National Consumers League

Health

NCL Health Issues

Considering an Rx or OTC facial anti-aging product?

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Want to turn back the clock without going under the knife? It’s always better to be an informed consumer, especially when it comes to your health! Before you select a prescription facial product, make sure you do the following.

 

  • Find a licensed dermatologist you trust. Check out the American Academy of Dermatology Web site, where you can search for an accredited dermatologist in your area.
  • Tell your doctor about your medical history, including any allergies and medications (prescription and over-the-counter) and supplements you are taking.
  • Find out how much the medicine costs and whether any of the cost will be covered by your insurance.
  • Follow the instructions for use exactly as directed by your doctor and the package.
    • Ask questions!  You will want to know:
    • How long it will take to begin seeing results
    • What risks are involved
    • What to do if you have a reaction
    • How long you can expect the results to last
    • When you should return for a follow-up appointment

Prescription facial products are products that claim to diagnose, cure, mitigate, treat, or prevent a disease or condition, and they are approved and monitored for efficacy based on the claims made by the manufacturer for their specific indications. Before a new drug may enter the market, its manufacturer must first submit a New Drug Application to the Food and Drug Administration. The application must include safety and efficacy data providing evidence that the drug does what it claims to do--and that it does so safely. The FDA has also established Good Manufacturing Practices (GMPs) to which drug manufacturers must also conform. By the time a doctor prescribes a drug to you, there's been testing and monitoring, and it's considered safe by the FDA for the specific indication. You can learn about the FDA's approval process here, or look up a specific drug here.

Before you select an over-the-counter facial product, make sure you do the following.

  1. Ask your friends and family and doctor for a recommendation.
  2. Read the label and make note of any warnings.
  3. Be reasonable: remember, if it sounds too good to be true, it probably is.
  4. Follow the instructions for use exactly as directed on the package.
  5. Ask your pharmacist to tell you about the active ingredients.
  6. Call your doctor immediately if you experience a negative reaction.

Anti-aging OTC facial products: Cosmetics or Drugs?

Consumers need to know that not all drugstore facial products (examples) are treated equally by those who monitor for safety and effectiveness. Products that are considered "drugs" by the federal government are subject to higher levels of regulation and monitoring. Products that are considered "cosmetics" have less rigid guidelines to follow. Here is a quick guide to help you determine whether your anti-aging facial product is a drug or a cosmetic -- and what that means for you!

The best way to tell whether an OTC facial product is regulated as a cosmetic or a drug is to examine the package and read the label.

If you see…

  • A statement or claim that the product can prevent, treat or cure a condition,
  • A Drug Facts Label, or
  • A list of “active” ingredients

…then the product is regulated as a drug.

Any manufacturer wishing to sell a drug in the U.S. must submit safety and efficacy data as part of its New Drug Application. Drug manufacturers also must conform to the Good Manufacturing Practices (GMPs) set forth by the FDA to guide the industry.

The distinction between drugs and cosmetics is also made apparent on the product label.  If a label makes a claim that use of a product is intended to affect the structure or function of the body, then it is classified as a drug.  More clearly stated, if a product claims to diagnose, cure, mitigate, treat, or prevent a disease, then it is treated as a drug.

Some practical examples of products that are treated as drugs include:

  • Antidandruff shampoo (because it prevents and cures the “condition” of dandruff)
  • Toothpaste (because it prevents tooth decay)
  • Sunscreen (because it blocks harmful sun rays that can lead to skin cancer)
  • Antiperspirant (because it inhibits a body function)

If you see…

  • A statement or claim that the product can beautify, improve, or alter appearance, or
  • A list of all ingredients, and
  • No list of “active” ingredients

…then the product is regulated as a cosmetic. Any cosmetic manufacturer wishing to sell its products in the U.S. can perform safety and efficacy research, but is not bound to provide that information to the FDA at any time.

If the product is labeled as something to cleanse, beautify, promote attractiveness, or alter appearance, it is considered a cosmetic.

Some examples of products that are treated as cosmetics include:

  • Regular shampoo (because it cleanses and conditions, but does not prevent a condition)
  • Deodorant (because it improves body scent)
  • Anti wrinkle cream (because it reduces the appearance of lines and smoothes the complexion)