Common Law - The FindLaw Consumer Protection Law Blog

November 2013 Archives

23andMe DNA Kit Blocked by FDA as 'Medical Device'

The FDA has ordered DNA testing company 23andMe to stop selling its home DNA testing kits, alleging that the company made baseless claims about diagnosing disease.

23andMe's popular DNA testing kit, previously available through its website for as low as $99, is advertised as providing information about an individual's "genetic health risks."

But the U.S. Food and Drug Administration (FDA) claims the kits are "being sold illegally to diagnose diseases" and have not been given proper FDA approval for a medical device, reports NBC News.

FDA Regulation of Medical Devices

Home testing kits, even ones which can be bought over-the-counter and do not require a doctor's prescription, are regulated by the FDA as "medical devices."

Like the FDA-approved HIV rapid home-use testing kit, most home testing kits are devices which are intended for the diagnosis of disease or conditions, like HIV or pregnancy.

23andMe is a DNA testing kit which works by analyzing the DNA contained in saliva which users submit to 23andMe's labs. The 23andMe user is then notified when the DNA data has been fully processed, and he or she can then view "health reports" based on his or her DNA profile.

With the FDA even cracking down on smartphone health apps, 23andMe's service wasn't likely to escape regulation for long.

Demand to Stop Sales

In a strongly worded letter to 23andMe's CEO Ann Wojcicki, the FDA reminded the company that advertising the DNA kit's intended use as a "first step in prevention" of diseases like diabetes and cancer puts them well within the medical device classification.

And although 23andMe had already applied for clearance in 2012, the FDA was not convinced that it had approved any prior product or device which was intended for the same use as the 23andMe kit. Without such clearance, the FDA can stop the product from being sold or marketed.

The first step in being cleared to sell a medical device is to prove that a similar product has already been cleared by the FDA to be sold -- called a predicate device. The FDA claims that 23andMe has yet to provide evidence that its kit, which is advertised as screening for variants of the BRCA breast cancer gene marker, is like any other FDA-approved device on the market.

There are other gene testing companies out there, but 23andMe is the first being told to "stop marketing its test," reports NBC news.

Related Resources:

Don’t Let the Holidays Ruin Your Credit Score: 5 Tips

The holidays are upon us, and they may affect your credit scores.

One's credit score could take a hit during the holidays in a number of ways. You may see a less than festive dip from overcharging and not paying your credit card bills in a timely manner or by being the victim of credit fraud.

Your credit score can follow you almost like a criminal record, and it can make big, important purchases -- like houses or cars -- much more difficult than they should be. In order to keep your holidays merry, here are five tips to protect your credit score this holiday season:

  1. Check it. Many Americans haven't even checked their credit scores, which is alarming at any time of the year. Knowing your credit score can help you gauge many of your spending habits. Make sure you know what your score is before you dive into the season of spending.
  2. Pay off all your bills. One of the crucial factors affecting your credit score is how timely your payments are and if you make them. Make sure that your prior bills are all paid off before you rack up even more this holiday season.
  3. Think twice before signing up for a new card. It may be tempting, especially with all the instant savings that retailers will offer you, but consider all your other options. Signing up for a new credit card not only means a slight dip in your credit score, but do you really need a new line of credit to worry about paying off in the new year?
  4. Keep up the good habits. While you may have plans to leave town or be more social during the holidays, make sure that your priorities are still in check. You should still try to save when you can, pay your bills on time, and, if you have them, don't forget about those student loans, either.
  5. Sign up for credit card fraud alerts. Make sure you sign up for credit card fraud alerts. This not only can help you detect credit card fraud right away, but you could also prevent identity theft. You should still protect yourself the best you can from those looking to prey on the increased number of shoppers in stores. But, sometimes theft happens, and you can at least remedy a fraud situation quicker by having these alerts.

Last but not least, happy holidays! Just remember to be careful.

Related Resources:

Though it may seem like many employers are requiring social media passwords as a condition of employment, in reality, that doesn't appear to be the case.

In fact, only 3 percent of Americans have been asked by an employer to fork over their social media passwords, a new FindLaw survey reveals.

