Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements

Products alleged to be adulterated under the Federal Food, Drug, and Cosmetic Act

At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.

The dietary supplements seized were marketed and distributed on-line and in retail stores under the names "Methyl 1-D," "Methyl 1-D XL," and "Formadrol Extreme XL."

The seized products previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury.

"The FDA takes seriously its responsibility to protect Americans from unsafe dietary supplements," said Margaret Glavin, FDA's Associate Commissioner of the Office of Regulatory Affairs. "Wednesday's action shows FDA's commitment to protecting consumers from potentially harmful products."

"Working with the FDA, we are taking prompt civil action to protect the public health by seizing these illegal products and forestalling their shipment into the stream of commerce in any manner that could create harm to the public," said U.S. Attorney Stephen J. Murphy. "I commend the professionalism and swift action of the FDA investigators who discovered and investigated this serious problem, and I am glad our lawyers could provide the legal muscle needed to support the seizure."

FDA has not received scientific information on the safety of the seized products and cannot determine, at this time, whether they represent a hazard to consumers. Therefore, consumers who still have the products should strongly consider discussing the use of these products with their health care professionals. FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products' use. Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.FDA.gov/medwatch/report.htm.

On March 2006, the FDA warned Legal Gear (the predecessor of LG Sciences) to cease distribution of a different product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids.

Complications of Seasonal Allergies With Other Respiratory Conditions

FAQ: Complications of Seasonal Allergies With Other Respiratory Conditions With Henry Milgrom, MD & Lanny J. Rosenwasser, M.D

While most people gratefully welcome the longer days and warmer weather of spring, more than 35 million Americans dread the itchy eyes, runny nose, and sneezing that comes with the season’s pollens and mold spores.

Seasonal allergies can be especially difficult for those people who also suffer from asthma, COPD, or other respiratory diseases. Fortunately, there are more treatments than ever to help relieve allergy symptoms and make breathing as easy and comfortable as possible. New non-sedating antihistamines and nasal steroids can help relieve symptoms of hay fever and other allergic conditions so you can once again enjoy spring.

National Jewish the nation’s number one respiratory hospital and is also a world leader in allergy research and treatment. See how our doctors respond to frequently asked questions concerning hay fever (seasonal allergic rhinitis) and complications with other respiratory diseases.

Hay Fever, COPD, Emphysema, Chronic Bronchitis, and Asthma

Question: What can we expect during allergy season for our 8 year old daughter who has recently been diagnosed with emphysema? She is using albuterol and Flovent as well as bactrium, Prevacid and Reglan.

Dr. Rosenwasser's Answer: Emphysema is rare in an 8 year old, so other diagnoses may also be under consideration. Allergies are a common problem that can complicate other respiratory problems, like emphysema and cystic fibrosis. If allergy is a true problem, it should be diagnosed appropriately and treated independently of the other problems.

Question: I have COPD and problems with my sinuses. I currently use Claritin-D. Is there another medicine that will work better to clear up the drainage? I am also on Serevent, Atrovent, Proventil and Uniphyl. I rarely take Proventil.

Dr. Rosenwasser's Answer: Claritin-D can help sinus drainage for people with allergy and sinus drainage problems. Other antihistamines and decongestants can work including Allegra-D and Zyrtec. There are also over-the-counter antihistamine and decongestant combinations that help with sinus drainage. These medicines, however, would have no direct effect on COPD – the medicines you are already taking are treatment for COPD.

Question: I have emphysema and struggle with shortness of breath this time of the year due to allergies. What treatments and medications are recommended for those with COPD and heart problems (I had open-heart surgery nine years ago)?

Dr. Rosenwasser's Answer: Standard treatment for allergies should help when they complicate COPD. The standard treatment for nasal allergies includes nasal washes, antihistamines and steroid nasal sprays.

Question: I have a mother-in-law who lives in Napa, CA. She has bad asthma and wants to move out of California. Is there a list that shows the "best places to live for asthma suffers"? If so, can you direct me to it?

Dr. Rosenwasser's Answer: There are no lists of good or bad places to live with asthma. Since asthma can be triggered by things such as allergies, air pollution, and climate. There may be variations in these factors that can influence asthma control. For allergies caused by pollens there may be a short honeymoon from allergies when some one moves to a new place. However within a few years people get sensitized to new allergens.

Question: I recently moved to Denver from the West Coast and my asthma is much better here. I travel a lot for business, usually to the West Coast, and my asthma is worse again. What is the difference?

