•

•

... June 24, 1988 ',..~ J' '1

Our

Proteus Corporation dba !arthrise Company 830 Fifth Street San Rafael, CA 94901

" ... ..

' " . Public Health Service • . •

.'-·•' ,, ·Ii 'r . . ·.:··~ .,• Food and Drug Admlnlstratiof,.~ '",, \,~:··:~:/-! .( .(• • .. .

• t".! 1 , ; ;I. · . "=. .,._. .•i • Ao-

, •• ,r. ~. f •• ' ..... :...· · ,, -~· .... - '{ ...t

Attention: Robert W. Hendrikson, President .... · . :, I a ,

.... ~-

Dear Mr. Henrik.son: : · ,:,..... i :

These products are in serious violation of the Act, as follo\JS:

SECTION

5C2(a)

BRIEF DESCRIPTION "' ' • ti •• t•

!iisbranded in that the ::..abeling 'tor: ,~,.~. >i::,· ': . :"'::·:\. ''•'';. . . . . , ... ;- . •·.: .: .. ,\ .. , . '• . . ..

( 1) Imun-N-;:S~re1.Cold's . & ~lu~ Season Pro.tec.tfon • ,,~ • Fcmula ; represents anti suggests ·that the •. ~ ~" prodi:ict.-Taises? "the .body's · protective . .~1• ~

. '"' , "" "-: ' ;,.

system .with perfectly .. balanced herbs and . pot.erit super foods· when a cold or ' flu fe

1els

iminent, when resistance is low; o'r whe·n one is at risk; that the product "insures against depletion of any of the critical .. deficiencies that may impair the work of -the body's protective system•; prevents ' zinc deficiencies which lead to weakened thymus glands and ·reduction in the body's

•'· "

:\ ,. (,"· 1'1.'\• [~ •

\ .,:~~~~ ,:..·' 't -~ '"'.( ,:~ .~,. J{ ,,

-~ .': ..,, . ·~· .

·~ . \ .. , ·"

•I,'

•

• 502(a)

502(f)(l)

• 505(a)

factors . i.n~ the immune system, and . normalizes ·the balance of prostaglandins and hormones;

which statements are false . and misleading or otherwise contrary to fact .. since the drugs are not adequate and effective ~or .~uch purposes.

l .....

Futher, the articles are. misbranded in that promotional literature, entitled "'nle Purity of Earthrise Spirulina", claims that "Earthrise Farms Spirulina meets all° curreiit·.USA Food .and Drug Administrat:fon guidelines "f()r ;spirulina • ·· • • , which statement is false arid~.misleading. .. . .. Misbranded in that th~ labeling for Imun-N-Sure Colds ~ Flu Season Protection Formula, Step Ahead PMS Nutritional Supplement Plus Spirulina, Super-Beta Beta Carotene and Anti-Oxidants With Spirulina & Herhs fails to bear adequate directions for use for the pur?oses for which the drugs are intended, and fiO such directions can be writ~en.

I~un-N-Sure Colds & Flu Season Protec tion Formula , Step Ahead PMS ~utritional Supplement Plus Spiculina, and Super-Beta Beta Carotene and

~. -'.~ .. -;:·:;>. • _:.i·," !! •. ,. .

•

, ..... ... \, .. .. ' '· I

I

• .

We request that your reply include:

{l) An estimate of the quantities of the drugs manufactured or received within the past twelve (12) months.

(2) An estimate of the size and frequency of shipments made by you in the past .twelve (12) months.

(3)

(4)

(5)

An estimate of the amounts of the drugs that ·are in 'inventory under your control and your' estimate of .. the' amounts .·1n-.: distribution channels .·outside .,.your-controf·~ · .... :

•,•; ,• ' \ .· ... : ...... .;\_<,~,:~: .. 1; .. ~ . :~ ..• ' ·' ~. '. .; :~\~~::~~ ... .. ·, ' The date of discontinuance ·: in: .~the· ;event :- that dtsconunued mark't!t1ng ,·these ·d~ . :.Pr.oducts.

yoti :·b~~e .)llread;":I; 'h· · '· I ' ' .,· !_· .'• ' ,.' "'. ,h - ' .' • • . '·';·~ ::'>- ·' ~·o: .. .,' ,'

Your intention with respect to the .. disposition of your inventories and outside stocks in trade channels.

. ·• ... ... .. , . .

•

.·

•

•

~ (: RonalCi K• Johnson : . . .~

District Director San Francisco District

.t " . -: .

•