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ROCHE CHEMICAL DIVISION     
Hoffman-La Roche Inc 
Nutley, New Jersey 07110 - (201) 235 5000

September 11, 1986

Dear Customer:

As a customer for Roche Canthaxanthin sold under various trademarks, such as
Roxanthin Red 10 WS, Roxanthin Red 10 Beadlets and Dry Canthaxanthin 10% SD,
we would like to review with you the status of this carotenoid. Canthaxanthin
is cleared under FDA regulations as a color for general food use up to a maximum
of 30 mg. per pound or pint of food; but, of course, it may not be used in foods
covered by standards of identity unless allowed by the standards. It may also
be used to color drug products in amounts consistent with good manufacturing
practices.

At this time, these are the only uses allowed under FDA regulations for this
substance in the United States in humans. The applicable regulations are 
21CFR 73.75, as to foods, and 21CFR 73.1075, as to drugs.

Presently, Canthaxanthin is not approved by the Food and Drug Administration 
for use in ingested products intended to color the human body, i.e., 
oral-tanning products.  Until the FDA gives its approval, FDA considers such products to
be illegal in the United States. Tanning products have been seized under
provisions of the Federal Food, Drug and Cosmetic Act; further, attempts to import
these tanning products have resulted in their being detained at the ports of
entry.   In view of the foregoing. it has been, and continues to be, our company
policy not to sell Canthaxanthin for oral-tanning preparations in the United
States.

If you are not already aware of the fact, you should know that in investigations
originally carried out in Canada, and more recently in Germany, a number 
of people who had been taking Canthaxanthin tanning preparations at high levels,
for prolonged periods of time exhibited as a side effect a so far unexplained
phenomenon which the authors describe as glistening, apparently crystalline
deposits in the inner layer of the retina of the eye, in particular, around the
the macula. In some of the subjects investigated, sensitive ophthalmological
tests revealed, slowing down of light-darkness adaptation of the eye, though
the clinical significance of this remains to be fully determined.

This functional disturbance is reported to regress on discontinuation of the
Canthaxanthin tanning  preparation. The deposits in the retina, however, have
not been observed to regress, but remain in place without apparent impairment
of vision, perception of color or field of vision.

Canthaxanthin is one of the more than 400 naturally-occurring and identified
carotenoid colors which have been present in food for thousands of years. For
many years Canthaxanthin has been, and presently continues to be, used as
a safe food colorant in the United States - mainly to give a red color in foods
where the natural color has been lost during processing.   In the oral-tanning
application referred to above, which had been allowed by a number of foreign
countries (but has since been banned with few exceptions) users frequently
ingested 100 milligrams or more a day for prolonged periods, which clearly
distinguishes it from the low levels encountered in food.

We appreciate your continued interest in non-certifiable Roche carotenoids for
food, dietary supplement, and drug coloring applications. If you have any ques-
tions regarding Roche carotenoids, please do not hesitate to contact us.

Cordially,




William R. Driscoll
Director of Technical Services
Human Health and Nutrition Department
Roche Vitamins and Fine Chemicals