Abbott Laboratories

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IN THE MATTER OF ABBOTT LABORATORIES CONSENT ORDER, ETC., INREGARD TO ALLEGED VIOLATION OF SECS. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-3745. Complaint, May 30, 1997--Decision, May 30, 1997 This consent order prohibits, among other things, the Illinois corporation that manufactures and advertises Ensure, a meal supplement, from making scientifically unsubstantiated claims about the extent to which doctors or other poatessrontls recommend any food dietary or nutritional supplement for ealthy adults; and about the recommendation, approval or endorsement of any such product by any person, profession or other entity. The consent order also prohibits the respondent from misrepresenting that one serving of any progact sold as a meal replacement or supplement, including Ensure, for ealthy adults provides vitamins in an amount comparable to typical vitamin pi str ae and from misrepresenting the amount of any vitamin or any other nutrient or ingredient in such products. Appearances For the Commission: Michelle Rusk, Michael Ostheimer and C. Lee Peeler.

For the respondent: Nancy Buc, Buc & Bearsdley, Washington, D.C.

COMPLAINT The Federal Trade Commission, having reason to believe that Abbott Laboratories, a corporation ("respondent"), has violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges: 1. Respondent Abbott Laboratories ("Abbott") is an Illinois corporation with its principal office or place of business at One Abbott Park Road, Abbott Park, Illinois. 2. Respondent has manufactured, advertised, labeled, offered for sale, sold, and distributed nutritional products to the public, including Ensure products. Ensure products are marketed through Abbott's Ross Products Division and include Ensure, Ensure High Protein, Ensure Plus, Ensure With Fiber, Ensure Pudding, and Ensure Light. These products are foods and/or drugs within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. 3. The acts and practices of respondent alleged in this complaint have been in or affecting commerce, as commerce is defined in Section 4 of the Federal Trade Commission Act. ABBOTT LABORATORIES 1379 1378 Complaint 4. Respondent has disseminated or has caused to be disseminated advertisements for Ensure, including but not necessarily limited to the attached Exhibits A through D. These advertisements contain the following statements and depictions:

A. VIDEO AUDIO Close-up of a graduation photograph Man: For 15 years, we've taken good of man and woman. care of each other.

Man and woman who appear to be in Woman: We sure have. their middle thirties. Man: And to take better care of our health, we started drinking Ensure.

Can of Ensure being poured into Woman: More than a vitamin glass. supplement, Ensure is a delicious drink with all the nutrients adults Man and woman jogging in a park. need to help stay healthy, active, be energetic.

Cans of Ensure. Super: Man: Drink Ensure as a meal. Woman: Or in between meals.

RECOMMENDED #1 BY DOCTORS. Man: Ensure is even recommended number one by doctors as a source of complete balanced nutrition.

Woman: Ensure, to your -health honey.

Man: Uh, uh, to our health.

(Exhibit A, television advertisement entitled Younger5 1 6 1 1 7 1475 1770 347 47 86.452003 Husband/Wife). B. VIDEO AUDIO Close-up of black and white Woman: When I was young, you photograph of little girl and young and mom made sure I ate right. father fishing.

Father and adult daughter fishing on Man: Well you were my little girl. dock. Woman: Well today we're listening to our doctors and taking better care of our health with Ensure.

Three cans of Ensure. Super: Man: Ensure is recommended RECOMMENDED #1 BY DOCTORS. number one by doctors as a source - of complete balanced nutrition.

Can of Ensure being poured into Woman: More than a vitamin glass. supplement, Ensure has all the nutrients adults need to help stay Father and daughter in boat with healthy, active, be energetic. father casting. Man: Drink Ensure as a meal. Three cans of Ensure. Super: Woman: Or in between meals. RECOMMENDED #1 BY DOCTORS. Ensure, to your health dad. Mother: Uh, uh, to our health.

Ensure, doctors recommend it number one.

(Exhibit B, television advertisement entitled Father/Daughter). Complaint 123 F.T.C.

C. Wife: Oh boy, that water felt great! Husband: Sure did. I always feel so good after a swim. Wife: For 15 years, we've shared a pretty active life. Husband: I've loved every minute.

