“Generational amnesia” about Raw Milk

Des Moines Register wrote about Mary McGonigle-Martin story, a mother who almost lost her son to an E. coli bacterial infection from raw milk. Mary McGonigle-Martin said, “The damage done by this bacteria is incomprehensible.”

McGonigle-Martin said she had believed natural-food enthusiasts’ claims that raw milk was healthier than unpasteurized milk. But the bacteria caused severe damage to her son’s kidneys and pushed him into heart failure. The boy, then 7, wound up on dialysis and needed surgeries. The ordeal, which began in 2006, led to more than $550,000 in medical bills.

“It is easy for people to be convinced that knowing your farmer and loving the cow will somehow magically prevent cow feces from getting into the milk,” she said. “We are all suffering from generational amnesia.”

Unpasteurized milk is 150 times more likely than pasteurized milk to cause foodborne illness. According to Dr. Ann Garvey, Iowa’s deputy state epidemiologist, people infected from consuming raw milk can pass the germs on to other people, who did not choose to eat or drink the untreated dairy products. For example, she said, an ill child from a family that drinks raw milk could spread bacteria to other kids in a child-care center.

Natural Almond Flavor and Allergen Labeling

[Emphasis added]

Here is a tricky question regarding the Food Allergen Labeling and Consumer Protection Act (FALCPA). "Tree nut" is not defined in the FALCPA, and the term is ambiguous because there are different uses for the term, "nut."  Most people know that peanuts, botanically, are not nuts but rather seeds. Similarly, almonds and pinyon seeds ("pine nuts") are not nuts botanically, but vernacularly they are referred to as nuts. 

On the other hand, annatto seeds are sometimes called nuts, but not routinely like pinyon seeds. FDA does not consider annatto to be a nut, so it is not treated as a major allergen under FALCPA.

Now let's get to the tricky part. Almonds are the seed of a tree closely related to peaches and apricots. For almonds, think of an ancient peach variety that was bred for the seed — the pit — rather than the fleshy fruit. So it is not surprising that peach pits and apricot pits have almond flavor. Consequently, most natural almond flavoring is derived from peach and apricot pits. (Yes the law permits it to be called "natural flavoring" because the flavor naturally occurs in the peach and apricot pits.) 

Under FALCPA if a product has almond-derived almond flavor, then almonds must be listed in the label's allergen statement. However, peach pits and apricot pits are not commonly thought of as tree nuts even though they are similar to almonds in many features and in being closely related. So for most people, the first reaction would be to exclude the peach pit and apricot pit from the allergen statement.

The dilemma arises because those who are allergic to almonds are known to sometimes have a cross-reaction to peach. It seems likely almond allergy could have a cross-reaction to peach pits and apricot pits. Yet, flavoring from peach and apricot pits could be hidden in a generic ingredient listing as "flavorings" or "natural flavorings". 

I asked FDA if it consider peach and apricot pits to be "tree nuts" for purposes of allergen labeling, but have received no response. FDA's interpretation is important because, if not considered tree nuts, then peach and apricot pits may not be listed in the "Contains" allergen statement. 

Nevertheless, the diligent manufacturer would want to inform consumers who might have an allergic reaction to peach or apricot pits. What would you suggest?

Save the Date: Summer Academy in Global Food Law and Policy

The Summer Academy in Global Food Law and Policy is a one-week summer program that brings together practitioners, policymakers, industry representatives, and leading academics working in the field of food law and policy. It offers intensive training on the most innovative developments in global food regulation and provides a unique opportunity for professional development and networking in an informal and interdisciplinary setting. By talking, studying, and interacting with food experts from all over the world, participants are able to gain new perspectives into both their own sectors and international regulatory issues. This is achieved by combining traditional classroom instruction with experiential learning opportunities offered by dedicated and distinguished international experts.

The 6th edition of the Academy will take place from Monday, 21 July, to Friday, 25 July, 2014, in Bilbao, Spain. The choice of this vibrant city will enable participants to benefit from the geographical location between the Atlantic sea and the Rioja region, as well as its distinctive architectural landscapes (with the Guggenheim Museum, Norman Foster's Underground, the towers by Arata Isozaki and César Pelli). For more information, please visit here.

The Summer Academy may be taken as a 3 credit, graduate-level course from Michigan State University.  Contact IFLR@msu.edu if you are interested in enrolling for graduate credit. If you wish only to attend as a seminar, enroll here.

