Food Law Prof Blog

JUNK FOOD LEADS TO PRISON?

Oxford University Professor John Stein and a team of scientists plan to study the whether the increase in the consumption of junk food in the last fifty years has lead to more violent behavior in young adults. From a January 29, 2008, article in The Independent:

Professor Stein and “[t]he university will lead the £1.4m study in which
1,000 males aged 16 to 21 from three young offenders' institutions in England and Scotland will be randomly allocated either the vitamin-and-mineral supplements or a placebo, and followed over 12 months.”

In a pilot study of 231 prisoners by the same researchers, published in 2002, violent incidents while in custody were cut by a more than a third among those given the supplements. Overall, offences recorded by the prison authorities fell by a quarter.”

Link to press release from the research charity the Wellcome Trust.

Thank you to William Mitchell College of Law student Matthew Dudas for preparing this post.

Dietary Supplements Siezed because of health claims

From an FDA news release:

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized on Tuesday approximately $71,000 of goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.

Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims are evident in the products' labeling, including promotional literature and FulLife's Internet Web site.

The agency takes seriously its responsibility to protect Americans from unapproved drugs. FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. Tuesday's action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.

FDA Issues Dietary Supplements Final Rule

FDA News Release:

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

Cocaine Energy Drink: Food, Drug, or None of these?

From ABC News:

[An energy drink  -- "Cocaine" --] contains no actual cocaine, but is being marketed as "The Legal Alternative" to the illegal drug, according to its Web site. Its logo appears to be spelled out in a white powder that resembles the drug.

The Food and Drug Administration said Redux Beverages LLC is illegally marketing the drink as both a street drug alternative and a dietary supplement, according to a warning letter dated April 4 but publicly released Wednesday. The FDA cites as evidence the drink's own labeling and Web site, which include the statements "Speed in a Can," "Liquid Cocaine" and "Cocaine — Instant Rush," according to the letter.

Functional Foods in Europe

From NPICenter: A food supplement industry group, the European Botanical Forum, has recently developed a safety evaluation model for possible use in used in future regulation of botanicals under food law. 

Botanicals include fruit and vegetables, herbs and spices, herbal teas and infusions, herbs added to foods and beverages for taste or functional purposes and botanical food supplements. Many botanicals however, also have medicinal uses, making the task of determining which legal framework applies to which product difficult.

“Safety is key,” stated Dr Manfred Ruthsatz, Chairman of the European Botanical Forum.  “The aim of the negative list is to provide a document that is widely acceptable across the 27 EU member states to allow safe applications under food law on the principle that if there is no safety risk there should [not] be any regulation. The inclusion of botanicals into negative lists, however, should be considered with care since it would preclude use of the botanical entity for all food applications whereas the safety of derivatives, extracts or isolates can be frequently demonstrated.”

The model is a response to European Parliament action last Spring regarding Functional Foods and nutritional supplements.  More on  European functional foods regulation: Herbalgram.org

The 2006 Dole Spinach E. coli 0157:H7 Outbreak of 2006 on MarlerBlog

Bill Marler has posted an article on his Marler Blog detailing the developments of the 2006 bagged spinach E. coli 0157:H7 outbreak and placing the outbreak in the context of earlier produce-related E. coli outbreaks.

E. coli O157:H7 outbreaks associated with lettuce or spinach, specifically the "pre-washed" and "ready-to-eat" varieties sold under various brand and trade names, are by no means a new phenomenon. . . .The Center for Science in the Public Interest found that, of 225 food-poisoning outbreaks from 1990 to 1998, nearly 20 percent (55 outbreaks) were linked to fresh fruits, vegetables, or salads.

Last fall's spinach-sourced E. coli 0157:H7 outbreak, was traced to spinach grown by Natural Selection Foods (aka Earthbound Farm) and marketed by Dole, according to the article.  This makes me realize how truly ignorant I am.  Natural Selection Foods provides produce to some 20 different labels.  Were all the tainted samples Dole because the unlucky lot of spinach happened to be going to Dole?  Does Dole have any role in the actual packaging?  So much yet to learn! 

Blurring the Food-Drug line: Nestle buying unit of Novartis

Whatever happened to real food?  Food giant Nestle is adding to its ability to sell products that kind of look like food, but have the characteristics of nutritional supplements.  Nestle has agreed to buy a unit of Novartis, one of the largest makers of nutritional supplements.  Earlier this year Nestle bought Jenny Craig and Uncle Tobys, a cereal bar producer. 

This move makes sense as the baby boom generation ages and medical problems increase.  This new acquisition will make Nestle the second largest maker of nutritional supplements for hospitals.

Sales of nutritional food are increasing as much as 8 percent a year, compared with 1 percent to 2 percent for the broader food market, according to Kepler Equities. Nestle has sold divisions valued at more than $1 billion that process cocoa and coffee and make food ingredients.

The Novartis unit makes Boost drinks, designed to bring proteins, minerals and vitamins to people with ailments ranging from anorexia to cancer and to aid digestion. It also makes Nutrament energy-drink and Optifast weight-loss products. It has 2,000 employees and operates in 40 countries.

The Chicago Tribune article continues