Wife: And to help make sure we stay active, one thing we've done lately is to drink Ensure.

Husband: Hm Hmm. See, our doctor told us that a key to being energetic and in good health is good nutrition.

Wife: Right. And one way to help guarantee that you're getting the nutrition you need, is by drinking Ensure.

Husband: More than a vitamin supplement, Ensure is a delicious drink that provides complete balanced nutrition.

Wife: It's got the protein, carbohydrates, minerals and vitamins your body needs everyday to help you stay healthy, active, be energetic. Husband: Drink Ensure anytime.

Wife: I like it as a delicious meal.

Husband: I like it in between meals. Ensure is even recommended number one by doctors and nutritionists for complete balanced nutrition. Wife: So make sure the ones you love get the nutrition they need. Ensure. To your health, dear.

Husband: Uh, uh, to our health.

(Exhibit C, radio advertisement entitled Younger5 1 2 15 1 7 1480 1572 344 46 90.537666 Husband/Wife). D. Depiction: Snapshots of a young man and a young woman. Backs 1 2 16 1 13 1934 1629 89 36 96.717346 then5 1 2 16 1 14 2036 1640 58 25 96.744942 we4 1 2 16 2 0 449 1686 1566 75 -1 5 1 2 16 2 1 449 1692 189 48 96.869370 promised5 1 2 16 2 2 651 1697 39 31 96.438133 to5 1 2 16 2 3 705 1692 108 36 96.729591 makes 1 2 16 2 4 828 1692 61 36 96.244179 thes 1 2 16 2 5 904 1696 98 32 96.418686 most5 1 2 16 2 6 1016 1697 62 31 96.485596 outs 1 2 16 2 7 1092 1692 46 36 93.306252 of5 1 2 16 2 8 1145 1690 219 47 91.510887 life...today5 1 2 16 2 9 1376 1690 67 71 52.176544 we'5 1 2 16 2 10 1446 1701 39 24 81.785324 re5 1 2 16 2 11 1500 1688 177 48 96.649872 enjoying5 1 2 16 2 12 1693 1699 112 34 96.622528 every5 1 2 16 2 13 1818 1686 197 37 94.891953 moment. DRINK TO YOUR HEALTH WITH ENSURE.” Depiction: Man and woman who appear to be in their thirties holding glasses of Ensure. The #1 Doctor Recommended Source of Nutrition. Most doctors will tell you that a key to good health is good nutrition. But even if you've improved your diet by eating more lean meats, fruits and vegetables, you still may not be getting the balanced nutrition you need. So how can you help guarantee that you and the ones you love get the right nutrition? With Ensure and New Ensure High Protein. Ensure is more than a vitamin supplement. It's complete balanced nutrition in a delicious ready-to-serve drink that provides an excellent balance of protein, carbohydrate, vitamins, and minerals. In addition, New Ensure High Protein is low in cholesterol and low in saturated fat while being high in the nutrients you need everyday to help stay healthy, be energetic and more active. Drink your favorite Ensure anytime. Enjoy it as a healthy meal by itself or as a healthy between-meal snack. Ensure is even recommended #1 by doctors as a complete source of nutrition.

So make sure the ones you love get the right nutrition. Drink Ensure and drink to your health.

(Exhibit D, print advertisement).

5. Through the means described in paragraph four, respondent has represented, expressly or by implication, that many doctors recommend Ensure as a meal supplement and as a meal replacement for healthy adults, including those in their thirties and forties. ABBOTT LABORATORIES 1381 1378 Complaint 6. Through the means described in paragraph four, respondent has represented, expressly or by implication, that it possessed and relied upon a reasonable basis that substantiated the representation set forth in paragraph five, at the time the representation was made. 7. In truth and in fact, respondent did not possess and rely upon a reasonable basis that substantiated the representation set forth in paragraph five, at the time the representation was made. Among other reasons, a survey of doctors relied upon by respondent was not designed to elicit whether many doctors actually recommend Ensure as a meal supplement or meal replacement for healthy adults, as opposed to for adults who are ill or elderly and may have nutritional deficiencies. The survey merely asked doctors to assume that they would recommend a supplement for adults who were not ill, and then to select the brand they would most recommend. Therefore, the representation set forth in paragraph six was, and is, false or misleading.

8. Through the means described in paragraph four, respondent has represented, expressly or by implication, that one serving of Ensure provides vitamins in an amount comparable to typical multivitamin supplements. .

9. In truth and in fact, one serving of Ensure does not provide vitamins in an amount comparable to typical multivitamin supplements. While the typical multivitamin supplement provides at least 100% of the recommended daily intake (RDJ) of vitamins for which RDIs have been established, at the time the advertisements were first disseminated, one serving of Ensure provided 62% of the RDI of Vitamin C and between 12% and 26% of the RDIs of the other vitamins for which RDIs have been established. Ensure has been reformulated and currently one serving provides 50% of the RDI of Vitamin C and 25% of the RDIs of the other vitamins for which RDIs have been established. Therefore, the representation set forth in paragraph eight was, and is, false or misleading. 10. The acts and practices of respondent as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act. Complaint 123 F.T.C.

EXHIBIT A PRODUCT: ENSURE VITAMIN SUPPLEMENT 95-09482 KH TME: “LOW IN SATURATED FAT”

PROGRAM: WORLD NEWS TONIGHT 6/16/95 30 STATION: ABC (NEW YORK) 6:47PM (MUSIC) MAN: For 15 years, we've teken good care of other.

WOMAN: We sure have. MAN: And to take better care of . our health, Ensure is a delicious drink with all supplement the nutrients adults need to help stay healthy, MAN: Drink Ensure as a meal. | MAN: Ensure is even active, be energetic. WOMAN: Or in between meals. recommended RECOMMENDED *1 By Doctors number one by doctors as a source WOMAN: Ensure. To your health, ANNCR: Also try Ensure high of complete balanced nutrition. honey. MAN: Uh uh, to our health. protein. It's low in saturated fat. (MUSIC OUT) ALSO AVAILABLE IM COLOR VIDTO-TAPE CASSETTE Exhibit A-1 Wb babs TY euberen b cua bs of cxatared vopephend by @. it cesmnet bs responds be Metered wappled by Leck TV Leparts exzy be wved for I Solvers perp alt Wry ot be rprodocod, ald ov pllcty drow edo 1d ABBOTT LABORATORIES 1378 ; Complaint EXHIBIT A Video cassette of Younger Husband/Wife and Father/Daughter Ensure television advertisements :

PROFESSIONAL VIDEO CASSETTE T-120PR PROFESSIONAL GRADE Exhibit aA-2 Complaint 123 F.TC.

EXHIBIT B A PRODUCT: ENSURE VITAMIN SUPPLEMENT 95-10434 AH TILE: “FATHER & DAUGHTER”

PROGRAM: CBS EVENING NEWS 07/10/95 730 STATION: CBS (NEW YORK) 6:48PM FATHER: Wall you were my little iMUSIC) girl.

young, DAUGHTER: Well today wa're FATHER: Ensure ig recommended DAUGHTER: More than a Vitamin iistening to our doctor, and taking ber one by O asa Supplement better care of our health with of complate balanced nutrition. Ensure.

be energetic. FATHER: Drink DAUGHTER: or in between. ANNCR: Ensure. doctors Ensure as a meal-- Ensure. to vour hearth Dad. recommend it number one- FATHER:L& un. to cur nealth (MUSIC OUT) ALSO AVAILABLE IN COLOR VIDZO-TAPE CASSETTE Exhibit B-1 Whale Race TV Geoorn emmmrrart to Gibure Ihe exiUiory Of marei-aL \UBEREd DY mH Lone! De TRUER. fT Te wcrrress wweseea oy dodo TY Reger may pe vit “> We ING FEVETEMME OUrOOLEN SOY TOY NOT DE NESTZZ-UEZ =H OVOWLR SET OTL: CIA OF eAMEAE: ABBOTT LABORATORIES 1378 Complaint EXHIBIT B Video cassette of Younger Husband/Wife and | Father/Daughter Ensure television advertisements PROFESSIONAL VIDEO CASSETTE PROFESSIONAL GRADE Exhibit p-2 Complaint 123 F.T.C.

EXHIBIT C SCRIPT FOR kl RADIO 0 TELEVISION FROM LCF&L Date:

Chene:

Commercial title:

Version no:

Length:

WIFE:

HUSBAND:

WIFE:

HUS WIFE:

6/21/94 Ross Labs\Ensure “Younger Husband/Wife"

RLE-428-60 :60 (MUSIC & SFX UNDER) Oh, boy, that water felt great! Sure did. I always feel so good after a swim. For 15 years, we've shared a pretty. active life. I've loved every minute.

And to help make sure we stay active, one thing we've been doing lately is to drink ENSURE.

Hm Hmm. See, our doctor told us that a key to being energetic and in good health is good audition.

Right. And one way to help guarantee that you're getting the nutrition you need, is by drinking ENSURE.

More than a vitamin supplement, ENSURE isa delicious drink that provides complete balanced nutrition.

It's got the protein, carbohydrates, minerals and vitamins your body needs everyday to help you stay health, active, be energetic.

Exhibit C ABBOTT LABORATORIES WIFE:

Complaint EXHIBIT C Drink ENSURE anytime.

I like it as a delicious meal.

I like it in between meals. ENSURE is even recommended #1 by doctors and nutritionists for complete balanced autrition.

So make sure the ones you love get the nutrition they need. ENSURE. To your health, dear.

Uh, uh, to our health.

(SFX: CLINK) Use as directed.

Exhibit C Complaint 123 F.T.C.

EXHIBIT D “Back then we promised to make the most out of life...today we're enjoying every moment.” The #1 Doctor Recommended Source of Nutrition. Mos doctors will cell you that a key to good of protein, carbohydrate, vitamins and minerals. health is good nurnition. But even if you've improved —_ In addition, New Ensure High Protein is low in choyour diet by eating more lean meats, fruits and veg- lesterol and le-w in saturated far while being high in etables, vou stil] may not be getting the balanced the nutrients you need everyday to help stay healthy, be energetic and more active. Drink your favorite nucrition vou need.

Ensure anytime. Enjoy it as a healthy meal by itself So how can you help guarantee that you and the ones vou love ger the right nutrition? — _._= orasahealthy berween-meal snack. With Ensure and New Ensure ENSURE Ensure is even recommended #1 High Protein. -= by doctors as a complete source of Ensure ts more than a vitamin nutrition. lernenr, It's complere b | see So make sure che ones supple, complete. <_-_ ——— —= balanced nutrinion in a deli- pela “+= ---e——= vou love get the nght numnon. cious readv-to-serve drink that {NSURE ENSURE Dnnk Ensure and drink co provides an excellent balance aiid vour health. } Ne Exhibit D ™.

\wadable in 11 Deboour Flavors — — ee re ee ABBOTT LABORATORIES 1389 1378 Decision and Order DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices of the respondent named in the caption hereof, and the respondent having been furnished thereafter with a copy of a draft complaint which the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge respondent with violation of the Federal Trade Commission Act; and The respondent, its attorneys, and counsel for the Commission having thereafter executed an agreement containing a consent order, an admission by the respondent of all the jurisdictional facts set forth in the aforesaid draft complaint, a statement that the signing of the agreement is for settlement purposes only and does not constitute an admission by respondent that the law has been violated as alleged in such complaint, or that the facts as alleged in such complaint, other than jurisdictional facts, are true and waivers and other provisions as required by the Commission's Rules; and The Commission having thereafter considered the matter and having determined that it had reason to believe that the respondent has violated the Act, and that complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such agreement on the public record for a period of sixty (60) days, and having duly considered the comments received, now, in further conformity with the procedure prescribed in Section 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings, and enters the following order:

1. Respondent Abbott Laboratories is a corporation organized, existing and doing business under and by virtue of the laws of the State of Illinois with its principal office or place of business at One Abbott Park Road, Abbott Park, Illinois. 2. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondent, and the proceeding is in the public interest.

