[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16520-16522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0118]


Guidance for FDA Staff on Sampling or Detention Without Physical 
Examination of Decorative Contact Lenses (Import Alert 86-10); 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for FDA Staff 
on Sampling or Detention Without Physical Examination of Decorative 
Contact Lenses (Import Alert 86-10).'' The guidance document 
includes FDA's guidance to FDA district offices for sampling or 
detention without physical examination of plano (zero-powered or 
noncorrective) contact lenses intended solely to change the appearance 
of the normal eye in decorative fashion, when these products are 
presented for importation into the United States.

DATES: Submit written or electronic comments on the guidance by June 3, 
2003.

ADDRESSES: Submit written requests for single copies of the Import 
Alert 86-10, to the Division of Import Operations and Policy 
(HFC-170), Office of Regulatory Affairs, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed 
adhesive labels to assist that office in processing your request. You 
may fax your request to 301-594-0413. Submit written comments on this 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Thaddeus J. Poplawski, Division of 
Import Operations and Policy (HFC-170), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-6553.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has been receiving reports that certain commercial entities are 
planning to distribute or may already be distributing plano (zero-
powered or noncorrective) contact lenses intended solely to change the 
normal appearance of the eye in decorative fashion (decorative contact 
lenses). FDA understands that these products are intended to be 
distributed without a prescription, without fitting by a qualified eye 
care professional, and without ongoing professional supervision.
    FDA believes that, like other contact lenses, decorative contact 
lenses can cause a variety of eye injuries and conditions. Lens wear 
has been associated with corneal ulcer, for example, which can progress 
rapidly, leading to internal ocular infection if left untreated. 
Uncontrolled infection

[[Page 16521]]

can lead to corneal scarring, which can lead to vision impairment. In 
extreme cases, corneal ulcer can result in blindness and eye loss. 
Other risks include conjunctivitis; corneal edema; allergic reaction; 
abrasion from poor lens fit; and reduction in visual acuity, contrast 
sensitivity, and other visual functions, resulting in interference with 
driving and other activities.
    FDA believes that these risks cannot be sufficiently controlled 
unless: (1) The wearer obtains advice from an eye care professional; 
(2) the lenses are fitted by or under the supervision of such a 
professional; and (3) the wearer remains under appropriate professional 
supervision. Eye care professional involvement is legally required (21 
CFR 801.109) for contact lenses intended for medical purposes (i.e., 
prosthetic use or vision correction). These products are regulated by 
FDA as medical devices under the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 301 et seq.). \1\ Such control is not available 
for decorative contact lenses because these products are cosmetics 
under section 201(i) of the act (21 U.S.C. 321(i)).
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    \1\There are some lenses currently on the market under cleared 
510(k)s covering contact lenses intended for both vision correction 
use and for solely decorative purposes.The sponsors in these cases 
voluntarily included a plano lens in the range of corrective powers 
described in the 510(k) submissions.
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    Section 201(i) of the act defines ``cosmetic'' to include 
``articles intended to be rubbed, poured, sprinkled, or sprayed on, 
introduced into or otherwise applied to the human body or any part 
thereof for cleansing, beautifying, promoting attractiveness, or 
altering the appearance * * * '' (21 U.S.C. 321(i)(1)). Decorative 
contact lenses are articles intended to be introduced into the eye, 
which is a part of the body, to beautify the wearer, promote the 
attractiveness of the wearer, or alter the wearer's appearance. They 
are claimed to achieve this cosmetic result by changing the apparent 
color of the iris; by appearing to add a design to the iris (e.g., a 
professional sports team insignia); or by imparting a nonhuman or 
otherwise nonnormal appearance to the eye (e.g., cat's eye). Provided 
they are not marketed with claims\2\ that they effect physical or 
physiological change, decorative contact lenses are properly regulated 
as cosmetics under the act (cf. United States v. An Article * * * 
``Sudden Change,'' 409 F.2d 734 (2d Cir. 1969) (``claiming to affect 
the structure of the skin in some physiological way'' makes a product a 
``drug''); 21 CFR 700.35 (``sunscreen'' claims make a product a drug)).
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    \2\American Health Prods Co. v. Hayes, 574 F. Supp. 1498, 1505 
(S.D.N.Y. 1983), aff'd on other grounds, 744 F.2d 912 (2d Cir. 1984) 
(The courts ``have always read the * * * statuatory definitions 
employing the term `intended' to refer to specific marketing 
representations.'').
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    The fact that contact lenses are ``devices'' in the colloquial 
sense does not preclude cosmetic status under the act. FDA has 
previously determined that section 201(i) of the act applies to 
appearance-enhancing devices such as wigs, hair brushes, stockings and 
toothpicks (Refs. 1 through 3).
    Moreover, the fact that a product is intended to come into contact 
with the eye does not make it ineligible for cosmetic regulation (Ref. 
4). Indeed, the legislative history accompanying the original 1938 act 
demonstrates that Congress enacted the cosmetic adulteration provisions 
to address the risk to users presented by cosmetic products that may 
cause blindness and other serious injuries (S. Rept. 74-361 at 21 
(1935)).
    On October 22, 2002, FDA issued Import Alert 86-10, with 
respect to decorative contact lenses. We are now publishing a revised 
Import Alert 86-10 in the Federal Register. The Import Alert 
86-10 does not cover contact lenses that are intended for 
vision correction or for prosthetic or other medical use.
    Section 801(a) of the act (21 U.S.C. 381(a)) authorizes FDA to 
refuse admission to articles that appear to be adulterated or 
misbranded. Based on the available evidence, FDA believes that 
decorative contact lenses presented for importation may appear to be 
adulterated under section 601(a) of the act (21 U.S.C. 361(a)), in that 
they contain a deleterious substance that is dangerous to wearers of 
the lenses when they are put to a labeled, customary, or usual use. The 
deleterious substance is the matrix in which colorants are embedded. 
This material can cause the potentially vision-threatening eye 
conditions discussed previously, particularly if the wearer fails to 
obtain appropriate professional counseling, fitting, and ongoing 
supervision; if the wearer trades lenses, fails to use proper 
disinfection and other care techniques; or if the wearer wears lenses 
for longer than the recommended period. Consequently, FDA believes that 
decorative contact lenses appear to be adulterated under section 
601(a).
    Decorative contact lenses may also be subject to refusal if they 
appear to contain unsafe color additives (21 U.S.C. 381(a) and 361(e)). 
FDA understands that certain overseas manufacturers or distributors 
might have selected color additives for use in decorative contact 
lenses intended for U.S. distribution based on the fact that they have 
been approved by FDA for use in medical devices. To be used lawfully in 
decorative contact lenses, a color additive must be approved by FDA for 
use in eye area cosmetics. Not all color additives approved for use in 
medical devices have been approved for eye area use in cosmetics. 
Consequently, decorative contact lenses may also appear to be 
adulterated under section 601(e) of the act.
    Finally, decorative contact lenses may be subject to refusal on the 
ground that they are misbranded under section 602(a) of the act (21 
U.S.C. 362(a)) because their labeling is false or misleading ``in any 
particular.'' Under the act, labeling can be misleading by failing to 
disclose ``facts * * * material with respect to consequences which may 
result'' from use of a product under customary, usual, or labeled 
conditions (21 U.S.C. 321(n)). As noted previously, decorative contact 
lenses may cause serious health problems, including (in extreme cases) 
blindness. FDA believes these risks are material. If they are not 
disclosed in labeling, then the labeling would be misleading, and the 
product would appear to be misbranded under section 602(a) of the act 
and subject to refusal under section 801(a) of the act.

II. Guidance

    FDA's district offices may sample or detain without physical 
examination decorative contact lenses presented for U.S. importation.
    The Import Alert 86-10 applies to contact lenses that are: 
(1) Intended to change the appearance of the normal eye in decorative 
fashion; and (2) intended for distribution directly to the wearer, 
without the involvement of a qualified eye care professional. It does 
not cover contact lenses that are intended for vision correction or for 
prosthetic or other medical or therapeutic use and that are, therefore, 
properly regulated as medical devices under the act.

III. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on the sampling or detention without 
physical examination of decorative contact lenses that appear to be 
adulterated under section 601(a) and (e) of the act because they 
contain a deleterious substance that is harmful to users and/or contain 
an unapproved color additive, or appear to be misbranded under section 
602(a) because their labeling is false or misleading. It does not 
create or confer

[[Page 16522]]

any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the applicable statute and regulations.
    This guidance is effective immediately because prior public 
participation is not feasible or appropriate due to the risks to the 
public health presented by these products.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this guidance. Such 
comments will be considered when determining whether to amend the 
current guidance. Two paper copies of any mailed comments are to be 
submitted, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The guidance and received comments are 
available in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/ora/fiars/ora_import_ia8610.html.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Food and Drug Administration (FDA), Compliance Policy Guide 
(CPG) 7128.04 (revised August 1996) (hair brushes); (http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg590-400.htm).
    2. FDA, CPG 7128.05 (revised September 1, 1986) (wigs); (http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg590-600.htm).
    3. Hutt, Peter Barton, ``Reconciling the Legal, Medical, and 
Cosmetic Chemist Approach to the Definition of a `Cosmetic,' '' 
Cosmetic, Toiletry, and Fragrance Association Cosmetic Journal'', 
vol. 3, 1971 (excerpted in Peter Barton Hutt & Richard A. Merrill, 
Food and Drug Law: Cases and Materials, p. 824-825 (2d ed. 1991)).
    4. FDA, CPG 7128.03 (revised August 1996) (mascara is an eye-
contact cosmetic); (http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg590-300.htm).

    Dated: April 1, 2003.
John R. Marzilli,
Acting, Associate Commissioner for Regulatory Affairs.
[FR Doc. 03-8315 Filed 4-2-03; 11:42 am]
BILLING CODE 4160-01-S