Thursday, November 15, 2012

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
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.

Thursday, October 11, 2012

The Morning Mail Is My Enemy

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

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/#

Monday, September 17, 2012

Pink Slime Fights Back

Beef Products, Inc., (BPI) has announced a $1.2 billion lawsuit against ABC et al. regarding alleged defamation of its lean finely textured beef (LFTB) product (a.k.a. “Pink Slime”). The complaint is available here. LFTB is produced by separating lean beef from beef trimmings. Just one aspect of many in the complaint is a disagreement over whether the basic nature of LFTB.
What do you think?
 Do you consider LFTB, aka pink slime, to be “meat”?
Is lean finely textured beef (LFTB) an accurate descriptive name for this product?
Click here to take survey
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Tuesday, May 29, 2012

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


 If you would like to be sure of receiving future IFLR announcements:
Subscribe to the IFLR mailing list

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Case Filings and Oral Arguments Posted on the Patient Protection and Affordable Care Act Cases

The Supreme Court of the United States (SCOTUS) heard oral arguments regarding the Patient Protection and Affordable Care Act (PPACA) cases, Department of Health and Human Services v. Florida, on March 26 through 28, 2012. The case filings and oral arguments are now posted.

Wednesday, May 09, 2012

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.

Friday, March 23, 2012

Superbug Ruling: FDA Must Withdraw Some Antibiotics in Feed

In NRDC v. FDA, yesterday Judge Theodore H. Katz, U.S. District Court, S.D. N.Y., ordered the FDA to begin withdrawal proceedings to remove two drugs, penicillin and tetracyclines, from animal feed unless industry can document that that use is safe.  Such non-therapeutic use of medically important antibiotics contributes to the problem of antibiotic-resistant bacteria

Sunday, March 18, 2012

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

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.

Wednesday, March 07, 2012

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

Sunday, February 26, 2012

"Soy Torture" of Prisoners


The Weston Price Foundation is backing lawsuits by prison inmates being poisoned, tortured, and irreparably harmed — by soy in the prison food.  For years, rumors floated about of saltpeter in prison diets. Mel Brooks made jokes about it.  But now — soy in prison diets! Among other things, soy has been accused of causing low sperm counts.

The lawsuits allege that the soy caused acne, insomnia, weight gain, and additional ailments.  As such, the complainants say soy in the prison diet is cruel and unusual punishment in violation of their Eighth Amendment rights.  

I am not making this up.  See, Askin v. Quaker Oats Co., No. 1:11CV00111 2011, WL 145369 (N.D. Ill. Jan. 7, 2011) and Weston A. Price Foundation Press Release, Oct. 25, 2011. 

Soy vey!

Friday, February 24, 2012

FDA's New Record Access Authority


FDA published an Interim Final Rule to modify their regulations on the establishment, maintenance, and availability of records. Before passage of the Food Safety and Modernization Act (FSMA), section 414(a) of the FD&C Act provided the Secretary of Health and Human Services (and by delegation FDA) with access to records relating to food that was reasonably believed to be adulterated and present a threat of serious adverse health consequences or death to humans or animals. FSMA expanded FDA’s records access authority to records relating to include any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner and foods which FDA considers a reasonable probability that the use of or exposure to the article of food will cause serious adverse health consequences or death to humans or animals. 

Although the majority of the rule tracks the FSMA language, one important addition has been made.  Records are required to be “provided must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request.”   

21CFR § 1.361 What are the record availability requirements?
When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.

FDA’s record access authority under section 414 is separate from previously existing records access authority provided in commodity specific regulations, such as the Low-Acid Canned Food regulations (21 CFR part 113), the Acidified Food regulations (21 CFR part 114), the Juice Hazard Analysis and Critical Control Point (HACCP) Systems regulations (21 CFR part 120), the Fish and Fishery Products regulations (21 CFR part 123), and the Infant Formula regulations (21 CFR part 106). FSMA did not amend these commodity specific record access requirements.  

FDA’s records access authority under sections 414(a) and 704(a) applies to both domestic and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import articles of food when the circumstances in section 414(a)(1) or (2) of the FD&C Act are met. 

