and the French thought it was poisonous because it turns out the tomato plant leaves are, actually, rather deadly. And even though the English called them “love apples,” the Latin name for tomatoes is lycopersicon esculentum. Translation — “edible wolf’s peach.”

I’d love to see a “Candied emulsion of organic edible wolf’s peach” on the menu at, say the Gramercy Tavern or Restaurant Nora.

Kim Egan is Partner in the firm DLA Piper LLP

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New FDA Food Law Light on Funding?

January 11, 2011 By 1 Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The new FDA Food Safety Modernization Act sounds like a huge change for the food industry because it gives new enforcement powers to the agency and may put more burden of proof on food manufacturers.

“The bill will usher in a new era of food-safety regulation, with increased enforcement, stiffer penalties and broader record-keeping requirements for high risk food,” says a new mini-report, PricewaterhouseCoopers.

That said, some nagging questions remain such as to whether there will be enough funding behind this law to give it any enforcement teeth.

“There is some feeling in the food safety industry, that this bill may have difficulty being funded,” Cindy Rice, RS, MSPH, CPFS, Food Safety Specialist told us this week. Rice is President of Eastern Food Safety, a food safety educator and consultant to the foodservice and regulatory industry and also the food safety expert for ECOLAB, an international food safety and sanitation company.

“Though commonly described in terms of the new powers it gives FDA, it’s the new obligations that fall directly on food businesses that will make the biggest difference to most companies,” food industry attorney Eric Greenberg told us.

For food companies, the new requirement for implementing hazard analysis and critical control point programs – to be implemented in 18 months – represents the most complex new obligation, he added. “It will require companies to evaluate their processes, identify hazards, put in place controls against those hazards, and maintain records of their actions, otherwise the food they make will be adulterated and unlawful,” Greenberg says. It’s worth noting that small businesses are exempt from these requirements.

However, while the ink is still drying on the actual law, there’s still time for food companies and other to weigh in and perhaps influence some changes.

Greenberg, notes, “Many of the law’s provisions require FDA to make regulations to implement them, so companies should be alert to the process in coming months, because they will have opportunities to offer their views on proposed regulations and thus shape their final form.”

So, is this a big deal or not? Depends a little on who you ask.

Despite the funding concerns, Rice says the bill remains important for these reasons:

  1. FDA would have the authority to “Recall” a defective, or adulterated product from stores, distributors, supermarkets, etc. Currently, FDA has no power to recall a product, and can only suggest to a manufacturer that their product be recalled from public consumption and distribution. It is up to the manufacturer to “voluntarily” recall a product that has been implicated in an outbreak, or has some harmful risks associated with it.
  2. All manufacturers and processors would be required to undergo regular food safety and sanitation inspections (yearly), and maintain records that show that they are following an effective food safety plan, that minimizes risks at every step of production of that food. This plan would ensure that production procedures are safe in terms of water quality, processing and sanitation, pest control, animal control and contamination, transport, distribution channels. Also manufacturers would be required to keep records of their safe procedures, and can be used for traceback purposes. In short this food safety plan (referred to also as HACCP plan) minimizes the risks to food at every step of production.
  3. Farmers and growers would be required to also follow a written food safety plan for its produce and livestock, and maintain such records, unless the farm has less than $500,000 in sales annually. This plan would ensure that production procedures are safe in terms of water quality, processing and sanitation, pest control, animal control and contamination, transport, distribution channels. In short this food safety plan , which also includes record-keeping and labeling of product in distribution, minimizes the risks to food at every step from farm to table and also helps traceback food to its source in case of an outbreak.

Greenberg points to another potentially important aspect of the new law. “FDA is ordered to prioritize food inspections according to risk, and to increase the rate of inspections.” The agency must study what foods are at high risk of intentional contamination (such as by terrorists) and set rules to protect them. Imported foods are now going to come from suppliers who can verify they are made in compliance with good manufacturing practices, and will set up a system of third-party auditors to check them out.

It all sounds good, but will the funding materialize or will this remain a group of tough words? Watch this space.

