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Regulations

New in Regulations (page 16 of 17)

Mar
19
2008

Looking for Alternatives

By Imogen Matthews

Ingredient lists and labels are facing more and more scrutiny as consumers, unwilling to accept cosmetics and toiletries at face value, seek purer, more natural alternative formulations, leading to significant growth in alternative ingredients in new launches.

Mar
12
2008

SCCP Re-evaluates Toluene and Benzophenone-3

Wet Toes

The European Commission (EC) is requesting opinions from its Scientific Committee on Consumer Products (SCCP) on benzophenone-3 and toluene.

Mar
07
2008

Changes on the Horizon in Natural Cosmetics Market

Organic Monitor is predicting 2008 to be defining year in the adoption of natural and organic standards in the skin care industry, possibly affecting a range of products and treatment options.

Feb
06
2008

PCPC Responds to Phthalates in Baby Care

The Personal Care Product Council (PCPC) has released a statement on phthalate exposure in baby care products.

Feb
05
2008

Natural, Smatural … What Does it Mean and Do We Want it Defined?

By Rachel Chapman

In the consumer’s world, natural means safer, greener, better for the environment, etc. And although this belief may not entirely be grounded in reality, the fact remains that products labeled as natural have been the force behind a major trend in cosmetics and personal care for years.

Jan
30
2008

The Green Report: The Question Begs the Answer

By Jeff Falk

Beauty industry bigwigs discuss the greening revolution.

Jan
16
2008

Cosmetics, Drugs and Labels

By Rick Van Arnam, Esq.

Failing to understand the distinction between the legal definition of cosmetics and drugs, and subsequent improper labeling or promotional claims, can be a costly error.

Jan
02
2008

Council Commends Congress for FDA Cosmetics Funding Increase

The Personal Care Products Council recently voiced its approval of Congress' plan to increase the funding for the review of cosmetics by the FDA.

Sep
19
2007

FDA Proposes New Rule for Sunscreen Products

The U.S. Food and Drug Administration (FDA) recently proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

Because sunlight is composed of both UVA and UVB rays, the organization proposes the creation of a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product, instead of only the level of UVB protection identified through SPF values.

The proposed four-star ratings system works with one star representing low UVA protection, two stars, medium; three stars, high; and four stars the highest UVA protection available in an OTC sunscreen product. If it doesn't provide at least a one-star protection rating, the FDA is proposing to require the product to bear a "no UVA protection" marking on the front label near the SPF value.

These ratings would be derived from two tests to assess the UVA deflection effectiveness. The first measures a product's ability to reduce the amount of UVA radiation that passes through it. The second measures its ability to prevent tanning.

Also, a "Warnings" statement in the Drug Facts box will be required from all sunscreen manufacturers that will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using sunscreen."

When finalized, the regulation would amend the existing OTC sunscreen rule published in 1999. It will also revise the existing SPF (UVB) testing procedures, allow new combinations of active ingredients and ask for comments of the issue of nanoparticles.

Comments of the new rule will be accepted until November 26, 2007. These must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax: 301-827-6870

Electronic submissions can be made at: www.regulations.gov or www.fda.gov/dockets/ecomments.

May
04
2007

Take Action Against Career-threatening FDA Proposed Regulation

The Day Spa Association issued a release to its members urging them to take action against a new career-threatening regulation. The U.S. Food and Drug Administration (FDA) has recently rewritten their regulations in an attempt to outlaw and eliminate alternative health care modalities. From massage to vitamins, minerals, and herbs, all alternative and complementary modalities will be labeled as practicing medicine without a license unless prescribed by a physician.

The subtle change of vocabulary from "alternative health care" to "alternative medicine" makes all of these industries subject to control by the FDA as medicine. Only medical doctors would be allowed to provide, prescribe and supervise the delivery of these services. Anybody else who provided any of these services would be practicing medicine without a license, and subject to incarceration and fines.

Click here to read the actual draft guidance.

What this means

1. By using the term "medicine" rather than "modality," for CAM practices, the FDA sets the stage so that anyone who is not a licensed physician is breaking the law by using these modalities since they are therefore "practicing medicine without a license."
 
2. By using the word "treatment," rather than "therapy," the FDA limits those who can perform these practices to licensed physicians.
 
3. By using the terms "medicine" and "treatment," instead of "modalities" and "therapy," all substances including vitamins, mineral herbs, co-factors, etc., automatically become untested drugs since they are being used to prevent, treat, mitigate, or cure disease states. Such use can only legally take place with FDA  with FDA approved drugs.
What you can do
Write to the FDA directly.
Write individual letters, call your congressman's office, or send an e-mail.
Raise awareness among your colleagues and encourage them to take action, as well.