Drugs or Cosmetics?

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.

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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.

Understanding Biosimilars

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.

Remedies for Cracked Heels

August 15, 2016

Anyone can get cracked heel but some people are more prone to the condition than others. Some individuals suffer dry, cracked heel due to poor hygiene. The person may not exfoliate daily or moisturize well enough. Additionally, it could occur because the person is not drinking enough water. Each of these factors may contribute to dry, cracked heel.

The first sign of getting cracked heel is the development of dry, hard, thickened skin around the rim of the heel. This is called a callus and may be yellow or dark brown discoloured area of skin. Initially small cracks over the callus are visible.

If left untreated and as more pressure is placed on the heel, these cracks become deeper and eventually walking and standing will be painful. The cracks may be so deep that they begin to bleed. That is why it’s important to take care of your skin even on feet and find an appropriate remedy for cracked heel.

Severe heel infections may require that individuals take oral anti-fungal medication in order to alleviate or cure the symptoms. The most common ingredients in prescription anti-fungal drugs include ketaconazole, itraconazole, naftifine, and nystatin.

Those who desire a topical treatment should not simply select an anti-itch ointment. These ointments may promote moisture and exacerbate the condition. Experts recommend the use of gels instead of creams for application of topical treatments.