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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.
The Personal Care Products Council recently voiced its approval of Congress' plan to increase the funding for the review of cosmetics by the FDA.
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
Electronic submissions can be made at: www.regulations.gov or www.fda.gov/dockets/ecomments.
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
The Abbott Laboratories drug Humira (adalimumab) has been given expanded approval by the U.S. Food and Drug Administration to slow structural joint damage in people with psoriatic arthritis. The condition affects people who have skin psoriasis.
Humira was initially approved for overall treatment of psoriatic arthritis in October 2005. It's also been sanctioned to treat moderate-to-severe rheumatoid arthritis, and an inflammatory disease of the spine called ankylosing spondylitis.
Psoriatic arthritis combines symptoms of arthritis—including joint pain and inflammation—with those of psoriasis, including painful red lesions on the skin. Clinical testing on 313 people who hadn't responded to NSAID therapy found that people given Humira had significantly less joint damage than study participants who took a non-medicinal placebo, Abbott said in a statement.
People who took Humira also demonstrated increased ability to perform daily functions such as getting dressed, walking, and climbing stairs, the company said.
HealthDay News, November 14, 2006
The Cosmetic, Toiletry, and Fragrance Association (CTFA) announced today that it has filed comprehensive comments with the Food and Drug Administration (FDA) on the science and regulation of nanoparticles in personal care products. CTFA comments, which can be found at www.ctfa.org, specifically address issues raised in a petition filed with the FDA earlier this year on the use of nanotechnology in personal care products, in particular, sunscreen products.
“Nanoparticles in sunscreens are very small particles that have been reviewed and approved by FDA. They have been used safely and effectively by consumers for decades to protect from harmful UV rays and to prevent skin cancer,” said John Bailey, executive vice president for science at CTFA and former FDA official. “These ingredients have properties that provide a greater degree of protection from the sun, are transparent when applied and aesthetically pleasing, and therefore encourage greater consumer acceptance.”
The nanoparticles in sunscreens, titanium dioxide and zinc oxide, are established, efficacious sunscreen filters that have been on the market for decades. In 1996, FDA concluded that smaller, micronized particles of titanium dioxide are not new substances and that there is no evidence demonstrating that these micronized particles are unsafe. Nano-sized titanium dioxide and zinc oxide, unlike the larger particle size ingredient, form a transparent rather than a thick, white coating, which leads to greater consumer acceptance and use of sunscreen products, and therefore greater protection from skin cancer and other damaging effects of the sun. The same improvement in formulation esthetics also applies to the use of these materials in cosmetics.
“Nanoparticle ingredients in personal care products sit on top of the skin, are used in small amounts, and are not absorbed into the body. The general scientific consensus is that there is no risk to human health. But we don’t rest on this knowledge alone,” Bailey said. “We take the science of safety very seriously, and that is why we review the latest and most comprehensive scientific research, including nanotech research, before bringing a product to market.”
According to widely accepted independent research studies, the size of these nanoparticles does not make them inherently different in terms of toxicity or impact on human health than larger particles. It is also important to note that humans have long been exposed to some types of nanoparticles in the atmosphere such as smoke from candles, fireplaces and other sources.
In the case of the sunscreen ingredients zinc oxide and titanium dioxide, the overwhelming weight of the scientific evidence states that these substances are safe and non-toxic, including when used in cosmetics and sunscreens.
Authoritative bodies that have thoroughly reviewed titanium dioxide and zinc oxide include:
- The FDA:
Concluded that these substances are safe for use in cosmetics. Titanium dioxide has been approved for use as a color additive in food, drugs, cosmetics, and contact lenses. Zinc oxide is approved for use as a food ingredient, a color additive in drugs and cosmetics, and as a protectant for injured skin.
Concluded that these substances are safe for use in OTC drug products, including sunscreens, skin protectants, and other products.
- The Scientific Committee for Cosmetic Products in the European Union:
Considered more than 100 titanium dioxide safety studies and concluded that these substances are safe for use in cosmetics.
- Germany BfR, Federal Agency for Risk Assessment:
In 2006, reviewed these two substances and found that the nanoparticles did not penetrate the skin, and that the biological properties of the nanoparticles were not necessarily different from those of larger particles.
- The Australian government Department of Health and Aging:
In 2006, published a comprehensive review of the science on zinc oxide and titanium dioxide and found no evidence that sunscreens containing these materials in nanoparticle form pose any risk.
“The FDA has broad authority to ensure that personal care products and ingredients utilizing nanotechnology are safe for consumers and has consistently exercised that authority,” CTFA’s Bailey added. “Sunscreens, some of which utilize sun-protecting nanoparticles, are required to go through an extensive pre-market review process to prove they are safe and effective.”
The FDA comprehensively regulates the safety of consumer health products. Under the Federal, Food, Drug, and Cosmetic Act (FFDCA), FDA has erected a complex and comprehensive regulatory system to safeguard the public health. This regulatory system has worked to ensure that, among other things, the food eaten by US consumers, the medical technology used by physicians and patients, and the personal care products used by countless citizens are among the safest in the world.
Based in Washington, D.C., CTFA is the trade association representing the cosmetic, toiletry, and fragrance industry in the United States and globally. Founded in 1894, CTFA has a membership of approximately 600 companies including manufacturers, distributors, and suppliers of the vast majority of finished personal care products marketed in the United States.
The Cosmetic, Toiletry, and Fragrance Association (CTFA) is requesting public comments by September 25, 2006, on a new Safety Evaluation Guideline addressing the topic of Skin Absorption.
The guideline describes in vitro test methods for evaluating skin absorption.
The CTFA Safety Evaluation Guidelines provide manufacturers with guidance regarding the use of preclinical and clinical safety testing as a means to substantiate the safety of both ingredients and finished cosmetic products. They are part of the CTFA Technical Guidelines series.
Each Guideline undergoes an extensive development and review process by CTFA technical committees and staff, as well as public review by CTFA member companies, nonmember companies, federal government agencies, and scientific professional societies.
An electronic copy of the draft guidelines is available from the CTFA Public Affairs Department by contacting Lisa Powers, (202) 446-0489 or email at email@example.com.
The FDA is seeking to ban over-the-counter sales of skin bleaching drug products.
The FDA cites the possible risk ofand skin discoloration from hydroquinone typically found in these products.
However, those cancer studies were done on rats, not people.
"The actual risk to humans from use of hydroquinone has yet to be fully determined," the FDA states in its proposal, published in the U.S. government's Federal Register.
The type of skin discoloration noted by the FDA is called exogenous ochronosis, a darkening of the skin. The FDA cites research linking the condition to hydroquinone use.
The FDA isn't proposing a ban on prescription skin bleaching drug products. But all such products would need to submit a new drug application for the FDA's review.
Not all skin lighteners contain hydroquinone. The FDA knows of 200 products containing hydroquinone in strengths from 0.4% to 5%, about two-thirds of which "appear to be marketed as OTC [over-the-counter] drugs," says the FDA.
The FDA is taking comments on its proposal until Dec. 27.
WebMD spoke with dermatologist Susan Taylor, MD, of Society Hill Dermatology in Philadelphia, and the Skin of Color Center in New York about the FDA's proposal.
"I feel that hydroquinones are safe and effective treatment for pigmentary disorders," Taylor says. "I feel comfortable recommending that my patients continue to use hydroquinones if they have a pigmentary disorder."
"I think the evidence is quite weak with the link between hydroquinones and cancer," Taylor tells WebMD.
"Data on rats and mice cannot necessarily be extrapolated to human data," she says.
"In Africa, people have used hyrdoquinones for long periods of time ... meaning years, 10, 20, 30, years ... and at high concentrations," Taylor says. "We've not seen a proliferation of various types of cancers reported from that population.
Exogenous ochronosis is rare in the U.S., Taylor notes.
"If you look at the case reports, it's probably less than 200," Taylor says. "So it's really not a significant problem here in the United States."
Millions of Users
Taylor points out that "many patients have disorders that are truly disfiguring and devastating. And these conditions can be improved significantly with hydroquinone products."
"It's important therapy and it's used by millions and millions of people," Taylor says.
She says hydroquinone products are primarily used to lighten dark areas of the skin due to conditions including injury,, , and sun damage.
"So there are real problems and this is a real solution," Taylor says. She adds that filing new drug applications can cost millions of dollars.
"My concern is that we could lose prescription products that we have," Taylor says. "That would have major consequences, I think."
"It's safe, effective; it's the gold standard, and I think our patients would benefit from continued use for these problems. I think those three points sum it up for me," Taylor says.
SOURCES: U.S. Government Printing Office, Federal Register, Aug. 29, 2006; vol 71: pp 51146-51155. Susan Taylor, MD, Society Hill Dermatology, Philadelphia, Skin of Color Center, New York.
By Miranda Hitti, WebMD, August 30, 2006
Anthelios SX, a sunscreen that's reportedly better at blocking ultraviolet A (UVA) radiation than other sunscreens currently sold in the United States, has been approved by the U.S. Food and Drug Administration.
The product, made by the French cosmetics company L'Oreal SA, contains an ingredient called ecamsule, and has a sun protection factor (SPF) of 15, the Associated Press reported.
Ecamsule is more effective against UVA radiation than ingredients (which block mainly ultraviolet B radiation) contained in sunscreens currently sold in the United States. Ecamsule has been an ingredient in L'Oreal's sunscreens sold in Europe and Canada since 1993.
The FDA noted that UVA is a deeper penetrating radiation than UVB. There's a suspected link between UVA and long-term effects such as wrinkles, basal and squamous cell cancers and melanoma, the AP reported.
A class action lawsuit launched in Los Angeles against the five leading U.S. makers of sun protection lotions alleges that the companies lied about the effectiveness of their products in blocking harmful sun rays and protecting skin.
The lawsuit names the following brands: Coppertone (Schering-Plough); Banana Boat (Sun Pharmaceuticals and Playtex Products); Hawaiian Tropic (Tanning Research Laboratories); Neutrogena (Neutrogena Corp. and Johnson & Johnson); and Bullfrog (Chattem Inc.).
Combined, they account for 70 percent of U.S. sales of such products, Agence France Presse reported.
Mitchell Twersky, one of the lawyers involved in the legal action, said claims by these brands are "clearly misleading" insofar as they claim that "their products block all the harmful sun rays."
The lawsuit seeks to have words such as "sunblock" and "waterproof" taken off the labels of these products. It also wants the companies that make them to direct "the money that they wrongfully obtained" into a skin cancer research foundation, AFP reported.
HealthDay News, March 31, 2006