Sunscreen Labels & Lawsuits - Whose Fault Is It?

Part 1

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.

Part 2

The Manufacturer

Like most businesses, manufacturers of drugs have always sought to increase sales of their products. But in this industry, a distinct history of misleading label claims to encourage purchase has always characterized marketing strategies. It is this paradigm that spawned creation of the FDA in 1906, and later the advent of the clinical trial for drugs which, in order to be approved for market by FDA, must provide a statistically significant response compared to placebo in order to earn the priviledge of market entry.

While FDA attempts to compel companies to behave, today’s corporate environment, saturated with malfeasance, demands manufacturers perform to higher standards. It is necessary to continually seek to make organizations better, cleaner, and more conscientious, and assure their operational mantra parallel the functional purpose of their products. This is particularly the case for sunscreen manufacturers who supply a product that is supposed to help protect their customers from harm. Unfortunately, proper behavior has largely been ignored.

KLRC had identified how the sunscreen mass- manufacturers regularly fail to deliver their promise:

1. Follow, instead of drive, regulatory standards when positioned to do so.

2. Failure to follow the spirit of FDA regulation and proactively adopt the new labeling standards.

3. Excessive use of harmful synthetic petrochemical sunscreens to elevate SPF level for marketing purposes makes little sense from a health perspective. For example, tripling SPF from 15 to 45 provides only 4.5% more protection yet demands up to 300% more toxic chemical exposure. These economics simply do not make sense in terms of reducing skin cancer rates, which are not surprisingly increasing.

4. Lack of conscientious marketing: sunscreen manufacturers know that sunscreen is not perfect, but the majority hasn't attempted to enhance consumer understanding that ANY UV exposure is potentially dangerous. Marketing "All Day Protection" or "Waterproof" is simply irresponsible, whether or not regulation allowed it at any point.

These behaviors represent the primary reasons lawyers are being hired now and the fight will proceed in the courts.

Kabana recognized these issues at inception, and Green Screen(tm) is its proposed solution. Our goal is to provide our customers access to as much information about our ingredients as possible. We challenge you to evaluate our products and decide yourself that they are indeed the best on the market. Kabana will always refuse to use deceitful marketing's smoke and mirrors.

Part 3

The Consumer

When protecting one’s own health, whose responsibility is it really? It’s not the FDA's, nor the manufacturer’s: it’s our own. As consumers we must all beware. It is our duty to understand how sunscreen works, and question what manufacturers say their products can do, particularly when hyperbolic language is used. (Nothing is Waterproof or Sweatproof or can possibly block the sun, as the term “sunblock” suggests, much less do any of these "all day" with a single application.) The fact is, sunscreen is imperfect – it’s designed to reduce UV exposure but cannot eliminate it completely. Kabana recommends that if a customer really wants to avoid problems caused by UV exposure, it is better to stay in the shade: buy a hat and wear clothes. Erik and Jess both wear hats whenever they’re outside for long periods; you should too.

The following Consumer Faults are Our Responsibility: