Raw Milk

March 10, 2011

What’s a building block in the food pyramid that’s important for building and maintaining bone mass? It’s milk. Whether it’s from cows, goats, sheep, or another mammal, milk and milk products are an important source of calcium throughout a person’s life.

Most of the milk sold in the United States is pasteurized, a process during which the milk is heated to 161 degrees and kept there for 15 seconds. Pasteurization kills harmful bacteria—including salmonella, E. coli, and listeria—that can contaminate milk before it gets to your table.

Milk Pasteurization

Pasteurization of milk is an effective means of preventing outbreaks of foodborne illness, including tuberculosis, brucellosis, salmonellosis, scarlet fever, and listeriosis. It was first used in the United States more than 100 years ago and has been widely used for more than a half-century, says John Sheehan, an FDA expert on the safety of dairy products. But increasingly, consumers are seeing “raw” milk—and cheeses, yogurts, and other products made from it—in specialty shops, farmers’ markets, and stores.

Although the heating process slightly affects a few of the vitamins—thiamine, vitamin B6 and folic acid within the B-complex, and vitamin C, the changes are not significant. Meanwhile, there is a risk that milk could be contaminated by environmental factors such as soil or animal feces, animal diseases, or bacteria on an animal’s skin.

In countries where pasteurization of milk is less common, outbreaks of foodborne illness attributed to tainted milk or milk products occur more frequently than they do in the United States. In France, for example, the rate of foodborne illness attributed to milk and milk products was reported to be roughly three times what it is in the U.S., citing a 2001 study by researcher Marie-Laure De Buyser and other French scientists.

FDA and Rare Diseases

March 2, 2011

FDA is in a unique position to help those who suffer from rare diseases. The agency’s rare disease initiatives include the following:

  • FDA’s Office of Orphan Products Development gives grants to further the development of drugs, biologics (such as vaccines or blood products), medical devices, and medical foods for the treatment of rare diseases. (Medical foods are specially made and processed foods, used under a health care professional’s supervision, to meet a patient’s distinctive nutritional requirements.)
  • FDA plays an important role in granting orphan designations and marketing approvals for drugs, biologics, and medical devices to treat rare diseases. Designating a potential product as “orphan” encourages companies to develop that product by giving them financial and other incentives.
  • FDA’s Office of New Drugs within the Center for Drug Evaluation and Research established the Rare Diseases Program to assist and support the research, development, regulation, and approval of drug and biologic products for the treatment of rare disorders.
  • As countries combine their efforts to spotlight “Rare Diseases and Health Inequalities,” FDA continues to collaborate with international regulatory agencies to address unmet medical needs of patients with rare diseases globally. FDA’s Office of Orphan Products Development and the European Medicines Agency (EMA) work together regularly and have a common application for orphan product designation.
  • FDA advocates for rare disease awareness and treatments through work with patients and patient organizations.