Happy News for Employees

The rarity of password collection by employers is welcome news to employees. In fact, 83 percent of American adults say that employers should not be allowed to obtain passwords to personal social media accounts, such as Facebook, Twitter, and YouTube, according to the FindLaw survey.

Only a mere 7 percent of surveyed individuals said employers should have the right to access their social network passwords. Another 10 percent weren't sure how they felt about the practice.

One natural question to ask is why aren't employers asking for passwords? After all, password collection could purportedly help companies screen job candidates, protect proprietary information or trade secrets, comply with federal financial regulations, thwart PR disasters, and protect against vicarious legal liability.

The low rate of password collection may be due to employers' fear of legal liability for invasion of employee privacy. Particular concerns include accessing an employee's social media accounts and unwittingly discovering an employee's protected characteristics, such as religious preferences, confidential medical information, and arrests that never resulted in convictions.

As for the potential for lawsuits, just last year, Facebook announced that it may initiate legal action against employers who ask for job seekers' Facebook passwords. Apart from incurring the wrath of Facebook, employers have emerging state laws to fear too.

Laws Prohibiting Password Collection

At least 10 states have passed laws that expressly prohibit employers from requesting passwords to personal online accounts as a condition of employment, according to the National Conference of State Legislatures. Similar legislation is pending in at least 26 other states.

A handful of states have also passed legislation to prevent public colleges and universities from obtaining access to students' social networking accounts, according to FindLaw.com.

If you're an employee or employer who would "Like" more information on the legality of password collection policies, you may want to consult an experienced employment attorney near you.

Related Resources:

OxyElite Pro Recalled Over Hepatitis Fears

An OxyElite Pro recall is underway after the supplement was linked to an outbreak of liver illnesses, including one death. The Food and Drug Administration (FDA) made this announcement Sunday, USA Today reports.

OxyElite Pro products are typically used as weight-loss supplements. Capsule and powder versions of the product are affected by the recall.

The OxyElite Recall

This OxyElite Pro recall comes on the heels of an investigation that linked cases of liver failure and hepatitis to the product. The FDA sent a letter last week to Dallas-based USPlabs LLC that if it didn't voluntarily recall the supplements, the agency would be forced to order the company to stop distribution.

While dietary supplements don't actually need FDA approval before being hitting the retail market, this doesn't mean that they aren't just as susceptible to being recalled -- especially after serious cases of liver illness and even a death.

For a full list of the affected products, check out the FDA's press release here.

If You've Been Affected

If you think that you've purchased any affected batches of OxyElite Pro, you may have legal recourse. For example, defective supplements can potentially fall under the category of product liability claims. Generally, if a consumer wants to sue for a product-related injury, the harm has to be linked to the manufacturer's product or defect.

You'll want to consult with an experienced products liability attorney to help you figure out the best way to proceed. A lawyer would likely advise you to:

  • See a doctor immediately;
  • Save evidence, such as bottles of the pills you took and your receipts; and
  • Keep track of your medical expenses so that you can potentially get reimbursed for those.

Consumers can also call USPlabs toll-free at (800) 890-3067.

Related Resources:

Ready-to-Eat Salads, Sandwiches Recalled Over E. Coli Fears

A California catering company has recalled more than 180,000 pounds of ready-to-eat salads and sandwich wraps with chicken and ham that may be contaminated. Glass Onion Catering company products that were shipped to distribution centers all over the country may contain strands of E. coli, the Associated Press reports.

The recall lists Trader Joe's, Whole Foods, and Walgreens as companies that may have carried the affected items.

How do you know if you've been affected, and what should you do if you suspect you're ill?

Products Affected

At least 26 people in three states have contracted E. coli related to these products. Of those affected, 15 persons have reported consuming products in the recall. The affected products were produced between September 23 and November 6 and shipped to distribution centers in California, Nevada, Arizona, New Mexico, Oregon, Utah, Washington, and Texas.

The products subject to recall bear the establishment number "P-34221" inside the USDA mark of inspection. This includes Atherstone Fine Foods style wraps and certain Trader Joe's ready-made salads. For a full list of affected products involved in the recall, check the USDA website.

