Label readers are likely to have heard about the recent lawsuits filed against many of the mainstream mass marketed sunscreen manufacturers, accusing false advertising in terms of the level of protection afforded by sunscreens. Terms such as “sunblock,” “waterproof,” and, “all day protection” are particularly under fire because they convey a sense of security that actually doesn’t and cannot exist given the nature of sunscreen formulas. In this and the next two columns, KLRC investigates how this lawsuit arose. Unlike the lawsuit's focus on manufacturers, the fault lies with three entities:
The FDA
The Manufacturer
The Consumer.
The FDA
Congress chartered the FDA to protect the American Public from mislabeled and adulterated drugs after passing the Federal Food and Drugs Act 1906, largely in response to the proliferation of patent medicines that claimed to cure all varieties of common illnesses and legitimate manufacturer’s concerns in regard to market erosion associated with such fraudulent claims. FDA is thus a governmental organization with two primary stakeholders – consumers and manufacturers. Its task is to protect the public yet allow the special interest lobby significant power to influence protection. This process has been in a state of flux since the Administration’s birth.
FDA’s major faults regarding sunscreen labeling are as follow:
1. FDA has never developed a good method of indicating how much UV protection a given formula has. This fact is concisely illustrated by how poorly consumers understand what SPF measures. Protection does NOT increase equally as SPF number increases, as consumers believe – SPF 45 affords only 4.5% more protection than SPF 15, not 300% more.
2. FDA’s UV protection measurement "SPF" focuses exclusively on the UVB burn component of UV exposure as opposed to effects of both UVB and UVA, even though UVA is equally dangerous radiation and is associated with causing several forms of skin cancer.
3. FDA allowed sunscreen manufacturers to use the terms “sunblock” and “waterproof” until a recent monograph ruling that required sunscreen manufacturers refrain from using “sunblock” and “waterproof” in their labels after a specified date, or until their inventories were depleted. The inventory clause makes this regulation functionally unenforceable since policing inventory is nearly impossible.
4. FDA doesn’t investigate labeling issues until sufficient complaints are filed. This is somewhat understandable from a bugetary perspective, however at the very least FDA policy should demand high volume manufacturers obey label law.
During this future litigation, KLRC believes a resonable Manufacturer defense will be "We were following FDA regulations." It will be interesting to see how the judicial system weighs the Manufacturer and Consumer faults, which will be the subjects of Parts 2 and 3.
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