Tuesday, September 16, 2014

Regeneca Expands Recall of RegeneSlim Dietary Supplement

Regeneca Worldwide is expanding its voluntarily nationwide recall of RenegeSlim appetite control dietary supplement because FDA analysis confirmed the presence of DMAA. DMAA is 1,3-dimethylamylamind, methylhexanamine, or geranium extract. It can narrow blood vessels and arteries, which can cause a rise in blood pressure that increases the risk of heart attack.



http://www.fda.gov/Safety/Recalls/ucm408674.htm

FDA takes action against Georgia dietary supplement manufacturer

A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. 
BioAnue’s products were sold as supplements but were unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes, without approval from the FDA, according to the court order. The order was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia.   
The defendants did not take appropriate corrective action in response to a FDA warning letter issued on Feb. 9, 2012, involving the marketing of the firm’s dietary supplements as unapproved new drugs. A follow-up FDA inspection in August 2012 revealed that BioAnue was also manufacturing products that were not in compliance with FDA’s current good manufacturing practice requirements for dietary supplements.
The permanent injunction prohibits the manufacture or distribution of products until the defendants hire independent experts to assist in bringing the firm’s manufacturing practices and labeling into compliance with the law.
District Judge Marc T. Treadwell said, in the court order, that the government was able to provide evidence that the defendants sold unapproved new drugs and failed to follow FDA’s current good manufacturing practice regulations for dietary supplements.
“The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”
The defendants’ products include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA warns of dangerous drugs in weight loss supplements: Tainted dietary supplements

The Food and Drug Administration is warning consumers that three weight loss supplements sold online and in some retail stores contain dangerous pharmaceutical ingredients hidden from consumers, and should be thrown away.

The supplements-- called LX1, Mezo, and Best Line Suplemento Alimenticio-- are part of a growing trend of dietary supplements sold for weight loss and sexual enhancement, usually advertised as "herbal" or "all natural," which really contain pharmaceutical ingredients.

According to FDA testing, LX1 contains undeclared DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract. DMAA, an amphetamine derivative, is an illegal ingredient often sold in products that claim to boost energy, burn fat or build muscle. It can "can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack,"according to the FDA.


The Food and Drug Administration (FDA) is advising consumers not to purchase or use LX1, a product promoted and sold for weight loss on various websites, including Dr. Skin Secretsdisclaimer icon, and possibly in some retail stores.LX1 Contains Hidden Drug Ingredient
FDA laboratory analysis confirmed that LX1 contains undeclared DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract. Ingestion of DMAA can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.
Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories. 

Friday, August 29, 2014

FDA warns consumers: Dietary supplements cannot treat concussions

Yadier Molina suffered a mild concussion on Ju...
Yadier Molina suffered a mild concussion on June 15, 2008 (Photo credit: Wikipedia)
The U.S. Food and Drug Administration is warning consumers about dietary supplements that falsely claim to prevent or cure concussions or other traumatic brain injuries. The FDA says supplements with labels that make these claims are not backed up by scientific evidence, and in a consumer alert issued Monday it urged users to beware.
It’s back-to-school time, and kids are already starting practice for football, soccer and other sports. It’s a time when parents may be thinking about sport safety and the potential for their kids to be injured by violent jarring and shocks.
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.

False Claims

One of the first alarms that dietary supplements are promoted to treat TBI was raised by the U.S. Department of Defense.
"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, which is a hot-button issue," says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That triggered our surveillance."
FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.
Typically, dietary supplements promising relief from TBIs tout the benefits of ingredients such as turmeric (an Indian spice in the ginger family) and high levels of omega-3 fatty acids derived from fish oil. In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have "the world's first supplement formulated specifically to assist concussion recovery," saying "it has the dynamic ability to minimize long-term effects and decrease recovery time." A National Football League player testified to its "proven results in my own recovery" from a concussion, and an unnamed "licensed trainer" said he had incorporated it into his "concussion management protocol."
Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, they could result in legal action taken without further notice, such as seizure or injunction.
Both companies changed their websites and labeling.
In December 2013, FDA issued a warning letter to another company for marketing its product with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.
"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them," says Coody. "If someone tells you otherwise, walk away."

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378845.htm#claims

FDA warns parents about getting their kids contact lenses

Lens cover for storing contact lens
Lens cover for storing contact lens (Photo credit: Wikipedia)
Dr. Elias Traboulsi, a pediatric ophthalmologist at Cleveland Clinic, says the FDA wants parents to know that age is not the only factor to consider getting contacts for your child
The discussion should not be "  my child wants contact lenses and they are responsible equals he gets them. There should be more thought into it and more caution about it," explained Traboulsi.
FDA researchers cite a 2010 study in the journal Pediatrics. It looked at the number of children taken to the emergency room each year for complications related to medical devices.
It found about 25% of the injuries were related to contact lenses. The most typical problems are infections and eye abrasions, which are often caused by a lack of hygiene.  That's why the FDA is warning parents who are considering contacts for their children to gauge their child's maturity level and whether they can handle the daily responsibilities. 

http://www.news4jax.com/news/fda-warns-parents-about-getting-their-kids-contact-lenses/27775824


Should You Consider This? Why I think it's a Mistake to consider OCP for acne treatment

Just out is a report on JAAD titled:

Meta-analysis comparing efficacy of antibiotics versus oral contraceptives in acne vulgaris


Here's the abstract, with my concerns below it:
http://www.eblue.org/article/S0190-9622(14)01291-2/abstract>

Background

Both antibiotics and oral contraceptive pills (OCPs) have been found to be effective in managing acne vulgaris. Despite widespread use, few direct comparisons of efficacy between the 2 modalities have been published.

Objective

We compared the efficacy of antibiotics and OCPs in managing acne.

Methods

A meta-analysis was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane collaboration guidelines.

Results

A review of 226 publications yielded 32 randomized controlled trials that met our inclusion criteria. At 3 and 6 months, compared with placebo, both antibiotics and OCPs effected greater percent reduction in inflammatory, noninflammatory, and total lesions; the 2 modalities at each time point demonstrated statistical parity, except that antibiotics were superior to OCPs in percent reduction of total lesions at 3 months (weighted mean inflammatory lesion reduction: 3-month course of oral antibiotic treatment = 53.2%, 3-month course of OCPs = 35.6%, 3-month course of placebo treatment = 26.4%, 6-month course of oral antibiotic treatment = 57.9%, 6-month course of OCPs = 61.9%, 6-month course of placebo treatment = 34.2%; weighted mean noninflammatory lesion reduction: 3-month course of oral antibiotic treatment = 41.9%, 3-month course of OCPs = 32.6%, 3-month course of placebo treatment = 17.1%, 6-month course of oral antibiotic treatment = 56.4%, 6-month course of OCPs = 49.1%, 6-month course of placebo treatment = 23.4%; weighted mean total lesion reduction: 3-month course of oral antibiotic treatment = 48.0%, 3-month course of OCPs = 37.3%, 3-month course of placebo treatment = 24.5%, 6-month course of oral antibiotic treatment = 52.8%, 6-month course of OCPs = 55.0%, 6-month course of placebo treatment = 28.6%).

Limitations

Investigative treatment heterogeneity and publication bias are limitations.

Conclusions

Although antibiotics may be superior at 3 months, OCPs are equivalent to antibiotics at 6 months in reducing acne lesions and, thus, may be a better first-line alternative to systemic antibiotics for long-term acne management in women.

My concerns: In the Yaz litigation, Plaintiffs in claims over Yaz and Yasmin include allegations that the drugs were marketed and advertised in a way that exaggerated benefits such as acne reduction and downplayed serious dangers associated with the drug. Unfortunately, a client of ours who was prescribed the product to help with acne ended up (she alleges) with blood clots and DVT's that were so severe she had to endure multiple surgeries. I know and appreciate that this is just one instance of what she claimed was a horrible result, take the time to read what OCP's side effects are.    


Tuesday, August 26, 2014

Benicar and the FDA: FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil

The U.S. Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.  FDA has approved changes to the labels of these drugs to include this concern.
Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization (see Data Summary). If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started. Discontinuation of olmesartan has resulted in clinical improvement of sprue-like enteropathy symptoms in all patients.
Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs.  Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan.

The FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.

Multiple Class-Action Suits Filed Against Vitamin Maker

From the NYT:


At least 9 class-action lawsuits were filed in Federal District Court in Islip in the last week against NBTY, the vitamin and supplement company in Bohemia, after the company announced last month that sales had fallen at some of its operations.
The suits accuse Scott Rudolph, the chairman of the company, and Harvey Kamil, its president, of defrauding investors by using a promotional mailing to increase sales beyond analysts' expectations and then predicting, erroneously, continuing revenue growth.

http://www.nytimes.com/2004/07/04/nyregion/in-brief-multiple-class-action-suits-filed-against-vitamin-maker.html

Proposed FL Bar Rule regarding Lien and Subrogation Issues

Here's the proposed Rule addition to  Rule 4-1.5(f). Also find it online, here: http://www.floridabar.org/DIVCOM/JN/jnnews01.nsf/8c9f13012b96736985256aa900624829/13895febd04ae96d85257d260049ffb1!OpenDocument

This is a proposed key change in how liens are handled in FL. As a matter of practice, my office does not charge for this service. In certain cases, depending on complexity of course, a 3rd party may be needed. Stay tuned  to see if the rule is adopted:    

(f) Contingent Fees. As to contingent fees:
    (1) [no change]
    (2) [no change]
    (3) [no change]
    (4) A lawyer who enters into an arrangement for, charges, or collects any fee in an action or claim for personal injury or for property damages or for death or loss of services resulting from personal injuries based upon tortious conduct of another, including products liability claims, whereby the compensation is to be dependent or contingent in whole or in part upon the successful prosecution or settlement thereof shall do so only under the following requirements:
  • comments: 
when reasonable efforts to negotiate such medical liens or subrogation claims fail, the lawyer may, with the client’s written informed consent, either refer the client to a third party or hire a third party on behalf of the client to handle the lien and subrogation resolution who may charge a separate fee or cost to the client. If a lawyer provides the extraordinary lien and subrogation services, that lawyer’s contract with the client must separately comply with all provisions of rule 4-1.5. 

Monday, August 25, 2014

Nestlé Prepared Foods Company Announces Allergy Alert and Voluntary Recall Of LEAN CUISINE® Culinary Collection Chicken with Peanut Sauce Recall Due to Package Mislabeling

Nestlé Prepared Foods Company, a business unit of Nestlé USA, is initiating the voluntary recall of a limited quantity of LEAN CUISINE® Culinary Collection Chicken with Peanut Sauce/UPC code 13800 10154 because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products.
The affected product is marked with a production code of 4165595911U and has a “best before” date of JULY 2015. A small quantity of LEAN CUISINE Culinary Collection Shrimp Alfredo was inadvertently placed into packaging for LEAN CUISINE Culinary Collection Chicken with Peanut Sauce.
Three consumers who purchased the mislabeled product alerted Nestlé to this issue. To date, no illnesses or allergic reactions have been reported. Nestlé issued this voluntary recall of one hour code of production to ensure the safety of consumers with shellfish allergies.
Consumers who may have purchased LEAN CUISINE Culinary Collection Chicken with Peanut Sauce /UPC code 13800 10154should look for the manufacturing code, located in the grey box, on the right side panel of the package. The manufacturing code of the recalled product is: 4165595911U. No other LEAN CUISINE items are impacted by this recall. The affected product was distributed to retail customers in Washington State, California, Louisiana and Texas, and can be found in the frozen food aisle. Nestlé asks consumers to contact us for a full refund by calling Nestlé Consumer Services directly at 1-800-392-4057 Monday through Friday from 8:00 AM to 8:00 PM EST.
The quality and safety of our products are the top priority for our company. For these reasons, the company initiated this recall. We apologize to our retail customers and consumers and sincerely regret any inconvenience created by this product recall. We have advised the U. S. Food & Drug Administration and the U.S. Department of Agriculture of this voluntary recall and will cooperate with them fully.

FDA takes action against Georgia dietary supplement manufacturer

A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. 
BioAnue’s products were sold as supplements but were unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes, without approval from the FDA, according to the court order. The order was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia.   
The defendants did not take appropriate corrective action in response to a FDAwarning letter issued on Feb. 9, 2012, involving the marketing of the firm’s dietary supplements as unapproved new drugs. A follow-up FDA inspection in August 2012 revealed that BioAnue was also manufacturing products that were not in compliance with FDA’s current good manufacturing practice requirements for dietary supplements.
The permanent injunction prohibits the manufacture or distribution of products until the defendants hire independent experts to assist in bringing the firm’s manufacturing practices and labeling into compliance with the law.
District Judge Marc T. Treadwell said, in the court order, that the government was able to provide evidence that the defendants sold unapproved new drugs and failed to follow FDA’s current good manufacturing practice regulations for dietary supplements.
“The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”
The defendants’ products include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Tuesday, August 19, 2014

District Court Enters Permanent Injunction Against New York Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements

The Justice Department announced today that the U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction against Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, all of Lindenhurst, New York, to prevent the distribution of adulterated dietary supplements. 

According to a complaint filed July 21, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing dietary supplements that were adulterated.  Under the FDCA, dietary supplement manufacturers are required to have systems in place to ensure that their products meet specifications for identity, purity, strength and composition.  The government’s actions resulted from a series of inspections of APS’ manufacturing facility beginning in 2012, which revealed, among other things, that APS failed to perform identity tests or examinations for certain dietary ingredients before using them in their products. 

In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA.  The consent decree requires the dietary supplement manufacturer to cease all operations and requires that if they wish to resume manufacturing dietary supplements in the future, the FDA first must determine that APS’ manufacturing practices have come into compliance with the law.  The consent decree also requires a recall of all products sold since Jan. 1, 2014.   The consent decree was filed with the complaint and was docketed on July 23.








http://www.justice.gov/opa/pr/2014/July/14-civ-776.html

Social Media Discovery

Facebook logo Español: Logotipo de Facebook Fr...
Facebook logo Español: Logotipo de Facebook Français : Logo de Facebook Tiếng Việt: Logo Facebook (Photo credit: Wikipedia)
I get a chance to speak at CLE's across the country on social media discovery. I am amazed by number of lawyers who just have no idea about what is happening when it comes to developing caselaw on this important subject. 

Before searching the internet far and wide, make sure that you have in your briefcase the go to case of  Trail v. Lesko:



The case involved a car wreck that injured one driver.  The parties both asked to have the other side produce Facebook posts and pictures.  Predictably, the parties fought the request, nobody produced anything, and both parties filed motions seeking to compel their opponent to turn over his Facebook password and username.

 The defendant sought access to the plaintiff's Facebook account, claiming that the account "may" contain evidence of the "extent and severity" of the plaintiff's injuries. The defendant supported his motion with pictures of the injured plaintiff "socializing" at a bar and "drinking at a party," which the defendant had obtained from the publicly available portions of the plaintiff's Facebook account.
Judge Wettick waded into the world of Facebook in the opinion.
He first wrote about Facebook and how it works:  "The sheer volume of potentially relevant information is staggering.In the aggregate, users collectively update their “statuses”(a short indication of what’s on a user’s mind at a given moment, posted to the their own profile page) more than 60 million times each day. Individual users create on average 90 pieces of content every month (photos, status updates, comments or other posts) with fully half of all Facebook users accessing their individual profiles on a given day. Facebook users collectively upload 300 million photos to the site each day"
 He wrote that before a requesting party is  granted "access" to a Facebook account, the party must show a "sufficient likelihood" that the non-public postings would contain information that is relevant to the litigation that is "not otherwise available."  Otherwise, the court held, Rule 4011(b), which protects against discovery that is unreasonably annoying or embarrassing, prohibits unfettered access to a social-networking site.
The Judge went on to note - correctly in my opinion - "a court order which gives an opposing party access to Facebook postings that were intended to be available only to persons designated as “Friends” is intrusive because the opposing party is likely to gain access to a great deal of information that  has nothing to do with the litigation and may cause embarrassment if viewed by others."
Read the opinion first. There are useful nuggets in it, and like most cases dealing with discovery, the case is not a one size fits all approach. 

Monday, August 18, 2014

Powdered Caffeine Dangers

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.
The FDA is aware of at least one death of a teenager who used these products.
These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.
Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.
Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages.

All consumers seeking caffeinated products should be aware of the potentially high potency of these powdered pure caffeine products. Parents should recognize that teenagers and young adults may be drawn to these products for their perceived benefits.


The death of an Ohio teen after eating caffeine powder prompted the FDA warning. An autopsy of 18-year-old Logan Stiner of LaGrange, OH, detected more than 70 micrograms of caffeine per milliliter in his blood. It is 23 times higher than the amount found in a typical coffee or soda drink.
http://www.hngn.com/articles/36606/20140721/fda-issues-warning-against-caffeine-powder-ohio-teen-found-dead.htm

Dietary supplement maker at center of ex-Va. Gov. McDonnell trial halts sales of Anatabloc

Rock Creek Pharmaceuticals Inc. said it is voluntarily stopping sales of Anatabloc and another supplement called CigRx while it sorts out issues with the Food and Drug Administration.

Late last year, the federal agency sent a warning letter to the company formerly known as Star Scientific saying that its products contain a new dietary ingredient that requires approval before it can be marketed. The company did not seek such approval.

The agency also said the company's website had improperly promoted Anatabloc as a drug by suggesting it can be used to treat various diseases, including ulcerative colitis, multiple sclerosis and Alzheimer's disease.













Read more: http://www.wjla.com/articles/2014/08/firm-halting-sales-of-dietary-supplement-anatabloc-105979.html#ixzz3AkpOOicz
Follow us: @ABC7News on Twitter | WJLATV on Facebook

Friday, August 01, 2014

FDA warns of generic Viagra hidden in "natural" O.M.G. supplement

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
More and more and more. Another supplement with hidden viagra:

The Food and Drug Administration (FDA) is advising consumers not to purchase or use O.M.G., a product promoted and sold for sexual enhancement on various websites, including www.sears.com  disclaimer icon, and possibly in retail stores.
FDA laboratory analysis confirmed that O.M.G. contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm406236.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA is Monitoring Certain Foods and Beverages Imported from Taiwan that May Contain Plasticizers

News from the FDA

The U.S. Food and Drug Administration (FDA) is notifying the public about the possible presence of a plasticizer called diethylhexyl-phthalate (DEHP) in certain food and beverages imported from Taiwan.
The Taiwan authorities responsible for food safety have informed the FDA of products shipped to the United States which they believe may be contaminated with DEHP. FDA is screening suspect food products from Taiwan for DEHP and for additional plasticizers such as butylbenzylphthalate, di-n-butylphthalate, dioctyl phthalate, and di-isodecyl phthalate. We expect that the number of suspect products may change as we continue to receive updated information from the Taiwan investigation.
Phthalates such as DEHP are primarily used as plasticizers in polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC) polymers to increase their flexibility. The direct addition of DEHP to food is not permitted in the United States under the U.S. Federal Food, Drug and Cosmetic Act.
Individuals are regularly exposed to plasticizers from a variety of environmental sources. Animal testing has indicated the possibility of adverse effects from long term exposures to DEHP. Little or no adverse health effects are expected from short-term exposure to DEHP at the levels reported to date in food products from Taiwan.
FDA has increased surveillance of food products from Taiwan that are offered for entry into the United States. We are working with Taiwan authorities to continue to identify products that are shipped to the United States that may contain DEHP or other plasticizers. Our review continues and, as we receive additional information, we will conduct further follow up investigations and take actions as warranted.
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm260478.htm

