Abbott Laboratories; Analysis to Aid Public Comment

Federal RegisterJan 15, 1997

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FEDERAL TRADE COMMISSION

[File No. 962-3069]

Abbott Laboratories; Analysis to Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: In settlement of alleged violations of Federal law prohibiting

unfair or deceptive acts or practices and unfair methods of

competition, this consent agreement, accepted subject to final

Commission approval, would prohibit, among other things, the Abbott

Park, Illinois-based marketer of nutritional beverages from making any

claim about the extent to which doctors or other professionals

recommend any food or dietary or nutritional supplement, or about any

other recommendation, approval, or endorsement of such products, unless

it possesses competent and reliable scientific evidence to substantiate

the claim. The agreement settles allegations that Abbott made false and

unsubstantiated claims in an extensive national advertising campaign

that promotes the company's Ensure nutritional beverages for healthy,

active adults.

DATES: Comments must be received on or before March 17, 1997.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,

Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Michelle K. Rusk, Federal Trade Commission, S-466, 6th and Pennsylvania

Ave., NW., Washington, DC 20580. (202) 326-3148. Joel Winston, Federal

Trade Commission, S-4002, 6th and Pennsylvania Ave., NW., Washington,

DC 20580. (202) 326-3153.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal

Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46, and Section 2.34 of

the Commission's Rules of Practice (16 CFR 2.34) notice is hereby given

that the above-captioned consent agreement containing a consent order

to cease and desist, having been filed with and accepted, subject to

final approval, by the Commission, has been placed on the public record

for a period of sixty (60) days. The following Analysis to Aid Public

Comment describes the terms of the consent agreement, and the

allegations in the accompanying complaint. An electronic copy of the

full text of the consent agreement package can be obtained from the

Commission Actions section of the FTC Home Page (for January 2, 1997),

on the World Wide Web, at ``http://www.ftc.gov/os/actions/htm.'' A

paper copy can be obtained from the FTC Public Reference Room, Room H-

130, Sixth Street and Pennsylvania Avenue, NW., Washington, DC 20580,

either in person or by calling (202) 326-3627. Public comment is

invited. Such comments or views will be considered by the Commission

and will be available for inspection and copying at its principal

office in accordance with Section 4.9(b)(6)(ii) of the Commission's

Rules of Practice (16 FR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

The Federal Trade Commission has accepted an agreement to a

proposed consent order from Abbott Laboratories. This matter concerns

advertising for Ensure nutritional products.

The proposed consent order has been placed on the public record for

sixty (60) days for reception of comments by interested persons.

Comments received during this period will become part of the public

record. After sixty days, the Commission will again review the

agreement and the comments received and will decide whether it should

withdraw from the agreement or make final the agreement's proposed

order.

Ensure is a canned beverage which contains carbohydrates, protein,

fat, vitamins and minerals and is formulated so that the very elderly

and others who have difficulty obtaining sufficient nutrition from

regular food can subsist on it, for example through tube feeding. The

Ensure product line includes not only Ensure, but also Ensure High

Protein, Ensure Plus, Ensure With Fiber, Ensure Pudding, and Ensure

Light.

According to the Commission's complaint, Abbott advertisements made

the unsubstantiated representation that many doctors recommend Ensure

as a meal supplement and replacement for healthy adults, including

those in their thirties and forties. The complaint explains that, among

other reasons, this claim is unsubstantiated because a survey of

doctors relied upon by Abbott was not designed to elicit whether many

doctors actually recommend Ensure as a meal supplement or replacement

for healthy adults--as opposed to adults who are ill or elderly and may

have nutritional deficiencies. According to the complaint, 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.

The complaint also alleges that Abbott misrepresented that one

serving of Ensure provides vitamins in an amount comparable to typical

multivitamin supplements. According to the complaint, while the typical

multivitamin supplement provides at least 100% of the recommended daily

intake (RDI) of vitamins, at the time the advertisements challenged in

the complaint 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. The complaint

states that, although Ensure has been reformulated, one serving still

provides only 50% of the RDI of Vitamin C and 25% of the RDIs of the

other vitamins.

The proposed consent order contains provisions designed to remedy

the violations charged and to prevent Abbott from engaging in similar

acts and practices in the future.

Part I of the order requires Abbott not to make any claim about the

extent to which doctors or other professionals recommend any food or

dietary or nutritional supplement for healthy adults, or about the

recommendation, approval, or endorsement of such products by anyone,

unless it possesses

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competent and reliable evidence, which when appropriate must be

competent and reliable scientific evidence, that substantiates the

claim.

Part II prohibits Abott from misrepresenting that one serving of

any Ensure product, or any other product advertised, marketed or sold

as a meal replacement or supplement for healthy adults, provides

vitamins in an amount comparable to typical vitamin supplements. It

also prohibits Abbott from misrepresenting the absolute or comparative

amount of any vitamin or any other nutrient or ingredient provided by

such products. Part II also requires that any representation covered by

that Part that conveys a nutrient content claim defined for labeling by

any regulation of the Food and Drug Administration (``FDA'') must

comply with the qualifying amount set forth in that regulation.

Part III provides that representations that would be specifically

permitted in food labeling, under regulations issued by the FDA

pursuant to the Nutrition Labeling and Education Act of 1990, are not

prohibited by the order.

The proposed order also requires Abbott to maintain materials

relied upon to substantiate the claims covered by the order, to

distribute copies of the order to certain current and future officers

and employees, to notify the Commission of any changes in corporate

structure that might affect compliance with the order, and to file one

or more reports detailing compliance with the order. The order also

contains a provision stating that it will terminate after twenty (20)

years absent the filing in federal court, by either the United States

or the FTC, of a complaint against Abbott alleging a violation of the

order.

The purpose of this analysis is to facilitate public comment on the

proposed order, and it is not intended to constitute an official

interpretation of the agreement and proposed order, or to modify any of

their terms.

Donald S. Clark,

Secretary,

[FR Doc. 97-922 Filed 1-14-97; 8:45 am]

BILLING CODE 6750-01-M

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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