[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.319]
[Page 85-86]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic
mucilloids (including, but not limited to agar, alginic acid, calcium
polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus,
glucomannan ((B-1,4 linked) polymannose acetate), guar gum,
karaya gum, kelp, methylcellulose, plantago seed (psyllium),
polycarbophil tragacanth, and xanthan gum) as active
ingredients; required warnings and directions.
(a) Reports in the medical literature and data accumulated by the
Food and Drug Administration indicate that esophageal obstruction and
asphyxiation have been associated with the ingestion of water-soluble
gums, hydrophilic gums, and hydrophilic mucilloids including, but not
limited to, agar, alginic acid, calcium polycarbophil,
carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-
1,4 linked) polymannose acetate), guar gum, karaya gum, kelp,
methylcellulose, plantago seed (psyllium), polycarbophil, tragacanth,
and xanthan gum. Esophageal obstruction and asphyxiation due to orally-
administered drug products containing water-soluble gums, hydrophilic
gums, and hydrophylic mucilloids as active ingredients are significant
health risks when these products are taken without adequate fluid or
when they are used by individuals with esophageal narrowing or
dysfunction, or with difficulty in swallowing. Additional labeling is
needed for the safe and effective use of any OTC drug product for human
use containing a water-soluble gum, hydrophilic gum, or hydrophilic
mucilloid as an active ingredient when marketed in a dry or incompletely
hydrated form to include, but not limited to, the following dosage
forms: capsules, granules, powders, tablets, and wafers.
(b) Any drug products for human use containing a water-soluble gum,
hydrophilic gum, or hydrophilic mucilloid as an active ingredient in an
oral dosage form when marketed in a dry or incompletely hydrated form as
described in paragraph (a) of this section are misbranded within the
meaning of section
[[Page 86]]
502 of the Federal Food, Drug, and Cosmetic Act unless their labeling
bears the following warnings (under the subheading ``Choking'') and
directions:
`` `Choking' [highlighted in bold type]: Taking this product without
adequate fluid may cause it to swell and block your throat or esophagus
and may cause choking. Do not take this product if you have difficulty
in swallowing. If you experience chest pain, vomiting, or difficulty in
swallowing or breathing after taking this product, seek immediate
medical attention;'' and
`` `Directions' [highlighted in bold type]:'' (Select one of the
following, as appropriate: ``Take'' or ``Mix'') ``this product (child or
adult dose) with at least 8 ounces (a full glass) of water or other
fluid. Taking this product without enough liquid may cause choking. See
choking warning.''
(c) After February 28, 1994, any such OTC drug product initially
introduced or initially delivered for introduction into interstate
commerce, or any such drug product that is repackaged or relabeled after
this date regardless of the date the product was manufactured, initially
introduced, or initially delivered for introduction into interstate
commerce, that is not in compliance with this section is subject to
regulatory action.
[58 FR 45201, Aug. 26, 1993, as amended at 64 FR 13292, Mar. 17, 1999]
Effective Date Note: At 72 FR 14674, Mar. 29, 2007, Sec. 201.319
was amended by revising paragraph (a), effective Oct. 1, 2007. For the
convenience of the user, the revised text is set forth as follows:
[Page 86]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic
mucilloids (including, but not limited to agar, alginic acid,
calcium polycarbophil, carboxymethylcellulose sodium,
carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose
acetate), guar gum, karaya gum, kelp, methylcellulose,
plantago seed (psyllium), polycarbophil, tragacanth, and
xanthan gum) as active ingredients; required warnings and
directions.
(a) Reports in the medical literature and data accumulated by the
Food and Drug Administration indicate that esophageal obstruction and
asphyxiation have been associated with the ingestion of water-soluble
gums, hydrophilic gums, and hydrophilic mucilloids including, but not
limited to, agar, alginic acid, calcium polycarbophil,
carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-
1,4 linked) polymannose acetate), guar gum, karaya gum, kelp,
methylcellulose, plantago seed (psyllium), polycarbophil, tragacanth,
and xanthan gum. Esophageal obstruction and asphyxiation due to orally-
administered drug products containing water-soluble gums, hydrophilic
gums, and hydrophilic mucilloids as active ingredients are significant
health risks when these products are taken without adequate fluid or
when they are used by individuals with esophageal narrowing or
dysfunction, or with difficulty in swallowing. Additional labeling is
needed for the safe and effective use of any OTC drug product for human
use containing a water-soluble gum, hydrophilic gum, or hydrophilic
mucilloid as an active ingredient when marketed in a dry or incompletely
hydrated form to include, but not limited to, the following dosage
forms: Capsules, granules, powders, tablets, and wafers. Granular dosage
forms containing psyllium are not generally recognized as safe and
effective as OTC laxatives (see Sec. 310.545(a)(12)(i)(B) of this
chapter) and may not be marketed without an approved new drug
application because the warnings and directions in paragraph (b) of this
section have been found inadequate for these products.
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