The FDA Takes on the Food Safety Policing Role (Soon?)

Sick from Food? Not Rare Anymore

People from the place I grew up used to joke about the food that sold by street vendors: not clean enough but won’t get you sick.  Most of the time, the food materials were produced locally and prepared right in front of you; if you don’t feel comfortable about the sanitary condition of the food preparation process, you just don’t buy it.  If you do get sick, though it was not that common, come back to complain and ask for improvement or compensation.  Most food vendors operate on the ethical and moral basis–make food for the customers the way they make their own food.  Good reputation will serve their small businesses well by word-of-mouth.  Now, time has changed.  With the industrialization of food production and distribution, food-borne illnesses have increased in the numbers of outbreak and on a bigger and broader scale.  Recent Salmonella contaminated eggs causing nearly 2000 illnesses is just the tip of the iceberg.

Something about Legislation You Need to Know

On 30 November, the US Senate passed a law on food safety that renders the U.S. Food and Drug Administration (FDA) a bigger muscle to stop unsafe food reaching to consumers.  Although the food safety bill was passed by the US Senate, it may or may not eventually become a law.  According to Nature News, the food safety bill will require further negotiation between the Republicans and Democrats.  Go figure!

The bill could conceivably be defined to raise taxes, by imposing fees on food importers and on domestic manufacturers whose food is subject to a recall when it is discovered to be tainted. If those fees are defined as taxes, then, under the US Constitution, the bill must first be passed by the House of Representatives. The House passed a food safety bill in July, 2009, but it is different than the Senate version — meaning that, for the Senate bill that was passed on Tuesday to become law, it must first be voted on by the House, and then again passed by the Senate, before being signed into law by the president.

Beyond the FDA’s Policing Power on Food Safety

Have you ever seen a car running red light or speeding but no police around to catch it?  Have you ever wondered the traffic lights, signals, and signs are good enough to keep cars and pedestrians safe?  The traffic safety enforcement is only as useful as the people who actually obey it.  Likewise, I think the FDA’s new food safety regulatory power will only be effective when all parties, including farmers (produce, meat, egg, milk, etc.), food production and process companies, food inspectors, importers/exporters, and consumers, agree to cooperate to achieve the same goal–food safety to all humans and animals alike.

Food Safety Issues Appearing in the Media

A while ago, one of my co-workers lent me a book called “In Defense of Food: An Eater’s Manifesto” by Michael Pollan.  My eyes were wide-opened by several examples of how our nutrition was compromised by industrialized food process.  In conjunction with recent food safety legislation, I also recommend several media reports about food safety and regulations:

Until next post, keep on reading and writing!!

A Different Kind of Direct Sale: Direct-to-Consumer Genetic Test

What is Direct-to-Consumer Genetic Test?

According to the National Institutes of Health’s (NIH) Genetics Home Reference website, direct-to-consumer (DTC) genetic test involves a direct to consumer marketing and sales tactics that bypass the engagement of the health care professionals such as medical doctors, nurse practitioners, or genetic counselors.  In general, consumers order test kits online or through mail, and send in requested samples back to companies; then the test results are sent directly to consumers with minimal consultation and interpretation from health care professionals.

Personalized Medicine Fuels The Development of The DTC Genetic Tests

When the alliance between the NIH-sponsored laboratories and Celera Genomics jointly announced the completion of sequencing the draft of the human genome in 2000, many have predicted the coming era of “personalized medicine”.  The idea is to develop and prescribe a treatment plan or drug based on the information encoding in each individual’s genome.  As a result, personalized medicine tailors individual’s intrinsic differences to improve diagnostics and treatment of diseases.  With the advancement of faster and less expensive DNA sequencing platforms, getting DNA information is easier than ever.  In a sense, the growing numbers of the DTC genetic test products are likely inspired by personalized medicine, a Holy Grail of future medicine.

Who Jumps on The Bandwagon of The DTC Genetic Test

It is a fast-growing market place for at home DTC genetic test that comes with garden varieties of selection. Tests include risk evaluation of diseases like Parkinson, Alzheimer’s, asthma, breast cancer, diabetes, gluten sensitivity, ancestry tracing, drug responsivity, and whole genome scan, etc.  So far, there are 20 companies receiving the FDA’s letters concerning their genetic test kits as medical “devices” that require data-driven regulatory review and postmarket monitor.

Can FDA Come Out a Win-Win Regulatory Policy?

Currently there are already many do-it-yourself at home tests on the markets, such as blood-sugar meter, home pregnancy test, or home colon-cancer-screening test kit, just to name a few.  So what is it so concerned about DTC genetic test?  It is crucial to understand that in all scientific measurements, there are intrinsic errors in sample selection/representation, technology platforms, or statistics inference.  One has to understand the perils of being misled or misinterpreted by the genetic test results, due to test errors (false positive or false negative), excessive claims (based on unproven study), or unrealistic risks/benefits.  It is time for the FDA to come out a clear regulatory policy to protect consumers from getting incorrect information and potential losing privacy, and at the same time to validate safety and effectiveness of company’s test device/kit as well as to monitor proper disclosure of risks and benefits of test results.

Until next post, keep on reading and writing!!