Federal Court Brings Charges against Producer of Dietary Supplements

A socialite who called herself the “Diet Queen to the Stars” was fined $60,000 on June 20, 2014 by a United States magistrate judge for misbranding a weight-loss supplement that was previously linked to suspensions of several National Football League players in 2008. Nikki Haskell and her now-obsolete company, Balanced Health Products, Inc., were sentenced by a federal judge in Manhattan, New York after issuing a guilty plea to a misdemeanor charge involving the sale of a drug called StarCaps.

Prosecutors had initially pursued a $100,000 fine. Under a plea agreement announced in March 2014, Haskell, 73, also faced up to six months in prison. Haskell told the judge that she was “so remorseful for this” and that it was “never [her] intent to do anything inappropriate [her] entire life.”

Haskell, a onetime television show host, has occasionally appeared in the gossip column in the New York Post and had previously billed herself as the “Diet Queen to the Stars.” She was the chief executive of Balanced Health, the company that marketed the garlic-and papaya-containing StarCaps as an “all-natural diet supplement.”

However, in 2008, Balanced Health issued a voluntary recall of the product, citing the presence of bumetanide, which is used to treat high blood pressure, swelling, renal failure, and heart failure. It was also recalled because it carries serious health risks including electrolyte and fluid loss. Bumetanide is banned by the NFL and several other sports organizations as a potential steroid-masking agent.

During the hearing, Haskell claimed that she was unaware that StarCaps contained bumetanide, adding that she had never heard of the product until she received word of football players using it. In 2008, the NFL cited the product when it announced four-game suspensions to six players on the Minnesota Vikings, Houston Texans, and New Orleans Saints who tested positive for several banned substances.

That same year, two other players, Grady Jackson of the Saints and Jamar Nesbit of the Atlanta Falcons, filed a lawsuit against Haskell and her company after the players tested positive for bumetanide and were consequently suspended from four games. In 2010, Haskell filed for Chapter 7 bankruptcy, listing potential multimillion-dollar lawsuits filed by the NFL, its players, and teams including the Texans, Falcons, Vikings, and Saints.

Ahead of the June 2014 hearing, Nesbit sent a letter to United States Magistrate Judge Netburn requesting that part of Haskell’s sentence include what Haskell’s lawyer, Chris Manicini, described as a “shocking” amount of money. A lawyer for Nesbit was not immediately available for comment.

According to Assistant U.S. Attorney Robin Morey, the NFL had known since 2006 that the product in question contained bumetanide, but the organization allegedly failed to tell anyone. She said that this apparent lack of legal obligation to inform the U.S. Food and Drug Administration was “unfortunate,” although the agency had apparently found no evidence of injuries or deaths of anyone taking StarCaps.

Philip Walsky, acting director of the FDA’s Office of Criminal Investigations, reported that there is a strict regulatory process in the United States for the dispensing and distribution of prescription drugs. According to Walsky, dietary supplements cannot legally contain these drugs. He maintains that the FDA will continue its vigilance in investigating the dietary supplement market.

Sources:
http://www.medicalnewstoday.com/releases/278745.php

Tattoo Ink and Needles Recalled

As tattoos become increasingly common in the United States, their safety demands thorough attention and review. In addition to an illness as is suspected in one case involving California-based White & Blue Lion, Inc., tattoos performed with defective or dangerous needles or inks can potentially lead to scarring, infection, allergies, MRI complications, and granulomas. While there is always a risk of contracting a disease or suffering from side effects while undergoing a tattoo procedure at either a home or licensed tattoo business, experiencing complications following a “tattoo party” at an individual’s residence is often more common.

The U.S. Food and Drug Administration announced on July 14, 2014 that multiple lots of tattoo needles and inks sold by a company over the Internet have been pulled from the market due to potential bacterial contamination. White & Blue Lion issued the voluntary recall for all of the company’s tattoo kits, inks, and needles. The products are sold separately by White & Blue Lion and 8Decades through Amazon.com.

FDA officials warned that the recalled inks and needles may cause a bacterial infection that can ultimately lead to sepsis, a life-threatening complication of an infection. Laboratory testing conducted by the FDA determined that microbial bacterial contamination was present in both the needles and the inks, according to agency officials. This data suggests that Mycobacterium can be ruled out as one of the contaminants. There has been at least one confirmed illness connected with the products as of July 11, 2014.

