This just in from the FDA:

September 2005 (#10)

IN THIS ISSUE:

1. FDA’s Letter to Food Manufacturers on “and/or” Ingredient Labeling of Nutritive Sweeteners in Soft Drink Products. July 5, 2005

2. FDA issues Nationwide Alert for “Liquang 4” due to potential health risks, July 1, 2005

3. FDA letters regarding qualified health claims:
Green tea and certain cancers, June 30, 2005
Chromium picolinate and insulin resistance, August 25, 2005

4. FDA Food Advisory Committee meeting on food allergens and gluten, July 13-14, 2005

5. FDA public meeting on the term “gluten-free” in food labeling, August 19, 2005

6. Upcoming Codex Committee meeting on nutrition and fords for special dietary uses, October 18, 2005

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
FOOD LABELING AND NUTRITION
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

1. FDA’s Letter to Food Manufactures about “and/or” Ingredient Labeling of Nutritive Sweeteners in Soft Drink Products.

FDA received several inquiries regarding the status of “and/or” ingredient labeling of nutritive sweeteners in soft drink products in light of the November 26, 2004 Federal Register (FR) Notice (69 FR 68831) withdrawing the proposed rule to permit “and/or” labeling for nutritive sweeteners in soft drinks.

In general, the ingredients of a multi-ingredient food must be declared on the food label by their common or usual names; FDA may grant exemptions to this requirement based on a finding that compliance is impracticable or will result in deception or unfair.

~~~~~~~~~~~~~~~~~~~~~
DIETARY SUPPLEMENTS
~~~~~~~~~~~~~~~~~~~~~

2. FDA issues Nationwide Alert for “Liquang 4” due to potential health risks, July 1, 2005

FDA is warning consumers not to take Liqiang 4 capsules, which are illegally labeled and marketed as a dietary supplement. This product contains glyburide – a drug that could have serious, life-threatening consequences in some people.

3. FDA has issued two decision letters for qualified health claim petitions in the form of a letter of enforcement discretion for: Green tea and certain cancers, June 30, 2005

On June 30, 2005, FDA issued a decision letter for qualified health claims for the relationship between green tea and the reduced risk of breast cancer and for the relationship between green tea and a reduced risk of prostate cancer. FDA intends to consider exercising enforcement discretion for the following qualified health claims:

1. “Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.”

2. “One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.”

The petition also requested other qualified health claims that were denied by FDA because there was no credible evidence. The denied qualified health claims were for the relationship between the consumption of green tea and reduced risk of gastric cancer; lung cancer; colon/rectal cancer; esophageal cancer; pancreatic cancer; ovarian cancer; liver cancer; bladder cancer; and skin cancer, as well as total cancers combined.

Chromium picolinate and insulin resistance, August 25, 2005

On August 25, 2005, FDA issued a decision letter for a qualified health claim for the relationship between chromium picolinate and a reduced risk of insulin resistance. FDA intends to consider exercising enforcement discretion for the following qualified health claim:

“One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.”

The petition also requested other qualified health claims that were denied by FDA because there was no credible evidence. The denied qualified health claims were for the relationship between the consumption of chromium picolinate and a reduced risk of: cardiovascular disease when caused by insulin resistance; abnormally elevated blood sugar levels; cardiovascular disease when caused by abnormally elevated blood sugar levels; cardiovascular disease when caused by type 2 diabetes; retinopathy when caused by abnormally high blood sugar levels; and kidney disease when caused by abnormally high blood sugar levels.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
PUBLIC MEETINGS & HEARINGS
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

4. The FDA Food Advisory Committee met on July 13-14, 2005, to evaluate the Center for Food Safety and Applied Nutrition Threshold Working Group’s draft report, “Approaches to Establish Thresholds for Major Food Allergens and Gluten.” Documents related to this meeting can be found at http://www.fda.gov/ohrms/dockets/ac/cfsan05.html

5. FDA held a public meeting August 19, 2005, to obtain expert comment and consultation from stakeholders to help the agency to define and permit the voluntary use on food labeling of the term “gluten-free”. The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. The Federal Register notice for this meeting can be found at http://www.cfsan.fda.gov/~lrd/fr050719.html

6. On October 18, 2005, the USDA and FDA will sponsor a public meeting to provide information and receive public comments on agenda items and draft U.S. positions that will be discussed at the 27th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses
(CCNFSDU) of the Codex Alimentarius Commission (CODEX). View the meeting announcement
(http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/05-006N.htm)

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.