318 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS The chlorinated phenols generally are skin irritants. Most of these if used at a sufficiently low concentration are tolerated by the general population. "Skin fatigue" is a common phenomenon in their use. Cationic surfactants which are ever increasing in popularity are also damaging to the skin and especially to the mucous membrane of the eye. There is no particular objection to their use in cosmetics provided the limits of tolerance have been carefully determined by proper pretesting. The other groups listed appear not to present any particular hazard that we are aware of at this time. Where antiseptic claims are made the prod- ucts are drugs, and may be "new drugs." ROYAL JELLY Some fantastic claims, wholly unsubstantiated, have been made for this product. Royal jelly is claimed to improve beauty and nerves, produce youthfulness and well-being as a skin food, rejuvenate worn-out glands and so on. A chemical analysis of royal jelly reveals that the amounts and proportion of sugars, protein, ]ipids, and moisture, are not unlike the con- stituents of evaporated cow's milk. A review of the literature fails to reveal any serious pharmacological study to support the many allusions to the possible beneficial effect of royal jelly in humans. ORAL COSMETICS 8-Methoxypsoralen, also known as 8-MOP, oxsoralen, meloxine and methoxysalene, is a drug advocated for potentiating suntanning and sun tolerance. To administer a substance by mouth to produce a cosmetic effect is a major medical procedure and one fraught with dangers of pro- ducing systemic effects. Much remains to be elucidated regarding the mechanism of action of 8-MOP. Likewise, little is known of its potential toxic effects. In practice only one person in seven obtains satisfactory pigmentation. In many cases pigmentation is not permanent, requiring further administration of the drug. Dosages are a delicate question, since it is relatively easy to overdose, so that on future exposure to UV light or sunlight erythema, edema, pain and even blistering may result. The effect of the drug in patients with liver or gastro-intestinal diseases is not known. It is also not known what the consequence might be if more than a normal tan develops. Effects on senile skin are not known, that is, whether normal senile changes in the skin are delayed or acceler- ated. SEVERELY Toxic DRUGS Compounds of such poisonous heavy metals as selenium, silver, lead, cadmium and arsenic have been proposed for use in shampoos and hair preparations. Although the intact skin is a good barrier to absorption of

DRUGS IN COSMETICS--SHOULD THEY MIX? 319 these severe toxicants, conditions of damaged skin and oral ingestion are potential hazards. Anticholinergic and antiadrenergic drugs have been proposed for use in antiperspirants. Such preparations should be the subject of"new drug" applications. Capsicum, cantharides and pilocarpine have been employed as compo- nents of hair tonics. These so-called hair tonics ale active primary irri- tants requiring definitive label directions. Injury reports to us from their use are not uncommon but nearly always result from overzealous use, that is, from a disregard of directions. Carbon tetrachloride has been proposed for drying hair. We caused the removal from the market of preparations containing this compound for such purpose on the grounds that they contained a poisonous substance which might render them injurious under the conditions of use. Boric acid has considerable use as a dusting powder. Although the intact skin is a good barrier to boric acid absorption, a badly damaged skin permits ready absorption. In a paper to be published it will be re- ported that the absorption of boric acid was traced through urinary excretion studies. It was possible to demonstrate that exposure of 15 per cent of body surface of rabbits with a severely damaged skin exposed for 11/2 hours to boric acid, a urinary excretion level comparable to animals receiving 200 mg./kg. orally was obtained. Boric acid cannot be rated as a minor toxic agent. SUMMARY AND CONCLUSIONS In summary, it appears that the mixing of drugs with cosmetics is likely to produce products that are classed as "drugs" under the law. They may be innocuous products such as royal jelly, which became drugs because of the intended purposes for affecting the structure or function of the body, and misbranded drugs because the labeling claims are misleading or false. Or they may contain potent substances capable of causing injury if not properly compounded and adequately labeled. Whether drugs or cosmetics, or both, it is to the interest of the industry as well as the consumer that products be safe, effective and honestly represented.