Consumers Affected

If you've purchased any of the above-listed products, what can you do? Consumers who may have these products in their fridges are urged to discard them or return them to the place of purchase for a full refund.

E. coli can lead to diarrhea and even kidney failure in some cases. If you believed that you've consumed an affected product, you may have a potential food poisoning claim on your hands. Food poisoning generally applies under a product liability theory, in which the consumer would need to prove that the manufacturer or seller is liable for the defective product (in this case, the salads and sandwich wraps).

There are a number of product liability theories that may apply to you if you've been affected. If you fear you've come into contact with any of these products, consider contacting a qualified attorney who can discuss these with you and how to protect your rights and seek proper compensation.

Consumers with questions regarding the recall can also use the online Electronic Consumer Complaint Monitoring System.

Related Resources:

FDA to Ban Trans Fats, but Not Sure When

The Food and Drug Administration is making a big move to phase out trans fats from Americans' diets. The days of your favorite artery-clogging ingredient, partially hydrogenated oils, may soon be numbered.

If you have an opinion on the impending death of partially hydrogenated oils, you may want to "weigh in" on the FDA's comment period.

Partially Hydrogenated Oils (PHOs)

The FDA announced that partially hydrogenated oils (PHOs), the primary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in foods. Trans fats are considered harmful because they increase risks for heart disease by both raising bad cholesterol levels (LDL) and lowering good cholesterol (HDL), according to the FDA's press release.

While some states and cities such as New York and California have barred trans fat from restaurants, food producers are still free to include it in their products. One of the major reasons food producers use PHOs is to keep costs down. It's a less expensive fat than available alternatives.

The FDA's PHOs ban could potentially prevent 20,000 heart attacks a year and 7,000 deaths, according to the release.

How to Make a Comment

Under the FDA Food Safety Modernization Act (FSMA), which President Obama signed into law in 2011, the FDA is accepting public comment on the draft regulation for 60 days before it becomes binding.

The FDA issues a proposed rule, which is published in the Federal Register (FR) as well as the FDA's official docket, so that members of the public can review it and send their comments to the agency.

The agency hopes to collect additional data and to get input on how much time it might take for food manufacturers to reformulate products that currently contain artificial trans fats.

If the rule becomes binding, PHOs would be considered “food additives” and could not be used in food unless authorized by regulation.

In the meantime, the FDA urges consumers check trans fat levels on the nutrition facts panel on the back of processed food packages and avoid those products with trans fats.

Related Resources:

Special software meant to help concerned parents monitor their child's Internet activity is being offered for free by the Cook County State's Attorney's Office. "ComputerCop" allows parents to review their child's Internet actions and find out if their children are being exposed to any harmful or inappropriate material, Chicago's WBBM-TV reports.

“As the number of children who use technology continues to soar, the need for education and the commitment to the protection of children who are exposed to online predators must also increase,” said State Attorney Anita Alvarez.

What does ComputerCop do, exactly, and how can you ensure your child's online safety?

ComputerCop's Many Features

ComputerCop was developed by several law enforcement agencies, including the F.B.I., and Cook County is not the only area offering the software. Several other counties, including Solano County in California, are offering it as well, with some places charging a small fee.

A key feature of the ComputerCop software is a database of around 2,000 "red-flagged" words that are associated with pornography, violence, and drugs. The program also:

  • Contains a "delete" function for parents to remove inappropriate material;
  • Displays all images stored on the computer;
  • Scans for content based on the above-mentioned red flag words; and
  • Provides a search option for all files, or just most recent files.

Protect Your Children

Besides the ComputerCop software, what are some other ways that parents can protect their children when it comes to online activity? Here are a few options:

  • Moving your child's computer to a common area of the house for easier monitoring;
  • Discussing Internet usage with your child. Parents can limit this to certain hours or purposes (for school research only, for example);
  • Warning your child about interacting with strangers or giving out any personal information to non-trusted sources;
  • Keeping track of your child's activity on social media -- checking the privacy settings and ensuring that they aren't too public.

For more information about online safety for children, check out FindLaw's Online Safety For Kids.

Related Resources: