December 8, 2016
Several risks are involved with using indoor tanning products. For instance, if you use an indoor tanning booth or bed, you are exposing your body to UV (ultraviolet) radiation, which promotes skin damage, eye injuries, melanoma and other skin cancers.
Because of the gradual impact of UV radiation, it places children, adolescents and young adults at a higher risk for eye and skin conditions in their later years. The FDA is determined to minimize the damage of UV radiation caused by indoor tanning products by prohibiting the use of these products by people under the age of 18. Also, indoor tanning sites are required to provide literature about the possible risks associated with using an indoor tanning product and have the consumer acknowledge the awareness of such risks by signing an acknowledgment form.
The FDA is also considering another rule that will require makers of indoor tanning products and tanning sites to create more proactive strategies to prevent injuries from using these products.
Dr. Markham Luke, dermatologist and deputy office director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health tells us that using indoor tanning products at a young age (childhood and young adulthood) increases the potential to develop melanoma and other forms of skin cancer. Markham also states that several hundred youth each year in the US get injured from using an indoor tanning product.
The American Academy of Dermatology states that exposure to indoor tanning products make people 59% more likely to have melanoma than people who have never used an indoor tanning product.
Studies conducted by the Centers for Disease Control and Prevention (CDC) between 2003 to 2012 conclude that there are over 3,000 emergency room visits in the US alone due to indoor tanning product-related injuries. Interesting enough, over 400 of the patients were adolescents under the age of 18.
Things to Keep in Mind for those Still Planning on Using an Indoor Tanning Product
Now the FDA has taken steps to prevent injuries to minors who use tanning products. FDA-approved products will carry a disclaimer that prohibits the use of the tanning product by people under the age of 18. Indoor tanning products are required to have a visible, black-box disclaimer that people under age 18 should not use the product. Also keep these points in mind:
- Being exposed too long (like near the maximum time for the tanning device) can cause sunburn. Since it takes from 6 to 48 hours to realize your skin is sunburned, it’s going to be hard to tell if you’ve stayed exposed for too long.
- If you take medications or use certain cosmetics, it may make you sensitive to the sun (UV radiation actually), so consult your physician or pharmacist prior to using a tanning product.
- Neglecting to wear protective goggles while doing indoor tanning can cause temporary or long-term eye problems.
- Always follow the directions for the tanning product. If you have skin that easily burns or is hard to tan (or does not tan at all), then it is highly recommended you do not use an indoor tanning product.
October 14, 2016
When your child next has ear pain the FDA wants to ensure they get only FDA approved prescription drugs that are effective and safe for your child.
The FDA is telling companies to cease marketing sixteen unapproved prescription drugs which have labels indicating they relieve swelling and ear pain. These drops contain active ingredients like hydrocortisone and benzocaine, but the FDA has not evaluated them for safety, quality, and effectiveness.
Pharmacies as well as health care providers have sold drugs that had labels which didn’t disclose that the product wasn’t approved by the FDA. Charles E. Lee, M.D of the FDA says that we don’t know if the drugs have any benefits and we can’t accept the chances that they may have risks.
Why FDA Is Taking Action at this Time
The FDA has its Unapproved Drugs Initiative, so it’s taking action. The FDA seeks to protect consumers from drugs that aren’t proven to be safe, of high quality, or effective.
It’s a risk to public health when a drug isn’t shown to be effective, especially if it has some safety concerns. The FDA has received reports that state the products can cause mouth, face, neck, eye, and ear local allergic reactions. Other symptoms can include burning, stinging, itching and irritation of the ear.
Unapproved ear drug products which require a prescription containing these ingredients are covered by the action of the FDA:
- benzocaine and antipyrine
- benzocaine, antipyrine and zinc acetate
- benzocaine, chloroxylenol and hydrocortisone
- chloroxylenol, pramoxine and hydrocortisone
- chloroxylenol and pramoxine
The quality of the drugs isn’t known for certain. When a drug is approved by the FDA, the drug manufacturing process is reviewed which ensure that the drug is of purity ad well as consistent quality. These unapproved ear drops have not been examines in this way. The products are prescribed for infants and small children so this is troubling. Drugs that are intended to be used on children should be tested in children. The drugs mentioned haven’t bene shown to be effective in anyone so there’s no proof that the products actually work.
Alternatives Approved by the FDA Available
There are other treatment options available for children with ear problems. The FDAs action only impacts a small percentage of drugs prescribed to treat otitis externa (outer ear infections), excess buildup of earwax, and otitis media (middle ear infections). There’s also F many OTC products available that can be used for earwax buildup or swimmers ear.
There are other solutions for ear problems and choices for consumer sot make. You need to use the products that are known to be safe and avoid the ones that haven’t been test fully for safety and effectiveness.
September 27, 2016
The number of children that smoke cigarettes is down, but the number using other tobacco products is up. The National Youth Tobacco Survey (NYTS) in 2014, claimed that this was the case. The Centers for Disease Control and Prevention (CDC as well as the FDA, co-conducted the survey.
Chief of epidemiology at FDA’s Center for Tobacco Products, Benjamin J. Apelberg, Ph.D said that this is the only nationally representative survey of high school and middle school students focused on tobacco use. The results of the survey provided a snapshot of what high school and middle school students are using and trends that are emerging over time.
The findings include:
- In 2104, one in thirteen middle school students and one on four high school students said that they had been regular tobacco users, meaning that had used one or more tobacco products in the previous thirty days.
- During the survey the then 4.6 million youth tobacco users, 2.4 million were using e-cigarettes.
- The percentage of students using cigarettes decreased 15.8% to 9.2% between 2011 and 2014.
- Hookah and e-cigarette use increased drastically between 2011 and 2014.
- Around 2.2 million students reported using two or more tobacco products in 2014.
The survey started to collect e-cigarette use in 2011, but by 2014, their use surpassed every other tobacco product. This includes even regular cigarette use. High school and middle school children are using novel products like hookahs and e-cigarettes in larger numbers and many are using more than one tobacco product.
Epidemiologist Catherine Corey of the FDA say this is both good and bad. Cigarette smoking is decreasing, but hookah and e-cigarette use is increasing and it undermines the progress in the reduction of tobacco use.
Nicotine Can Impact the Developing Brain
Nicotine is highly addictive and it’s dangerous for children. It doesn’t matter if it comes from a hookah, cigarette, cigar or an e-cigarette. When the brain is still developing and adolescent is in a vulnerable position when it comes to nicotine use. Research shows that exposure to nicotine can be harmful because there are many other chemicals present in tobacco products that are linked to disease. Children and youth should not be using tobacco products in any form at all.
The FDA has regulatory authority over cigarette tobacco, cigarettes, smokeless tobacco, and roll-your own tobacco. The FDA is working on finalizing a rule that would extend its reach to other products that meet the legal definition of a tobacco product like cigars, hookahs, and electronic cigarettes. The FDA wants a minimum age of 18 for anyone looking to buy tobacco.
The new findings strengthen the evidence provided by science that novel tobacco products like hookahs and e-cigarettes have appeal to youth and that there needs to be prevention efforts to help stop smoking and cut down all use of tobacco products not just regular cigarettes.
September 18, 2016
On a Nutrition Facts label, you may have seen the amount of Trans-fat listed, but don’t know why this is even there.
The intake of Trans-fat is linked to increases chances that you’ll develop heart disease since it promotes the buildup of harmful plaque in the artery walls which may lead oy a heart attack. The FDA requires that Trans-fat be declared on any food labels so consumers know how much Trans-fat that they are consuming. Many foods that are processed have PHOs or partially hydrogenated oils which is the major source of industrially-produced Trans-fat that we find in our processed foods.
The FDA is taking a step to remove the artificial Trans-fat from our food supply. This should reduce the instances of coronary heart disease and prevent thousands of fatal heart attacks which occur each year.
Not Recognized as Safe Now
The FDA made a preliminary determination in 2013, that PHOs we no longer GRAS or “generally recognized as safe.” The FDA is finalizing its actions and determining that PHOs can no longer be called GRAS and should not be used in foods.
Scientific evidence was use dot make this determination as well as the advice given by expert panels according to Director of FDA’s Center for Food Safety and Applied Nutrition, Susan Mayne, Ph.D. Studies have indicated that nutrition and diet play a role in preventing serious health problems such as heart disease. The health of Americans is improved by updating the Nutrition Facts label.
Trans-fat dies occur naturally in dairy and meat products so it won’t completely be gone. It’s also found in small amounts in edible oils when it’s created during the manufacturing process. Companies are able to petition the FDA to use certain partially hydrogenated oils in manufacturing.
PHOs and Trans-Fat
The primary source of industry produced Trans-fat is PHOs. These are found in many popular processed foods, frozen foods, and baked goods that Americans eat. Since the 1950s PHOs have been used to increase favor and shelf-life of processed foods.
Many studies over time have shown that Trans-fat is linked to heart disease. The National Academy of Science’s Institute of Medicine in 2012 issued a report that found a direct correlation between increased levels of low density lipoprotein (LDL) cholesterol and the consumption of Trans-fat. This “bad cholesterol” increases the chances of heart disease.
In January 2006, the FDA began to label Trans-fat on the Nutrition Facts label. Many companies began to eliminate Trans-fat or change their food formulation in response to this. Consumers no know more about Trans-fat and are making better food choices.
September 9, 2016
In the U.S. last year, 136,000 people were diagnosed with colorectal cancer and 50,000 died of the disease according to data from the National Cancer Institute. This is the second leading cause of death in the U.S. It tend sot his some groups more than others. On minorities, the toll is very high according to director of FDA’s Office of Minority Health Jonca Bull, M.D. Populations that don’t get a lot of screening or get early treatment, die earlier. This impacts Hispanics, African Americans, Alaska Natives, and Indians. Early detection, treatment and referral can reduce the disparities in deaths from the disease.
Lives are Saved through Screening
Precancerous growths or polyps are the beginnings of colorectal cancer in the large intestine of the rectum. People that have signs of colorectal cancer or precancerous growths don’t always have any symptoms of the disease. Screening is important because suspicious tissue and growths can be removed before they turn into cancers.
How and When Should I get screened?
At age 50 you should get screen if you have any risk factors or developing colorectal cancer. People that are at a higher risk may need to get screened earlier on in life and may have to get more frequent screening. You can speak with your doctor to see what the best option for you. Several of the options include:
- Colonoscopy – This is where a thin tube containing a light is inserted to look at the rectum and the colon for any growths, cancer, or abnormal tissues. You are sedated for this test. Routine screening needed every 10 years.
- Flexible sigmoidoscopy – The doctor uses a thin tube and a light to look in the lower third of the colon as well as the rectum for abnormal tissues, growths or cancers. The thin tube may also include a tool which takes abnormal tissues for further examination. Routine screening is needed every 5 years.
- Fecal blood test (gFOBTor FIT test) – You use a home kit provided by your physician and take a sample of your stool and take it to the lab. The sample is checked for blood and signs of cancer. If there’s blood, a colonoscopy is needed to determine the cause. Screening is needed once per year.
- Stool (DNA test ) – you use a kit provided by your physician and provide a stool sample for the lab. It’s checked for genetic changes as well as blood. If there’s a positive test then you’ll need a colonoscopy. Routine screening is needed every three years.
- Computed tomography colonography or “virtual colonoscopy” – This test is an X-ray imaging procedure which provided 3D and 2D views of the colon from the rectum as well as the lower end of the small intestine. There’s also some visualization of the small bowel. The colon is gently inflated with air through a small tube tip which is placed in the rectum. Routine screening is needed every 5 years.
Talk to your physician about regular colorectal screening procedures.
August 28, 2016
Americans spend quite a bit of money on lotions, creams and cosmetic products that offer a promise of improved eyelashes, hair and skin. In many cases, these promises go too far in what they have to offer the consumer.
The FDA or Food and Drug Administration warns those that make cosmetics to be careful when they make claims about product and to classify them as drugs and not cosmetics. The FDA has sent warning letters citing drug claims associated with hair care, topical skin care, eyebrows, and eyelashes. These claims were found on websites as well as product labels. Some examples of drug claims are for dandruff treatments, acne treatments, as well as restoration of hair.
The letters say that the products on the market have drug claims. Meaning that the product is intended to prevent or treat a disease or change body functions or structure. The FDA wants companies to remove drug claims from products or seek the FDA approval to market cosmetic products as drugs.
Consumers need to know that drug claims on these products are not approved by the FDA when they decide to buy one of the products says MPH, director of FDA’s Office of Cosmetics and Colors, Linda M. Katz, M.D. The FDA must evaluate the products as drugs before the company can claim that the product treats skin problems or changes the skin.
Drug claims have gone as far as to say the product changes elastin or college of the skin. Other claims include that the product prevents wrinkles or allows for firmer and more elastic skin.
Some products say that there’s regeneration of cells, reduce inflammation, less facial muscle contractions or give you the same results as surgery or injections. Conditions like psoriasis, eczema, rosacea, and acne are promise dot be treated.
Drugs or Cosmetics?
The federal law sates that a cosmetic is designed for beautifying, cleansing, altering appearance or promoting attractiveness. The FDA is not required for approval before these products go to the market.
Drugs are defines as products intended to cure, diagnose, mitigate, prevent, or treat a disease or condition. A drug is also said to affect the structure or function of the body. Drugs need FDA approval in most cases before they can be marketed to consumers.
Many companies have crossed the line and stated that their products will enhance a person’s appearance or that the structural appearance of the skin and will prevent or treat certain medical conditions.
For several years the FDA has been tracking claims that have been made about cosmetic products and there are many claims on the Internet or on product packages that simple aren’t true. If a product is making a drug claim then they have to be evaluated as a drug and not a cosmetic product.
If a company can’t comply then more action besides a warning letter is taken and the product may be removed from the marketplace altogether.
August 20, 2016
The marketplace for medications is about to get a lot larger. The FDA recent approved the first biosimilar product called Zarxio (filgrastim-sndz) and expects to approve more of them soon.
Associate Director for Therapeutic Biologic Leah Christly, Ph.D., says we need to understand biological products before we can understand biosimilars.
Biologics are medications we make from living organisms. This can include animal, humans or microorganisms like bacteria or yeast. These are different from conventional medications which are usually made from chemicals or are chemically synthesized and have an easy to define structure.
Biologics aren’t made by following a chemical recipe as they come from living organism which vary in nature. These are more complex and not easy to characterize or define. They need a more complex process to manufacturer.
The FDA thoroughly and rigorously evaluates a biologic just like they would do for a regular drug before it gets approval. These biologics are the fasted growing segment of the market for prescription drugs.
A biosimilar is a type of biologic that is very similar to an already FDA approved biologic which is called the reference product. The biosimilar is not just a generic drug. The structure is very complex and it’s not easy to produce as a generic drug. The biosimilar isn’t a copy of another biologic, it’s just very similar to it.
Before any biosimilar is approved by the FDA. It’s verified by experts to make sure there are no clinical meaningful differences between the reference product and the biosimilar.
The biosimilar must also have the same dosage form and strength as well as route of administration as the reference product. The Current Good Manufacturing Practices must be used in the manufacturing of the biosimilar.
FDA approved biosimilars are effective and safe and patients can rely on them. A physician must approve the biosimilar just like they need to approve a biologic. In the marketplace for medications the biosimilar products will create greater competition. This will increase the number of treatment options for patients and lead to less expensive alternative therapies when compared to regular treatments. There are many biosimilars on the market now and consumers get an effective and safe treatment when they use the product at lower costs to them.