Posts Tagged ‘FDA’

The FDA’s new rules about sunscreen labeling: a parent’s guide

June 21, 2011  |  General  |  No Comments

With summer upon us, it is time to talk sunscreen. It is great for children to play in the sun. But, as most parents know, the ultraviolet rays of the sun can cause harm. The immediate potential harm is a painful sunburn; the long-term possible harm is premature aging of the skin and a higher risk for later skin cancer. The way for your child to enjoy the sun safely is to use sunscreen. But buying proper sunscreen is complicated because the labeling of these products can be confusing. Finally, after many years of studying the issue, the federal Food and Drug Administration just laid down the rules of how sunscreen is to be labeled, making it easier for parents to understand the best one to buy for their children.

Ultraviolet light from the sun comes in two forms, called ultraviolet A (UVA) and ultraviolet B (UVB). Sunburn is mostly caused by UVB. UVA can contribute to sunburn, but the main concern with this form of ultraviolet light is skin damage that can lead to premature aging of the skin and an increased risk of skin cancer many years later. Of course you would want both forms of protection for your child, but reading the labeling of sunscreen products has been difficult, and not all products protect equally. The confusion has been over the use of terms like “broad spectrum protection,” “long-lasting,” and “sweat proof” or “waterproof.”

Starting next year, any sunscreen product that claims to be “broad spectrum” – that is, protect against sunburn as well as cancer or premature aging — must block both UVA and UVB. It also must have an SPF (sun protection factor) of 15 or higher. Regarding water resistance, the new FDA rules say that the label must tell you how long the protection will last after wetting the skin – 40 or 80 minutes.

Until these new rules make it to products on store shelves, parents should check to make sure the sunscreen blocks both UVA and UVB and has an SPF value of 15 or higher. Parents should also reapply sunscreen to their children every two hours for the best protection. It is also safest to reapply it after your child has been in the water. And when you send you child out to play in the sun, remember to put a hat on them. Hats are easy, low-tech protection for necks and faces.

You can read much more about the new FDA sunscreen regulations at the agency’s site here.

Troubled times at the FDA

April 24, 2008  |  General  |  1 Comment

The FDA (Food and Drug Administration) has been battered with another serious incident, this one involving bad batches of the drug heparin (a blood thinner) that originated in China. Nearly a hundred people have died and many others experienced serious reactions after receiving heparin which appears to have been deliberately adulterated with a dangerous (and much cheaper) chemical. Until I read about it I had no idea such a large proportion of our drug manufacturing, like our clothes and our children’s toys, has been outsourced, primarily to China. In fact, now over 80% of the medicines you take, or at least the major ingredients in them, come from abroad. How can we be sure those medicines are safe?

As it turns out, we cannot — assuring the safety of these products is nigh impossible. The FDA is charged with inspecting all factories that make drugs. This was at least manageable when these facilities were in the USA, although staffing cutbacks at the FDA have even made this very difficult. In the case of foreign sites, it is unclear where some of these factories even are, and there are four times as many of them as there were 25 years ago. You can read a good discussion of the FDA’s woes here.

What to do? As one knowlegable person has pointed out, playing “kick the FDA” is not the answer. At its current level of funding, the agency will never have enough inspectors to scour the globe inspecting all these facilities. Increasing this surveilance will cost money. Where should that money come from? Drug manufacturers have reaped the financial benefit of outsourcing — I think it is time they either shoulder a major share of insuring the safety of our medicines, or else bring the manufacturing process back to this county where at least it will be easier to monitor. The recent heparin tragedy shows us what can happen if we do not do this.