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Making Drugs Safe and Available without the FDA
Underwriters Laboratories: Testing in the Public Interest
Like the FDA, Underwriters Laboratories, Inc. is committed to public safety.
Both organizations work to safeguard the public from dangerous products.
Both are staffed by experts in science and technology. UL's actions affect
millions of consumers and billions of dollars, as do the FDA's. Every day,
U.S. consumers buy and use products that are "UL Listed," meaning
UL certifies that they meet its standards, or FDA-approved, meaning that
they meet FDA standards.
writers Laboratories cannot deny consumers choice."
But there are differences. UL listing means that experts have given their opinion on the safety of a product. FDA approval is a legal requirement before drug and medical device companies can market their products. Unlike the FDA, UL operates a wholly voluntary certification system and cannot compel manufacturers to submit products for testing. Unlike the FDA, UL cannot prevent products from being marketed. It cannot deny consumers choice because it is not a regulatory agency with enforcement powers. Unlike the FDA, UL receives no tax revenues. It is wholly funded by its clients, mostly manufacturers, but is independent from them.
Yet every day we put on our FDA-approved cosmetics after drying our hair with our UL Listed hairdryers. We cook our FDA-approved breakfast cereal on our UL Listed stove top. On our drive home, we take our FDA-approved aspirin while cooling off with our UL Listed automotive air-conditioner. At night, we sleep soundly, protected by our UL Listed smoke detector. Both UL and the FDA contribute to our safety and peace of mind.
What UL Does. Since 1894, UL's stated mission has been "Testing in the Public Interest." William Henry Merrill, its founder, said in 1923, "We are doing something for manufacturers, buyers, users, and property owners everywhere. We are doing something for humanity."40 [See the Sidebar on Underwriters Laboratories.]
UL conducts product safety and performance testing and certification as well as quality system registration. It also develops national and international codes and standards. Along the way, UL writes Standards for Safety that manufacturers can use to aid them in designing and marketing safe, salable products.
The only business of Underwriters Laboratories is providing information to the public. UL underwrites no risk in the insurance industry sense. It produces no testimonials, advertisements or other marketing support. UL approval requires manufacturers to issue warning labels, use-and-care booklets, safety tips and other consumer information. UL itself distributes informational literature, broadcasts public service announcements and publishes news releases to educate the public about the meaning of the UL mark.
No Delays, No Politics, No Coercion, No Monopoly. UL cannot be accused of delaying the approval of new products because it cannot keep products off the market. UL tests products and certifies their safety, providing consumers with accurate, timely information and nothing more. Consumers can decide for themselves, based on good information, whether they want to buy a riskier product or not.
Most of us gain from choices other people make on our behalf using UL's services. Based on UL approval, builders install household chimneys and fire-resistant wire for our benefit. No monopolistic government agency prevents us from making choices or deters others from making good choices on our behalf. The UL system has worked for more than 100 years!
UL demonstrates a way to assure third-party independence. Its standards are not created in a political furnace. They do not reflect political or industry special interests.
No statutory, regulatory or court-ordered mandate requires manufacturers to seek UL approval, yet tens of thousands do. Why? Because buyers want safe and effective products. UL has staked its reputation, time and continued existence on the accuracy and timelines of the information it provides. Consumers recognize this and are willing to buy, or pay more for, UL Listed products. Thus manufacturers who produce a good product want UL listing. Companies that make poor, unsafe products are not listed with UL, and many consumers avoid these goods. To know a product is safe, all the consumer has to do is look for the UL mark.
Manufacturers pay for UL services. UL charges a fee based on the cost of testing and bills for its on-site inspectors at a flat rate. Consumers who do not benefit from its services do not have to pay for them. Since it does not receive a government appropriation, UL is not pressured to comply with congressional special interests. On the other hand, UL must satisfy customers directly and is not detached from the people who use its services as are tax-supported government agencies.
If UL were merely a tool of certain manufacturers, it could not avoid listing unsafe products. Consumers would soon discover this, and the UL mark would be worthless. Manufacturers would stop paying for UL and its services. UL, consumers and manufacturers all want the organization to remain accurate and independent, and all have incentives to guarantee it.