In Dayton, Ohio at Cloak and Dagger Tattoo Studio, tattoo artist Jeremy McGrady said that White & Blue Lion is not a major supplier of tattoo needles and ink to the industry. McGrady also stated that he had never heard of the company, acknowledging that he is familiar with most of the larger manufacturers. McGrady suspects that the only people who would be impacted by the voluntary recall are those who are making the decision to perform or receive tattoos from homes rather than licensed tattoo parlors.

Similarly, River City Tattoo Company in Iowa was questioned about the recall and stated that it does not use tools or products manufactured by White & Blue Lion, asserting that the needles and inks in the shop are always highly certified. According to Keegan Rocha, the shop manager, the business takes pride in its work and considers itself professional.

The products involved in the July 2014 recall by White & Blue Lion include a multi-colored Chinese Dragon Image tattoo kit with black and white lettering with Lot No. OR20036, Batch #8, in a 5-milliliter bottle. The tattoo needles affected by the recall are sold in packages of five and they bear the label “CE0197 Pre-made tattoo needle.”

As an added precaution, the company is also pulling its ink cups and tubes from the market. The full recall is being made with FDA knowledge. Consumers are urged to contact White & Blue Lion for more information, according to FDA officials.

Sources:
http://www.fda.gov/Safety/Recalls/ucm404787.htm
http://www.daytondailynews.com/news/news/breaking-news/contaminated-tattoo-ink-needles-recalled/ngfTD/
http://www.consumeraffairs.com/recalls/white-blue-lion-updates-recall-of-tattoo-ink-needles-and-kits-071714.html
http://kimt.com/2014/07/16/tattoo-ink-recall/

Safety Warnings for Fish & Crab Toxins from Select California Counties

The California Department of Public Health has issued a health advisory against eating small fish–like anchovies and sardine– because they normally are not cleaned before consumption. Unacceptable levels of domoic acids have been found in similar types of fish, such as muscle shells. Because these small fish are rarely gutted, the CDPH included them in the group that also includes mussels, clams and whole scallops. The previous warning was issued on April 4. The public health agency also stressed that these warnings are limited to the Monterey and Santa Cruz County area.

The CDPH also emphasized that the warnings do not extend to seafood products caught by legal commercial fishing businesses as these fishing operations are subject to regular comprehensive testing of their harvest. The department continues to monitor these specific water regions around Monterey and Santa Cruz County for domoic acid levels among muscle fish, but the certified harvesters are still acceptable sources for the smaller varieties of seafood. Novice recreational fishermen or anglers should not consume anything caught that is untested. The toxic acid forms naturally in phytoplankton and manifests through the shellfish food chain.

According to the Food Safety News, symptoms of domoic acid food poisoning can appear within 30 minutes, but there is no specific timeline. Generally, symptoms should arise within a 24-hour period. Problems may depend on the concentration of the poison and the amount consumed, but the condition can be very serious. The most severe cases can result in death, but intermediate cases usually include abdominal and digestive problems, along with headaches and dizziness.

Anyone who has eaten any seafood that possibly contains concentrated domoic acid levels should seek professional medical attention quickly. The California Department of Public Health encourages everyone to contact them with information that may help reduce the number of illnesses associated with this potentially dangerous situation. Although the professional medical facilities are good at reporting threatening public health problems, individuals also get sick and do not seek treatment. For a variety of reasons, the health agency would like to hear from the public when any case of food poisoning occurs because of the potential impact on overall public health.

References:
http://blog.usfoodsafety.com/2014/04/16/california-expands-warning-about-anchovies-sardines/
http://www.foodsafetynews.com/2014/04/ca-warns-consumers-about-toxins-in-anchovies-and-sardines/
http://www.dfg.ca.gov/marine/

FDA Sued Over Mercury Labeling of Fish

The average American today is better informed about food than at any other time in history, but there is still room for more information. As the government agency responsible for public food safety, the FDA usually bears the brunt of demands for changes in food labeling policy. According to a recent news article, The Center for Science in the Public Interest and the Mercury Policy Project filed a lawsuit against the FDA demanding that more warning labels be applied to fish that may have high mercury content.

