FDA Approved and Recalled Hair Loss Products

FDA Approved and Recalled Hair Loss Products
Business Hair Loss News Uncategorized

FDA Cleared
The United States Food and Drug Administration (FDA) is a federal government agency in charge of keeping the American public safe by regulating food, drugs, and medical devices. When a product or item is FDA-Approved, it has been rigorously tested and thoroughly inspected, and found to be both effective and completely safe for people to use or consume.

Avacor Physician’s Formulation® is an FDA-Approved hair restoration product clinically proven to revitalize hair follicles and help you grow back your very own hair. The FDA has carefully tested and inspected how the product is manufactured, what ingredients are used, how much of each ingredient is used, how the product is stored and packaged, and how the product is administered. In other words, all aspects of Avacor Physician’s Formulation production, including each ingredient, the bottling process, and the recommended dosage, have been deemed completely safe and effective for consumers to use for the treatment of hair loss, according to the FDA.

What’s a drug? According to the FDA (U.S. Food and Drug Administration), drugs are products that affect the structure or functions of the human body. Drugs you can purchase without a prescription are called over the counter (OTC) drugs. FDA requires that all drugs be approved through extensive clinical trials. For hair loss, they have approved two.

PropeciaPropecia (finasteride) This is probably the world’s most effective hair growth product. It’s by prescription only. It’s also for men only. It works in front and in back. In tests, 66% of men grew hair in back and 42% grew hair up front. Almost all the rest stopped losing hair. Propecia inhibits the enzyme 5 alpha reductase to decrease DHT production.

Propecia’s sexual side effects are often exaggerated. This is a perfect example of why you need to do your homework and read test results yourself. For example, 1.8% of men taking Propecia reported decreased libido. So did 1.3% of men in the test’s control group that were given a placebo. You can see the complete test results online at the Propecia website.

Rogaine_cdbe5_450x450Rogaine (minoxidil) This was the first hair growth drug approved by the FDA. Now it’s available without a prescription – extra strength for men and regular for women. Rogaine’s effectiveness is established in front and back for women but only in back (vertex) for men.
Rogaine seems to work because of its vasodilator properties. DHT shrinks and chokes follicles, and Rogaine seems to combat this by swelling the follicle’s tiny microvascular structures. This is not to be confused with a generalized increase in circulation to the scalp – a premise of many scams. If you want clinical test data, contact them and they will send references to medical journal articles.

Recall: Hair Regrowth Products Sold on Internet

All topical hair regrowth products made by Perfect Image Solutions LLC have been recalled because they are “unapproved new drugs” under FDA regulations and may be hazardous to your health.

The recalled products, which are distributed nationwide through the Internet, include:

  • Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL
  • Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL
  • Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL
  • Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL
  • Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL

Risk: Minoxidil 15% and 10% could cause low blood pressure, a rapid or irregular heartbeat, and other heart-related symptoms. Azelaic acid can make the skin where it is applied more sensitive to sunburn.

Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation or stinging.

These products are used by men and women to slow or stop hair loss and to help hair regrow. They are packaged in glass-dropper containers or plastic shampoo bottles and sold in single units.

If you have these recalled products throw them away and discontinue further use.