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Dreaming of a Vanilla Christmas

December 16, 2010 By 2 Comments
Kimberly Egan

Kim Egan, Partner, DLA Piper LLP

It’s the holiday baking season, which means a lot of vanilla extract is moving through the stream of commerce.  So, just what is vanilla extract, anyway?

Vanilla extract is made from vanilla beans.  Vanilla beans do not grow on a vanilla bush the way cocoa beans grow on a cocoa bush.  Vanilla beans grow on a pretty tropical flowering plant, the flower of which is called…an orchid.  Vanilla beans are orchid seeds.  The vanilla bean orchid plant is native to Mexico and Cortes took it back to Spain with him along with chocolate.  Chocolate and vanilla (and corn and tomatoes) are as American as apple pie.

Before FDA, people made vanilla extract by sticking vanilla beans into the liquid of fermented potatoes, corn, and other things found lying around the Americas.  Liquefied fermenting potatoes, corn, etc., create ethanol, known in Europe as vodka.  Take three vanilla beans and one cup of vodka, stuff it all in a glass jar with a tight lid, shake it around, and wait 2 months.  Voila!  Vanilla extract.  When you start running low, add more vodka.  If you want to sell it for thousands of dollars an ounce, call it “Artisanal Vodka-Infused Mexican Orchid Seed Reduction.”

Other cool things to know about vanilla are that Obelisk’s mother in the Asterix series is named Vanilla and there is a kind of Japanese cartoon pornography called The Vanilla Series.

Now back to FDA.  It says vanilla beans are “the properly cured and dried fruit pods of Vanilla planifolia Andrews and of Vanilla tahitensis Moore.”  FDA says “[v]anilla extract is the solution in aqueous ethyl alcohol of the sapid and odorous principles extractable from vanilla beans.”  Sapid means tasty and odorous means smelly.  At least 35 percent of the liquid must be alcohol.  At least one part per gallon must be vanilla.

Less than 35 percent alcohol and your product is merely “vanilla flavoring.”  More than two parts per gallon of vanilla and your product is “concentrated” vanilla extract.  Then there is “vanilla powder,” ground up vanilla beans to which you are permitted to add sugar, food starch, gum acacia, and corn syrup.  You can even add “anti-caking” ingredients, none of which you would ever eat voluntarily because they are also known as “talcum powder.”

Digging deeper, there are rules about vanilla-vanillin extract, flavoring, and powder, all of which are the same as the above except you can add 1 ounce of “vanillin.”  FDA does not define “vanillin”  but Wikipedia does:  “It is the primary component of the extract of the vanilla bean. It is also found in roasted coffee and the Chinese red pine.”  The last bit is a little jarring.Vanilla Bean

All of this assumes that you know how to weigh your vanilla beans, which is more complicated than you might think.  FDA consulted both the National Archives and the Association of Official Analytical Chemists (AOAC) and shares that a “unit weight of vanilla beans means, in the case of vanilla beans containing not more than 25 percent moisture, 13.35 ounces of such beans; and, in the case of vanilla beans containing more than 25 percent moisture, it means the weight of such beans equivalent in content of moisture-free vanilla-bean solids to 13.35 ounces of vanilla beans containing 25 percent moisture. (For example, one unit weight of vanilla beans containing 33.25 percent moisture amounts to 15 ounces.) The moisture content of vanilla beans is determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 7.004 and 7.005, which is incorporated by reference, except that the toluene used is blended with 20 percent by volume of benzene and the total distillation time is 4 hours.

Copies of the material incorporated by reference may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or click here.

If you are the careful type and want the National Archives or the Association of Official Analytical Chemists to weigh your vanilla beans for you, make sure your “pods are chopped into pieces approximately 1/4-inch in longest dimension, using care to avoid moisture change.”

The good news is that just four hundred years after Cortes introduced Spain to the sapid and odorous seed of the flowering orchid plant, in 1977, FDA declared vanilla extract, provided it meets all the requirements above, to be Generally Regarded as Safe (GRAS).

Kim Egan is Partner in the firm DLA Piper LLP

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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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