Dr. Milgrom's Answer: Because of its dry air and high altitude, Denver is free of the house dust mite. The house dust mite is a major allergen causing asthma flare-ups on the West Coast and in other humid areas of the country. This probably explains why you do well in Denver and suffer relapses of asthma when you travel.

Question: Why is it that some children only get sick with asthma in the wintertime? Should I always start my child on inhaled steroids in August? And leave him on them until March?

Dr. Milgrom's Answer: Good question. The most likely explanation is that your child's asthma flare-ups are caused by viral infections. These tend to be most common in the wintertime. A less likely explanation is that your child is allergic to indoor allergens such as molds, animal danders and house dust mites. The increased exposure in wintertime is caused by spending more time indoors and keeping windows closed. It is very reasonable to put your child on preventive therapy such as inhaled corticosteroids in the winter if you know from past experience that he is likely to have increased symptoms at that time.

Question: My respiratory allergies result in recurrent development of polyps in my nose and sinuses. I've recently had a fifth operation on my sinuses, just to remove the polyps this time. My ENT physician has suggested that I use Singulair to inhibit the growth of polyps. (I regularly take either Allegra or Claritin, and I also have asthma which is fully controlled by four inhalations of Vanceril and four inhalations of Intal each day.) Do you think that Singulair or other medications might reduce the recurrence of Polyps?

Dr. Rosenwasser's Answer: Yes, it is not published yet but Singulair and Accolate can help sinusitis and polyps.

Question: Can people with COPD take Allegra? I know Sudafed and others are not recommended for COPD patients.

Dr. Rosenwasser's Answer: People who have allergies as well as COPD can take antihistamines for their allergies. Sudafed is a decongestant and a different type of medicine.

This information has been approved by David Tinkelman, M.D. (January 2005).
Note: This information is provided to you as an educational service of National Jewish. It is not meant to be a substitute for consulting with your own physician.
© Copyright 2008 National Jewish Medical and Research Center

FDA Seeks Civil Penalties from Calif. Device Maker

The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

The agency's complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.

The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.

On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant hearing aid surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices.

The complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.

Advanced Bionic's alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used.

The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.

FDA's complaint states that the company's failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.

Advanced Bionics, LLC, is located in Sylmar, Calif.

FDA Warns Consumers Not to Use “Blue Steel” and “Hero” Products

Products are illegal drugs and pose serious health risks

The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They’re touted as “all natural” and labeled as dietary supplements. However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.

"Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, these men may seek products like Blue Steel and Hero because the products are marketed as "all natural" or as not containing the active ingredients in approved ED drugs.

FDA chemical analysis revealed that both Hero and Blue Steel contain substances that are similar in chemical structure to sildenafil; however, they are not components of an FDA approved drug. Additionally, the products’ label do not list any of these substances.

The FDA advises consumers who have used either of these products to discontinue use and consult their health care professional if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. The FDA recommends that consumers should talk to their health care professional about FDA‑approved treatments for erectile dysfunction. The FDA may take further regulatory actions to protect consumers from these illegal products.

Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules. Both products distributed by Active Nutraceuticals or the Marion Group, Carrollton, Ga.

HIV/AIDS Education in America (MWV14)

In this episode of MicrobeWorld Video we ask some leading researchers, education specialists, and public health officials about the state of HIV/AIDS education in America and ideas they have to support the teaching of microbial evolution using the latest HIV/AIDS research ó all while instilling innovative prevention strategies.

Filmed at a forum for educators on February, 11, 2008 at the Koshland Science Museum in Washington, D.C. and at San Diego State University, this episode features the following experts:

Roland Wolkowicz, Ph.D., Assistant Professor, Department of Biology, San Diego State University, whose research focus is on the use of random peptide libraries and other chemical genetics approaches for the study of viral pathogenesis and the search of antiviral factors in HIV1 and HCV.

Shannon Lee Hader, M.D., MPH, Director of the HIV/AIDS Administration for Washington, D.C., an epidemiologist and public health physician who has worked with HIV-infected children and adults in Brazil, Jamaica, and Zimbabwe.

Anila Asghar, Ph.D., Assistant Professor of Education at Johns Hopkins University, whose research focuses on curriculum development and evolution.

Educational resources mentioned within the video can be found online at:

Koshland Science Museum
http://koshlandscience.org/teachers/webquest.jsp

NIH Curriculum Guide
http://science.education.nih.gov/supplements/nih1/Diseases/default.htm

Howard Hughes Medical Institute
http://www.hhmi.org/biointeractive/