FDA Consumer Advice on Powdered Pure Caffeine

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.
The FDA is aware of at least one death of a teenager who used these products.
These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.
Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.
Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages.

Who should know

All consumers seeking caffeinated products should be aware of the potentially high potency of these powdered pure caffeine products. Parents should recognize that teenagers and young adults may be drawn to these products for their perceived benefits.

What to do

  • The FDA advises consumers to avoid powdered pure caffeine.
  • It is nearly impossible to accurately measure powdered pure caffeine with common kitchen measuring tools and you can easily consume a lethal amount.
  • If you believe that you are having an adverse event related to caffeine, stop using it and seek immediate medical care or advice.
  • The FDA wants to know about adverse events associated with powdered pure caffeine and other highly caffeinated products. You or your health care provider can help by reporting these adverse events to FDA in the following ways:
  • By phone at 240-402-2405
  • By email at CAERS@cfsan.fda.gov

NCAA Concussion Litigation, Court Order issued July 30, 2014

Here's the Order entered this past week:

Tuesday, July 08, 2014

Bausch & Lomb Recalls About 850,000 Tubes of Eye Ointment

Deutsch: Logo der Bausch & Lomb Incorporated
Deutsch: Logo der Bausch & Lomb Incorporated (Photo credit: Wikipedia)
Bausch & Lomb unit has recalled about 850,000 tubes of an eye-care ointment because some tubes contained tiny crystal particles that could injure the cornea.
Bausch & Lomb said  it believed the crystal particles formed when the tubes of Muro 128 ointment were exposed to freezing temperatures during shipments last winter.

http://online.wsj.com/articles/bausch-lomb-recalls-about-850-000-tubes-of-eye-ointment-1404418011

Pfizer recalling 221,000 bottles of Pristiq

Here's the link: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1409-2014&w=07022014&lang=eng


For the second time in recent months, Pfizer has recalled hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet. Pfizer says a single 100 mg tablet of Pristiq Extended Release was found in a 50 mg bottle but the drugmaker is taking no chances and is recalling four lots of the the antidepressant drug.


Testosterone Use Doesn't Increase Heart Risk, Study Finds

The findings, which were published July 2 in the Annals of Pharmacotherapy, found that testosterone therapy was not linked with any increased risk for heart attack. In fact, men at greater risk for heart problems who used testosterone actually had a lower rate of heart attacks than similar men who did not receive this treatment, the researchers said.

http://online.wsj.com/articles/testosterone-use-doesnt-increase-heart-risk-study-finds-1404423497

Wednesday, June 25, 2014

USA v. Mira



Defendants have a history of violating the act,” the complaint said. “Several of the dietary supplement cGMP deviations observed during the July 2013 inspection ... are the same as, or similar to, those observed by FDA during inspections of defendants’ facility between March 13-23, 2012, and between March 18-22, 2013.

Here's the FDA action versus Mira. More later.

