Monday, April 07, 2014

GRAS: Generally Recognized As Secret?

The Natural Resources Defense Council (NRDC) issued a report that raises more questions about the US regulatory system for food additive. The report says the GRAS exemption from food additive review by FDA — “generally recognized as safe” — that intended for common food ingredients “has been stretched so most new chemicals pass through it: the loophole has swallowed the law.”

NRDC believes that “Generally Recognized as Secret” rather than “Generally Recognized as Safe” is a better name for the GRAS loophole. A chemical cannot be “generally recognized as safe” if its identity, chemical composition, and safety determination are not publicly disclosed. If the FDA does not know the identity of these chemicals and does not have documentation showing that they are safe to use in food, it cannot do its job.

A PDF of the report is available here.

A summary of the report follows:

Tuesday, March 04, 2014

FDA Reopens Comment Period on "Evaporated Cane Juice"

The Food and Drug Administration is reopening the comment period on its draft guidance for industry on declaring "evaporated cane juice" as an ingredient on food labels.  The agency originally published the guidance in October of 2009 and accepted comments through early December of that year. 

The draft guidance advises industry of FDA's view that sweeteners derived from cane syrup should not be listed on food labels as evaporated cane juice because the sweetener is not juice as juice is defined in Federal regulations (Title 21 of the Code of Federal Regulations, Section 120.1(a)). 

FDA is reopening the comment period for 60 days to obtain additional data and information to better understand the basic nature and characterizing properties of the ingredient, the methods of producing it, and the differences between this ingredient and other sweeteners.

Interested parties may submit comments by written letter or electronically starting March 5, 2014. Additional information, including directions for filing comments and the final due date for comments, is available in the Federal Register notice announcing reopening of the comment period.  

Tuesday, February 11, 2014

“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.

Thursday, January 23, 2014

Natural Almond Flavor and Allergen Labeling

ingredient statement with natural almond flavor
[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?

Thursday, November 21, 2013

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 C├ęsar 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.

Thursday, November 07, 2013

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.

Wednesday, June 26, 2013

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.