FDA proposes "de-GRASing" artificial trans fat

The Food and Drug Administration today proposed measures that would virtually eliminate artificial trans fats. Based on new scientific evidence and the findings of expert scientific panels, the U.S. Food and Drug Administration (FDA) has tentatively determined that partially hydrogenated oils, which are the primary dietary source of industrially-produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives. Although FDA has not listed the most commonly used PHOs, they have been used in food for many years based on self-determinations by industry that such use is GRAS. If finalized, this would mean that food manufacturers would no longer be permitted to sell partially hydrogenated oils, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.

The Federal Food, Drug, and Cosmetic Act Turns 75

Seventy-five years ago on June 25, 1938, President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act.

Database of Dietary Supplement Labels

A database of labels of dietary supplements being sold in the United States is a joint project of the National Institutes of Health (NIH) with the National Library of Medicine The database information comes from the dietary supplement labels and may or may not be meet current requirements.

The database can be browsed or searched by key word, ingredients, product name, or claim language. NIH plans to eventually include most of the more than 55,000 dietary supplement products sold in the U.S., but the database currently contains about one third of the labels.

Last Chance to Register - Summer Academy in Global Food Law and Policy

The Summer Academy in Global Food Law and Policy is an established one-week summer program that brings together practitioners, policymakers, industry representatives, and leading academics working in the field of food law and policy. It offers intensive training on the most innovative developments in global food regulation and provides a unique opportunity for professional development and networking in an informal and interdisciplinary setting. By talking, studying, and interacting with food experts from all over the world, participants are able to gain new perspectives into both their own sectors and international regulatory issues. This is achieved by combining traditional classroom instruction with experiential learning opportunities offered by dedicated and distinguished international experts.

The 5th edition of the Academy will take place from Monday, 22 July, to Friday, 26 July, 2013 in Granada, Spain. The choice of this vibrant city will enable participants to benefit from the distinctive beauty of the town’s Unesco World Heritage environment and its privileged geographical location adjacent to the Sierra Nevada. For more information, please visit here.

The Summer Academy may be taken as a 2 or 3 credit, graduate-level course from Michigan State University.  Contact IFLR@msu.edu if you are interested in enrolling for graduate credit. If you wish only to attend as a seminar, enroll here.

Record-High Antibiotic Use for Animal Feed

In 2012 FDA proposed voluntary guidelines designed reduce antibiotics use in animal feed. There is scientific consensus that antibiotic use for growth promotion is inappropriate and should be ended. The Pew Charitable Trusts compared the numbers on antibiotic use on livestock farms to data on human use of antibiotics to treat illness. Their infographic appears below. 

Patent Rights, Exhaustion Doctrine, and Monsanto

On February 19, 2013, the Supreme Court heard oral arguments in Bowman v. Monsanto Co., involving an Indiana farmer who replicated Monsanto’s patented seeds them without paying the company a fee. Farmers who buy this patented seed must generally sign a contract promising not to save seeds from the resulting crop, which means the farmers must buy new seeds every year. Vernon Bowman had signed such contracts for his main crop but used what he thought was loophole: Rather than replant his own seed, he bought seed from a grain elevator filled with a mix of other farmers’ seeds.

The Roundup Ready soybean is the most popular variety in the U.S., so it was reasonably certain Bowman would receive mostly patented soybeans from the elevator. Mr. Bowman planted these seeds, then sprayed them with Roundup, so only the Roundup Ready soybean plants survived, and he saved those seeds for further plantings.

Mr. Bowman argued that the doctrine of patent exhaustion allowed him to do what he liked with products he had obtained legally. Under this doctrine, when an owner of intellectual property sells a copy of the property, the buyer is free to do what it wishes with the product. However, Justice Sonia Sotomayor noted, “The exhaustion doctrine permits you to use the good that you buy. It never permits you to make another item from that item you bought.”

The farmer’s lawyer said that companies could rely on contracts rather than patent law to protect their inventions. Justice Elena Kagan said, “It seems to me that that answer is purely insufficient in this kind of a case, because all that has to happen is that one seed escapes the web of these contracts, and that seed, because it can self-replicate in the way that it can, essentially makes all the contracts worthless.”

Justice Stephen G. Breyer said that there are lots of things someone could do with the seeds he had bought from the grain elevator. “You can feed it to animals, you can feed it to your family, make tofu turkeys … But I’ll give you two that you can’t do. One, you can’t pick up those seeds that you’ve just bought and throw them in a child’s face. You can’t do that because there’s a law that says you can’t do it. Now, there’s another law that says you cannot make copies of a patented invention.”

This intentional replication of the patented seeds infringes the patent, the same as someone makes thousands of copies of a CD he purchased. As Justice Breyer implied, this case really has nothing to do with the exhaustion doctrine and really is groping for a new doctrine or a new right for farmers to reproduce patented seed. This would make seed patents largely worthless.

As Chief Justice Roberts asked, “Why in the world would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?”

Listeria and soft-ripened cheese risk assessment

On Friday the U.S. Food and Drug Administration announced a draft quantitative assessment of the risk of listeriosis from soft-ripened cheese consumption in the United States and Canada. The risk assessment is a joint effort between FDA and Health Canada. View the Federal Register Notice for the assessment.

The new FDA/Health Canada draft risk assessment found that the risk of listeriosis from soft-ripened cheeses made with raw milk is estimated to be 50 to 160 times higher than that from soft-ripened cheese made with pasteurized milk. This finding is consistent with the fact that consuming raw milk and raw milk products generally poses a higher risk from pathogens than do pasteurized milk and its products.

While raw milk and raw milk products put all consumers at risk, the bacteria they may contain can be especially dangerous to people with weakened immune systems, older adults, pregnant women and children. View guidelines for avoiding illness by choosing milk and milk products carefully.

FDA invites comments that can help FDA and Health Canada improve:

·       the approach used;

·       the assumptions made;

·       the modeling techniques;

·       the data used; and

·       the clarity and transparency of the draft quantitative risk assessment documentation.

To submit comments electronically, go to docket FDA-2012-N-1182 on regulations.gov. The comment period opens February 11, 2013 for 75 days.

Improving Import Safety

Improving Import Food Safety presents diverse authors on the issues and difficulties involved in import food safety. The cases histories and factual information highlight both U.S. and international perspectives and provide insight for going forward.

Summer Academy in Global Food Law and Policy

The Summer Academy in Global Food Law and Policy is an established one-week summer program that brings together practitioners, policymakers, industry representatives, and leading academics working in the field of food law and policy. It offers intensive training on the most innovative developments in global food regulation and provides a unique opportunity for professional development and networking in an informal and interdisciplinary setting. By talking, studying, and interacting with food experts from all over the world, participants are able to gain new perspectives into both their own sectors and international regulatory issues. This is achieved by combining traditional classroom instruction with experiential learning opportunities offered by dedicated and distinguished international experts.

The 5th edition of the Academy will take place from Monday, 22 July, to Friday, 26 July, 2013 in Granada, Spain. The choice of this vibrant city will enable participants to benefit from the distinctive beauty of the town’s Unesco World Heritage environment and its privileged geographical location adjacent to the Sierra Nevada. For more information, please visit here.

The Summer Academy may be taken as a 2 or 3 credit, graduate-level course from Michigan State University.  Contact IFLR@msu.edu if you are interested in enrolling for graduate credit. If you wish only to attend as a seminar, enroll here.

Ackee Toxin: Natural, Added or Non-Added? Does It Matter?

FDA published a draft Compliance Policy Guide on ackee fruit that contain hypoglycin A, a toxin that can naturally occurs ackee. Adverse effects of consuming the toxin range from none to vomiting, seizures, and even death (a.k.a. Jamaican vomiting sickness).

Does this fall under the Food, Drug, and Cosmetic Act § 402(a)(1) non-added standard? — a food is deemed adulterated if it contains a poisonous or deleterious substance which may render it injurious to health?

Or does this fall under the § 402(a)(1) added substance standard? — a food is deemed adulterated if the quantity of the substance ordinarily renders it injurious to health?

In the case of ackee, deciding which standard to apply presents an interesting challenge. Unripe fruit contains hypoglycin A at high levels, but levels drop to negligible amounts in certain parts of the fruit as it ripens and splits open naturally. The toxin is naturally occurring but does that make it non-added under the FD&C Act? 

If the wrong parts of the fruit are used or if the fruit is not sufficiently ripe, levels of the toxin will be higher. Would this be “added” for purposes of a § 402(a)(1) analysis?

Ackees (Photo credit: kaiton)

To complicate matters further, methods can accelerate the appearance of ripeness, the splitting of the fruit, without the normal drop in the level of the toxin. Because human activity caused the fruit to have higher toxin levels than normal, would this be “added” for purposes of a § 402(a)(1) analysis?

