FDA & USDA Related Articles

Final Rule on Use of Cattle Materials in Food & Cosmetics: Record Keeping Requirements

In an effort to protect consumers from bovine spongiform encephalopathy (BSE), otherwise known as “Mad Cow Disease”, the FDA has issued a final rule regarding the use of “prohibited cattle materials” in human food and cosmetics.  Because there are no reliable tests for the BSE agent itself, FDA has concluded that it needs to rely on the records of manufacturers and processors to demonstrate that FDA-regulated products are free from “prohibited cattle material.” Therefore, the rule requires manufacturers and processors of human foods and cosmetic products that are manufactured from, processed with, or otherwise contain material from cattle to establish and maintain records sufficient to demonstrate that such products are not manufactured from, processed with, or do not otherwise contain “prohibited cattle materials.” Such records must be available to FDA for inspection and copying and must be retained for two years after the date they were created. This recordkeeping requirement applies to manufacturers and processors of finished products, food ingredients, food additives, and dietary ingredients for use in dietary supplements. The final rule also imposes new requirements with respect to the importation of human foods and cosmetics that are manufactured from, processed with, or otherwise contain cattle material.

The final rule will become effective on 01/27/2007.


Presenting the New Qualified Health Claim: Canola Oil

The FDA has authorized a qualified health claim relating to the consumption of unsaturated fatty acids from canola oil and its connection to a reduced risk of coronary heart disease.  Conventional foods eligible to bear the qualified health claim are limited to canola oil and certain canola oil products, specifically vegetable oil spread, dressings for salads, shortenings, and canola oil-containing foods.  The qualified health claim provides as follows:

 “Limited and not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (19 grams) of canola oil daily may reduce the risk of coronary heart disease due to the unsaturated fat content in canola oil. To achieve this possible benefit, canola oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of canola oil.”

If you would like further information regarding this or any other qualified health claim, please contact Allan Zackler.


USDA Conundrum: What is Organic Fish?

Proposed USDA guidelines which would allow certain farm fish to be called “organic” have become a source of controversy--even amongst the groups who were thought to be its biggest supporters.  In its proposal, the USDA describes an organic fish as one that eats either a) an entirely organic diet or b) a nonorganic fish meal from sustainable fisheries or c) nonorganic fish while the fish farm is in transition to organic fish meal. To the dismay of fishermen, the proposal essentially disqualifies wild-caught fish from the “organic” label because their living conditions and diet are not controlled.  Environmentalists, on the other hand, argue that farm-raised fish cannot be labeled “organic” because they live in cramped conditions which may pollute the water. Meanwhile, many who favor the USDA’s designation of “organic” for farmed fish cannot agree on the types of fish which should be included.  There is broad agreement that the organic label is no problem for fish that are primarily vegetarians, like catfish and tilapia, because organic feed is available.  Carnivores like salmon, however, are a different matter because they eat other fish which are not labeled organic.  The USDA proposal baffles many connected with the fishing industry since wild fish living in pristine waters are favored by fish lovers.  “If you can’t call a wild Alaska salmon true and organic,” asked Alaskan Senator Lisa Murkowski, “what can you call organic?”  At stake is more than the right to label fish “organic”: in 2005, sales for organic products reached $13.8 billion.  Those who make a living catching and selling wild fish worry that the “organic” label will give fish farmers a huge advantage in the battle for the consumer’s dollar.



New Health Claim: Low Fat Diets and the Risk of Heart Disease

The FDA has authorized the following new health claim regarding the consumption of saturated fat, trans fat, and cholesterol and the reduced risk of heart disease. 

“Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease.”

To qualify for the health claim, the food must be (a) “low in saturated fat” and “low cholesterol”, (b) contain less than 0.5 g of trans fat per RACC or meet any definition of “low trans fat” that FDA may establish in the future, (c) contain less than 6.5 g of total fat per RACC, and (d) comply with all the general requirements for health claims set forth in 21 CFR §101.14.  The health claim went into effect on November 15, 2006.