ORDER DEFINITIONS For purposes of this order, the following definitions shall apply: Decision and Order 123 F.T.C.

1. Unless otherwise specified, respondent shall mean Abbott Laboratories, a corporation, its successors and assigns, and its officers, agents, representatives and employees. 2. In5 1 3 2 1 3 705 618 53 27 96.981636 or5 1 3 2 1 4 772 602 209 57 96.091217 affecting5 1 3 2 1 5 995 602 270 44 96.539436 commerce shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. 44. I.

It is ordered, That respondent, directly or through any corporation, subsidiary, division or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Ensure products, any other food, or any other dietary or nutritional supplement in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, about: | A. The extent to which doctors or other professionals recommend such product for healthy adults; or B. The recommendation, approval, or endorsement of such product by any person, profession, group, or other entity, unless, at the time it is made, respondent possesses and relies upon competent and reliable evidence, which when appropriate must be competent and reliable scientific evidence, that substantiates the representation. For purposes of this order, competent5 1 7 1 4 8 1827 1999 85 44 96.688477 ands 1 7 1 4 9 1933 1998 181 44 96.602829 reliable4 1 7 1 5 0 470 2068 1647 59 -1 5 1 7 1 5 1 470 2074 219 44 96.335999 scientific5 1 7 1 5 2 710 2074 235 44 96.043846 evidence shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. Il.

It is further ordered, That respondent, directly or through any corporation, subsidiary, division or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Ensure products, or any other product advertised, marketed or sold as a meal replacement or meal supplement for healthy adults, in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication: ABBOTT LABORATORIES 1391 1378 Decision and Order A. That one serving of such product provides vitamins in an amount comparable to typical vitamin supplements; or B. The absolute or comparative amount of any vitamin or any other nutrient or ingredient contained in or provided by such product. If any representation covered by this Part either directly or by implication conveys any nutrient content claim defined (for purposes of labeling) by any regulation promulgated by the Food and Drug Administration, compliance with this Part shall be governed by the qualifying amount for such defined claim as set forth in that regulation.

Il.

Nothing in this order shall prohibit respondent from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.

IV.

It is further ordered, That respondent, and its successors and assigns, shall for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon request make available to the Federal Trade Commission for inspection and copying:

A. All advertisements and promotional materials containing the representation;

B. All materials that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in its possession or control that contradict, qualify, or call into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations.

V.

It is further ordered, That respondent, and its successors and assigns, shall:

Decision and Order 123 F.T.C.

A. Within thirty (30) days after the date of service of this order, deliver a copy of this order to all current principals, officers, directors, and managers, and to all current employees, agents, and representatives having responsibilities with respect to the subject matter of this order; and ) B. For a period of five (5) years after the date of service of this order, deliver a copy of this order to all future principals, officers, directors, and managers, and to all employees, agents, and representatives having responsibilities with respect to the subject matter of this order, within thirty (30) days after the person assumes such position or responsibilities.

VI.

It is further ordered, That respondent, and its successors and assigns, shall notify the Commission at least thirty (30) days prior to any change in the corporation(s) that may affect compliance obligations arising under this order, including but not limited to a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor corporation; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the corporate name or address. Provided, however, that, with respect to any proposed change in the corporation about which respondent learns less than thirty (30) days prior to the date such action is to take place, respondent shall notify the Commission as soon as is practicable after obtaining such knowledge. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, Washington, D.C. VU.

It is further ordered, That respondent, and its successors and assigns, shall, within sixty (60) days after the date of service of this order, and at such other times as the Federal Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which it has complied with this order. ABBOTT LABORATORIES 1393 1378 Decision and Order Vill.

This order will terminate on May 30, 2017, or twenty (20) years ~ from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of: A. Any Part in this order that terminates in less than twenty (20) years;

B. This order's application to any respondent that is not named as a defendant in such complaint; and C. This order if such complaint is filed after the order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that the respondent did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that the order will not terminate between the date such complaint 1s filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. Complaint 123 F.T.C.