Producer of tainted dietary supplements sentenced in Federal Court

Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug.
From at least November 2006 through December 2008, BHP’s primary business was the distribution across the United States of this product, called “Nikki Haskell’s StarCaps” (StarCaps).
BHP advertised StarCaps as weight-loss pills containing only all-natural ingredients including, for example, papaya extract. The company failed to list on the product’s label that the pills also contained bumetanide, a powerful diuretic used clinically to treat heart failure, kidney failure, high blood pressure and swelling (edema). Bumetanide is available in the United States only by prescription from a licensed physician.
In March 2014, Haskell was convicted upon a guilty plea to distributing the misbranded StarCaps from BHP’s New York City-based location. Per Haskell, the company is now defunct and has filed for bankruptcy.
Agents from the FDA’s Office of Criminal Investigations, New York Field Office spearheaded this investigation, which led to the permanent removal of this tainted dietary supplement from the market.
“There is a strict regulatory process in the United States for the distribution and dispensing of prescription drugs, and dietary supplements cannot legally contain such drugs,” said Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “Consumers rely on the labels of dietary supplements to inform them about any potential health risks. The FDA will continue its vigilance over the dietary supplement market.”
Use of bumetanide is banned by certain professional sports organizations, including the National Football League, in part because bumetanide can mask the presence in the human body of steroids and other banned doping agents.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

Doctor's Best Red Yeast Rice Recalled

Doctor's Best is a well known vitamin supplement manufacture, so there is big news that the company is recalling more than 7,300 bottles of its "Best Red Yeast Rice" supplement because FDA testing revealed it contains lovastatin, a cholesterol-lowering medication. 

The supplement can be dangerous for people already taking medications to treat their cholesterol or may cause drug interactions.

In rare cases, using the supplements that contain lovastatin could result in serious muscle injury, particularly in people already taking prescription "statins" such as lovastatin, simvastatin (known by brand name Zocor), or atorvastatin (known by brand name Lipitor). The supplements also pose a risk to pregnant women, and patients with pre-existing liver disease, who may be at an increased risk for liver injury following chronic use of statins, according to the release.

The company has not yet received any reports of illness related to use of the supplement. 

Red yeast rice, a traditional Chinese culinary and medicinal product, can contain substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin (known by the brand name Mevacor). Other red yeast rice products contain little or no monacolin K, but the amount of the substance is not disclosed on the supplement's label and consumers have no way of distinguishing between them, according to the National Center for Complementary and Alternative Medicine (NCCAM).

Link here: http://www.cleveland.com/healthfit/index.ssf/2014/06/doctors_best_recalls_red_yeast.html

Are you a Jerk to the Invisible People in Office Buildings?

NYC: Empire State Building
NYC: Empire State Building (Photo credit: wallyg)
I work in a tall building in Atlanta. I also travel a lot and go into and out of of tall buildings. My personality is such that I almost always smile, greet, and say hello to those who make those big buildings run. You know the people - the security person at the door, the folks who clean the bathrooms, the company that cleans offices. Because I speak spanish (but don't "look" it) I almost always surprise a hispanic person cleaning during the day or evening.

A simple hello, or holding the door for one of them, or a smile is just the decent thing to do.

Then you have the self important assholes.

I see these types a lot - are you one of them? This morning I used the service elevator, loaded with workers. A guy in a suit, on the phone, pushed his way in. Became angry when his suit brushed up against a stationary moving cart. He snarled something, all the while on his phone. He exited, and all was quiet. I said "pendejo" after he left, and the folks started laughing and smiling. The folks on that elevator were invisible to the asshole, until he felt annoyed.

It's not very hard to do the simple things for the people around you.To me, how a stranger treats someone like the cleaning people - in that brief snapshot of time - tells me a lot of what that person is usually about.

So I watched all of this unfold on some non descript day. I was in jeans and a golf shirt, not the usual business wear. I saw three people decide that each didn't want to hold the elevator for a worker. I saw folks decide that it was not worth the effort to hold the door open for a person with a cleaning cart. I saw a guy be a total asshole to a diminutive person who was from Uruguay ( I asked her where she was from after he left- her name is Clara and she has 2 kids in summer school).    I even saw a woman dressed to the nines look me up and down, disapprovingly because I "appeared" to be just a worker.

I know that for many people each day is a battle. I know it's hard sometimes to be polite, but making someone else feel as if she is a human with dignity, and worth acknowleding, if even just for a brief second, is the right thing to do. Best of all, it's free.