The FDA as Activist

The U.S. Food and Drug Administration, recently accused by consumer groups of being too permissive toward the industries it is supposed to police, was the activist last week in a variety of fields. Items: P:Americans buy 40 million pairs of prescription eyeglasses a year and an uncounted number of ordinary sunglasses. Now, anyone purchasing a new pair is likely to find that the price has suddenly gone up by $3 to $5. This is no evasion of Phase II, but the result of an FDA order that makes it illegal in all 50 states to sell eyeglass lenses that are not "impact resistant." The stronger, safer glass costs more.

The FDA, which set the new requirement to reduce eye injuries, was precise in its standards. The lenses will not be unbreakable or shatterproof, but they must be sufficiently tempered to withstand a specific shock--a steel ball weighing .56 oz. dropped from a height of 50 in. The optician is supposed to make the drop test, aiming at the center of the lens, before releasing the glasses.

P: The FDA also announced that it is undertaking a herculean task: the screening for effectiveness of all over-the-counter (nonprescription or "proprietary") drugs marketed in the U.S. No one knows how many there are, though estimates go as high as 500,000, counting competing brands and combinations of the same basic chemicals. The FDA has had authority since 1938 over the safety of drugs, but not until 1962 did Congress give it the power to require proof of their promised performance. The studies now beginning, scheduled to take three years, will be made by panels of non-Government experts. First to be examined will be the antacids, followed by cold preparations, pain killers and mood drugs.

P: In a surprisingly stern action, the FDA prepared to pull the plug on virtually all products containing hexachlorophene (HCP). It had already issued a warning (TIME, Dec. 20) against bathing babies with pHisoHex, which contains 3% HCP. The substance penetrates the skin and mucous membranes and has been linked to brain damage in animals--though not, as yet, in man. Touted as a killer of germs and body odors, HCP has been used in many cosmetics, shampoos, soaps and almost all deodorants, notably the "feminine hygiene" variety. Now the FDA has served notice that within 60 days it will ban all further manufacture of cosmetics with even minute amounts of HCP as an active ingredient and will limit the use of skin cleansers containing more than .75% HCP (meaning, principally, pHisoHex and hyperpHaze) to hospital and prescription use. Medicated soaps like Dial will be reviewed by one of the panels screening over-the-counter drugs.

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