UL does its job efficiently and at low cost. In 1994, UL employed more than 3,900 people, including more than 900 degreed engineers and many researchers and technicians. In that same year, the FDA employed 1,093 people in Commissioner Kessler's office alone.41 Revenue figures were not publicly available, but in 1994 UL had total current assets of $61,714,000.42 That is a substantial sum, but far less than appropriations for the FDA.
UL takes an active, long-term role in quality and safety assurance. For their fees, clients receive many follow-up services. These include frequent, unannounced visits to production facilities worldwide. In 1994, UL personnel conducted more than 481,000 on-site, follow-up service visits.43 During a visit, UL personnel check production controls, observe on-site testing, inspect facilities and select samples for further testing at UL labs. They even check to see if the Certification Program is posted on the wall. If the facility does not pass inspection, the manufacturer has two weeks to correct the mistakes. After that, UL pulls its certification.
Even Governments Use UL. UL also has federal agencies, states and localities as clients. For example:
- The Occupational Safety and Health Administration uses UL as a tester
and independent certifier of "hazardous location" products, and
the organizations work together to create, revise and implement standards
for products falling under OSHA's authority. In some cases, OSHA uses UL's
existing standards.44
- UL works with more than 40,000 jurisdictions across the U.S. to develop electrical, building and safety codes, and the UL mark is accepted in all 40,000.45
This close cooperation between the producers and UL allows faster production and certification of safe products. For example, Scott Ritchie, Tampa Local Engineering Service Manager, conducted safety and performance tests during a tropical storm. Gordon Beamer of ECC International of Orlando, Fla., said "I just can't believe he made it here during Tropical Storm Gordon....I wanted to make sure the new design was acceptable as quickly as possible. The people here couldn't believe Scott even got here. We were closing the plant and he was running tests."46
After a product has been submitted for testing, UL issues an outline of investigation to interested parties and solicits comments and criticism. Based on the feedback, UL amends the outline, issues the proposed standard and repeats the process. This reiteration results in the published standard. The whole process usually takes three to four months. Amendments to the standard can be published and available within a day, and UL's engineers can write a Certification Program in two weeks.47
The standards are designed to accommodate manufacturing innovation in a manner consistent with the standard's original intent. The guide to developing standards says, "[B]uilt into UL Standards are requirements that facilitate changes and eliminate undue restrictions on design. This equivalency makes it possible to convert any construction requirement into a performance requirement."48
Comparing the UL Approach and the FDA Approach. The FDA does not have published standards, nor does it tell manufacturers how to comply with requirements to get a new drug approved.49 Instead, it tells the manufacturer to hire a consultant to guide it through the process. 50
FDA Commissioner Kessler sought to increase FDA flexibility by allowing manufacturers to slightly alter the content or manufacturing process of a drug or biologic with only a brief notice to the agency instead of a full review.51 Also, the FDA plans to implement a policy that certifies safe manufacturing processes rather than specific product performance.52 Responding to the increased pace of technological innovation, UL already helps companies register facilities and quality systems worldwide.53 In other words, while the FDA is only beginning to concern itself with quality production systems, UL has already done so.
The Assurance of Good Work. During testimony before the Senate Committee on Labor and Human Resources, Kessler stated, "The assurance that the FDA is there every day, doing its job, is so fundamental that we have the luxury of taking it for granted." This statement implies that the FDA is necessary for Americans to feel secure about their food and drugs. However, Americans do not worry that their televisions will start fires or that they will be injured using their toasters. The reason is that UL is conscientious and accurate and has incentives to stay that way.
Poor quality and poor performance standards are costly for everyone, including manufacturers and UL. As UL's 1994 Annual Report states, "The 'real' cost...is compromised safety, which can ultimately result in product rejection, manufacturing delay and greater costs. A final result is the loss of the certification organization's credibility and the manufacturer's product acceptance." That means loss of clients for UL and loss of jobs for UL's management and employees - good reasons to maintain high standards.
Furthermore, UL does have competitors. They include Electronics Testing Laboratories of Cortland, N.Y., a subsidiary of the British conglomerate Inchcape, Factory Mutual of Norwood, Mass., and Canadian Standards Association of Rockville, Ontario. Some use UL standards as the basis of their certification, but others write their own. Though UL uses the term "friendly competition,"54 the competition is there. If UL's standards are inappropriate or if the consuming public loses confidence in UL, others are ready to serve the market.