Rather than wrestle with this issue, FDA pressed into service their ace in the hole, § 402(a)(4):

The presence of hypoglycin A in the finished ackee product at levels above 100 ppm can be attributed to improper processing of the product and may pose a health risk. . . .  Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C. 342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Canned ackee, frozen ackee, and other ackee products may be considered adulterated within the meaning of section 402(a)(4) of the FD&C Act when hypoglycin A is present in the food at levels greater than 100 ppm.

Hat tip to Ricardo Carvajal for his post on this topic. You may have heard of ackee fruit without realizing it. Listen carefully to the words of this song and image a visit to a tropical island.

Whale Barf, Perfume, and Biotechnology

The Morning Mail Is My Enemy

English: A family photograph of E. B. White, cropped from a photo of him and his wife. (Photo credit: Wikipedia)

From Letters of Note:  The Morning Mail is My Enemy

In March of 1961, nine years after the publication of Charlotte's Web, author E. B. White received a letter from a young fan named Cathy Durham who wanted to know when, if ever, his next children's book would see the light of day.

White hadn't written another book years after Charlotte's Web because answering fan mail had been taking up most of his time. 

What would E.B. White have thought of email?

Carbon Free Sugar?

Hmm?  

Table sugar is mostly sucrose, a disaccharide composed of the monosaccharides glucose and fructose. Sucrose has a molecular formula of C₁₂H₂₂O₁₁. Take away the carbon leaves us H₂₂O₁₁, basically the components for 11 water molecules.

http://www.dominosugar.com/carbonfree/#

Food Law Short Course & Seminar

Food Law Short Course & Seminar
	» Hurry, registration is limited Michigan State University - East Lansing, Michigan The program consists of two courses, a U.S. food law short course, and a food regulation current issues seminar. Participants may choose to take one or both. The courses are offered in a collegial, intimate learning environment. U.S. Food Law Short Course  July 16-17 (Monday-Tuesday) 2012 The U.S. Food Law Short Course is designed as an introduction to U.S. food laws and regulations for professionals in the field. It is well suited for those new to the field but also comprehensive enough on the essential elements of food law to provide a refresher course for the experienced professional. Food Regulation Current Issues Seminar   July 18-19 (Wednesday-Thursday) 2012 The Food Regulation Current Issues Seminar provides practical education on current food legal and regulatory issues. The topics cover cutting edge issues of food regulation, involving FDA, USDA, advertising, and global issues. Speakers from the legal, government, food industry, and academic professions will present practical food safety and food law information and case studies.   For more information, click here or  Register Online  Free Bonus U.S. Food Law Short Course participants will receive a copy of the book, Food Regulation: Law, Science, Policy, and Practice by Neal Fortin. The book provides an accessible discussion of the federal statutes, regulations, and agencies involved in food regulation in the United States. The Instructors David ACHESON, Partner at Leavitt Partners, former Assistant Commissioner for Food Protection, FDA Les BOURQUIN, Professor of Food Safety, Michigan State University Ricardo CARVAJAL, Attorney and Director, Hyman, Phelps & McNamara, P.C. Roger CLEMENS, Chief Scientific Officer, Horn; President, Institute of Food Technologists Nicole COUTRELIS, Lawyer and Partner, Coutrelis & Associes, Paris and Brussels Neal FORTIN, Attorney, Professor and Director, Institute for Food Laws and Regulations P. Vincent HEGARTY, Founding Director and Professor Emeritus, Institute for Food Laws and Regulation James E. HOADLEY, Senior Consultant, EAS Consultant Group Steve KLUTING, Attorney and Partner, Varnum, LLP Janine LEWIS, Principal Nutritionist, Food Standards Australia New Zealand Scott J. MACINTYRE (invited), District Director, U.S. Food and Drug Administration Kenneth ODZA, Corporate Counsel, Food Safety, Kellogg Company F. Edward SCARBROUGH, Principal, Scarbrough Consultants, former U.S. Manager for Codex and Director Jenny SCOTT (invited), Senior Advisor, Office of Food Safety, FDA CFSAN John SPINK, Director, Packaging for Food and Product Protection Initiative, MSU Steve STEINBORN, Attorney and Partner, Hogan Lovells, US, LLP Charles WOODHOUSE, Attorney and Partner, Woodhouse Shanahan PA Cathy WEIR, Global Regulatory Associate Director, Mead Johnson Nutrition Gerald WOJTALA, Executive Director, International Food Protection Training Institute  About IFLR  Learn more about IFLR at: www.IFLR.msu.edu or call (517) 355-8295       Email: IFLR@msu.edu                       Telephone: (517) 355-8295 Fax: (517) 432-1492                        web: www.IFLR.msu.edu   Institute for Food Laws and Regulation Michigan State University, 139 G.M. Trout Building, East Lansing, MI 48824

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Subscribe to the IFLR mailing list

ABA Food and Supplements Conference will be held on Tuesday, June 12th, at Sara Lee in Chicago.  There is a great conference agenda that promises to be a lively and enjoyable event.   You may read the brochure here.   Registration for the conference is now open.  The last one sold out.

