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