Why is Mercury in Fish a Big Deal?

Mercury is a highly toxic metal. It exists in many places, but it is especially a problem for marine life due to human industrial activity. Mercury released into the air eventually enters water sources and then finds its way to the ocean where it becomes locked into the marine food chain. The mercury then concentrates at the top of the food chain, so larger fish and marine predators tend to have the highest levels of mercury in their system.

Most of the warnings sought in the lawsuit target pregnant women and children because there is a much lower tolerance for mercury in children. If a pregnant woman consumes mercury, the metal will contaminate the fetus, and mercury contamination has been linked to many adverse health conditions, especially neurological disorders.

Not All Fish Are Equal

Since mercury concentrates at the top of the food chain, there are a select few types of fish with high concentrations. These include sharks, swordfish, king and Spanish mackerel, most types of tuna, and several others. The location of the fish is also something to consider. Any fish raised in farms, especially in Asia, tend to contain more mercury and other contaminants due to the significantly higher contaminants in the water.

The good news is that most species of fish are safe, and they can be enjoyed regularly. Even the contaminated fish can be eaten safely in small and infrequent amounts, although the species at the top of the list should be avoided completely.

Why a Lawsuit?

Lawsuits are common ways that organizations and individuals can affect policy change. This particular lawsuit does not claim any restitution or damages like injury lawsuits. Instead, it demands a needed change and attempts to push the court to enforce the change. It is often a more efficient way to enact change than lobbying or political process, but it is not always successful. Even if such a lawsuit fails, however, it will still have brought the concern more into the public eye, which can still have a beneficial effect.

The current lawsuit is still undecided. If the lawsuit is successful, then the warning labels will become mandatory and hopefully the public will become even better informed about the risks of certain kinds of fish. It will also help focus the concern. Consumers do not need to be wary of all fish, but they do need to be wary of certain species.

Sources:
http://www.businessweek.com/articles/2014-03-12/consumers-need-mercury-labels-on-seafood-claims-lawsuit-against-fda
http://www.nrdc.org/health/effects/mercury/guide.asp
http://www.scientificamerican.com/article/how-does-mercury-get-into/
http://www.ens-newswire.com/ens/oct2006/2006-10-17-02.asp

Poison Control Centers Receive Increased Number of E-Cigarette Related Calls

As of late, e-cigarettes have been widely regarded as the safer and less offensive alternatives to traditional tobacco cigarettes.,That doesn’t mean they haven’t posed other risks. Recently, there has been an abnormal rise in calls to US poison control centers  regarding electronic cigarettes. The number of calls regarding these devices has increased by a whopping 161%, and local firefighting professionals in the area of Phoenix, Arizona have reported a significant problem with electronic cigarettes starting fires.

Smoking electronic cigarettes, also known as “vaping,” is an alternative many people are using to get away from the cancer-causing effects of traditional tobacco cigarettes. However, the poison control center for Kosair Children’s Hospital in Louisville, KY had received nearly 40 calls in relation to electronic cigarettes in 2013. This was a vast change from the mere 9 calls received in 2012.

What’s surprising is that researchers have found nearly 30% of electronic cigarettes contain equal levels of acrolein and formaldehyde as there are in regular cigarettes. Another growing problem is that nearly half of the calls received by Kosair’s Children’s Hospital concerned children. This was due to mishaps such as children gaining access to the electronic cigarettes while their parents were away or when the devices were charging.

Electronic cigarettes are also a growing concern for fire hazards. One of the primary problems with electronic cigarettes is that cartridges are overheating while the device is charging, causing the onset of a fire. What’s worse is that the devices are being left for hours on end in dangerous places, such as flammable surfaces or other pieces of furniture.

Thus far, neither the American Cancer Society nor the Food and Drug Administration have  reported on the safety of electronic cigarettes.
The FDA is currently attempting to regulate e-cigarettes to mitigate their dangers, but at this time, nothing has been set in stone. The only law that currently exists for electronic cigarettes mandates that manufacturers cannot advertise the devices as a means of quitting smoking, as there has been no evidence to support this type of claim.

Source:

http://www.knoxnews.com/news/2014/jan/02/vaping-latest-phenomenon-hit-cigarette-industry-sp/