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FDA warns public vs 'colostrum food' milk powder


Health authorities warned the public against a skim milk powder that claims to have colostrum along with therapeutic and health benefits.

The Food and Drug Administration, in Advisory 2013-039, particularly cited "false, misleading and deceptive" health claims by IgCo Skim Milk Powder.

"The case is now under investigation and the company is requested to cooperate with the field Food and Drug Regulation Officers under the Field Regulatory Operations Office," FDA head Kenneth Hartigan-Go said.

While the FDA advisory was dated Oct. 2, it was posted on the FDA website early this week.

He added IgCo Skim Milk Powder with natural colostrum is a food product but the FDA "did not approve any health and curative or therapeutic claims" when it issued a Certificate of Product Registration (CPR) to SNI Philippines, Inc.

According to Hartigan-Go, the makers of the product made therapeutic claims about the product, including:


- decrease infection rate among cancer patients undergoing chemotherapy
- speed up recovery time from dengue infection
- delay the signs of aging
- boost the immune system
- lessen inflammation and pain in patients with arthritis
- help in lowering blood sugar to normal level
- alleviate the signs and symptoms of skin allergy
- lessen episodes of asthmatic attacks
- prevents colds, cough, and flu
- burn unwanted fats and build lean muscle mass
- improve the quality of sleep

Yet, Hartigan-Go said there was no scientific study and clinical trial to back up all its claims.

Logo used without FDA approval

Hartigan-Go also noted the Bureau of Food and Drugs/FDA Logo is being used in advertisement materials of "IgCo Natural Colostrum" without FDA approval.

This violates FDA Memorandum Circular No.2013-030, which prescribes guidelines on the use of the FDA Logo in promotional and advertisement materials, he said.

An initial check showed IgCo Skim Milk Powder was granted a Certificate of Product Registration (CPR) to SNI Philippines, Inc. on Feb. 28, 2011 with Food Registration (FR) No.74217, which is valid until September 19, 2015.

On the other hand, he said the distributor made claims the product is the first colostrum food in the Philippines.

Human colostrum or first milk is only produced by expecting mothers in their late pregnancy and the first few days after giving birth, and breast milk produced by mothers is the only complete food for babies.

Also, colostrum is high in carbohydrates, high in protein, high in antibodies, and low in fat, as human newborns may find it difficult to digest the large fat globules of cow's milk.

But Hartigan-Go said it is "misleading to claim or even imply that highly processed cow's skim milk powder contains special components, immune factor, growth modulators and other health promoting substances, that could possibly health the full-term and premature babies fight infections and other diseases without first undertaking clinical trials."

In the meantime, he urged the company to "review its promotional and advertisement materials" in light of the Milk Code or the National Code of Marketing of Breast-milk Substitutes, Breast-milk Supplements and Other Related Products.

He also urged the public to report food products making such curative or therapeutic claims at report@fda.gov.ph, or seek more information via info@fda.gov.ph. — LBG, GMA News