FDA requests to access and copy records are most likely to occur when FDA becomes aware of reportable food reports, as defined in section 417(a)(2) of the FD&C Act [21 U.S.C. 350f(a)(2)], foodborne outbreaks, epidemiological evidence implicates a food causing illness or death, product recalls, adverse event reports, and consumer complaints.

FDA’s authority under FD&C Act §§ 414(a) and 704(a) applies to records that are required to be kept by regulation under section 414(b), as well as any other records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the food believed to be affected and any other article of food believed to be affected in a similar manner.  Examples of records that FDA can access and copy include:
       Manufacturing records
       Raw materials (ingredients and packaging) receipt records
       Product distribution records
       Product inventory records
       Test records
       Recall records
       Reportable food records      
       Customer distribution lists
       Complaint and adverse event records

FDA's authority to access records under sections 414(a) and 704(a) of the FD&C Act does not apply to records from farms, as defined in 21 CFR 1.328, records from restaurants, as defined in 21 CFR 1.328, or records relating to food that is within the exclusive jurisdiction of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.)  FDA's authority to access records also does not apply to:
·      Recipes, as defined in 21 CFR 1.328 (but a list of the ingredients used to manufacture a food, without quantity information and manufacturing instructions, is not a recipe.)
·      Financial data
·      Pricing data
·      Personnel data
·      Research data
·      Sales data other than shipment data regarding sales 

The refusal to permit access to or copying of records requested under section 414(a) of the FD&C Act is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. In response to such a refusal, FDA may initiate civil or criminal action, as necessary, including:
       Suspension of the food facility’s registration, thus preventing the firm from importing or exporting food or introducing food into interstate or intrastate commerce
       Administrative detention of the food to control its movement
       Seizure of the food
       Issuance of a mandatory recall order for the food
       Injunction against the firm 
       Refuse admission of food offered for import into U.S. commerce
FDA has issued two guidance documents:



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

    Monday, February 06, 2012

    Federal Meat Inspection Act Preempts California Law on Non-Ambulatory Animals


    In a unanimous opinion, the U.S. Supreme Court held that the Federal Meat Inspection Act (FMIA) expressly preempts a California law that dictated slaughterhouses must reject non-ambulatory pigs.

     The California law, section 599f of the California state penal code, prohibited slaughterhouse purchase or sale any non-ambulatory livestock and prohibited the processing of meat from non-ambulatory livestock for human food. This law was adopted in 2008 after the Humane Society released an undercover video showing workers at a Westland/Hallmark Meat Co. slaughterhouse in California dragging, kicking, and electro- shocking sick and disabled cows in an effort to move them. The video led the federal government to institute the largest beef recall in U. S. history in order to prevent consumption of meat from diseased animals.

    First enacted in 1906, the FMIA was amended in 1978 to require all slaughterhouses comply with the standards for humane handling and slaughter of animals set out in the Humane Methods of Slaughter Act of 1958 (72 Stat. 862, 7 U.S.C. §1901 et seq.). The FMIA express preempts state laws “with respect to premises, facilities and operations of any establishment at which inspection is provided under . . . this [FMIA] which are in addition to, or different than those made under [FMIA]” (21 U. S. C. § 678).

     “The FMIA’s preemption clause sweeps widely—and in so doing, blocks the applications of §599f challenged here. The clause prevents a State from imposing any additional or different—even if non-conflicting—requirements that fall within the scope of the Act and concern a slaughterhouse’s facilities or operations. And at every turn §599f imposes additional or different requirements on swine slaughterhouses: It compels them to deal with nonambulatory pigs on their premises in ways that the federal Act and regulations do not. In essence, California’s statute substitutes a new regulatory scheme for the one the FSIS uses. Where under federal law a slaughterhouse may take one course of action in handling a nonambulatory pig, under state law the slaughterhouse must take another.” 565 U. S. ____ (2012).


    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

    Thursday, January 12, 2012

    Get Poisoned for Free


    Bill Marler, guest instructor for the Institute for Food Laws and Regulations, is offering to give a book to each new person who subscribes to his blog (up to 200 hardcover books).  Just subscribe here and email Mr. Marler your address at bmarler@marlerclark.com.

    The book, Jeff Benedict's Poisoned, is a great read.  So is Bill Marler's blog. Win Win.