Domestic Facility Risk Categorization and Risk-Based Inspection Frequencies

The FDA Food Safety Modernization Act (FSMA) created section 421 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates FDA inspection frequency based on risk for domestic food facilities that are required to register under FD&C Act section 415. Specifically, section 421 mandates inspection frequencies based on a facility being identified as high-risk (HR) or non-high-risk (NHR). HR facilities must be inspected at least once in the first 5 years following enactment of FSMA and then once every 3 years. NHR facilities must be inspected at least once in the first 7 years following enactment and then once every 5 years. These inspection frequencies are a minimum and some firms may be inspected on a more frequent basis. 

FDA estimates the inventory for high-risk facilities at 22,325 and non-high-risk at 60,000.  For FY 2012, approximately 7,400 HR and 8,600 NHR facilities are planned for inspections. FDA plans to inspect HR facilities every 3 years although the new legislation provides an initial frequency mandate of inspecting each HR facility once in a 5-year period

Factors in Risk Categorization (FY 2011-13)

FSMA Identified Risk Factors*	Data Elements
Known safety risks of the food	Class 1 Recalls** Foodborne illness outbreaks
Compliance history of a facility	Inspection Classifications Facilities with significant violations Facilities with a history of non-compliance
Facility’s hazard analysis and risk-based preventive controls	Limited data
Priority under section 801(h)(1)	Applicable to foreign facilities only
Certifications for imported food	Programs not yet established
Any other criteria deemed necessary	Type of activity (establishment type) Years since last inspection

Adapted from FDA, FSMA Domestic Facility Risk Categorization (FY 2012). 

The risk categorizations are expected to evolve as FDA gathers data on the new risk-based preventive controls and certifications are developed for imported foods.  The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls will be an important factor in the future. At this time, FDA is basically determining risk in a three step process based on some of the above factors:

1. Known safety risks of the food - Whether facility packs, processes or holds a commodity that has been identified with known food safety risks; that is, food commodities associated with outbreaks and/or Class-I recalls.

2.  Years since last inspection. 

3.  Compliance history - History of significant violations or non-compliance.

AeroShot “Caffeine Inhaler”

FDA issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their “caffeine inhaler.” FDA finds the labeling false or misleading because the company claims use for both inhalation and ingestion. Breathable Foods claims AeroShot is designed to provide “breathable energy, anytime, anyplace.” The company also claims that its product is intended to be ingested by swallowing. FDA states that a product cannot be intended for both inhaling and swallowing, noting that human anatomy does not permit simultaneous inhalation and ingestion.

FDA continues that, “By definition, dietary supplements must be intended for ingestion.” See FDCA §§  201(ff)(2)(A) and 411(c)(1)(B) [21 U.S.C. §§ 321(ff)(2)(A) and 350(c)(1)(B)].  “A product intended for inhalation is not a dietary supplement.” Surprisingly, FDA did not state the consequence of failing to be a dietary supplement — as far as it is intended for caffeine inhalation, Aeroshot would be a drug and medical device.  I cover this in my book, Food Regulation: Law, Science, Policy, and Practice, in discussion of the case, United States v. Ten Cartons of Ener-B Nasal Gel.       

FDA is also concerned about AeroShot’s because of questions about its safety. Terms such as “caffeine inhaler” and “breathable energy” may encourage consumers to try to inhale AeroShot into their lungs. Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied.  

The FDA also expressed concern about the use of AeroShot by children and adolescents.  The company’s website indicates that AeroShot is “not recommended for those under 18 years of age,” but the product label states that it is “not intended for people under 12.”  

FDA is also concerned about AeroShot website links to news articles and videos that refer to use of the product in conjunction with drinking alcohol.  While using caffeine when drinking may lead consumers to feel “less drunk,” it does not reduce blood alcohol levels. FDA states, “Data and expert opinion also indicate that caffeine decreases the perception of intoxication, meaning that individuals who consume caffeine along with alcohol may consume more alcohol than they otherwise would and become more intoxicated than they realize. At the same time, caffeine does not change blood alcohol content levels, and thus does not reduce the risk of harm associated with drinking alcohol.”

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius.