To amend the Federal Food, Drug, and Cosmetic Act to require food and drug manufacturers to maintain a toll-free telephone line for inquiries respecting foods containing vitamins or minerals, herbal foods, foods for special dietary uses and over-the-counter drugs and to require the labels and advertising of such products to contain a reference to such line.

Amends the Federal Food, Drug, and Cosmetic Act to declare a food which contains vitamins or minerals, an herbal food, or a food which is for special dietary use or otherwise makes a health or nutrition claim to be misbranded, unless its label and advertising includes a listing of a toll-free telephone line maintained by its manufacturer to provide information respecting its ingredients.

Declares a drug which is not subject to certain exemptions misbranded unless its labeling and advertising includes a reference to a toll-free telephone line maintained by its manufacturer to provide information on the drug.

 
HR 509 IH
102d CONGRESS
1st Session
 H. R. 509
To amend the Federal Food, Drug, and Cosmetic Act to require food and
drug manufacturers to maintain a toll-free telephone line for inquiries
respecting foods containing vitamins or minerals, herbal foods, foods for
special dietary uses and over-the-counter drugs and to require the labels
and advertising of such products to contain a reference to such line.
IN THE HOUSE OF REPRESENTATIVES
January 11, 1991
Mr. KOLTER introduced the following bill; which was referred to the Committee
on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require food and
drug manufacturers to maintain a toll-free telephone line for inquiries
respecting foods containing vitamins or minerals, herbal foods, foods for
special dietary uses and over-the-counter drugs and to require the labels
and advertising of such products to contain a reference to such line.
  Be it enacted by the Senate and House of Representatives of the United
  States of America in Congress assembled,
SECTION 1. INFORMATION ON FOODS.
  Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343)
  is amended by adding at the end the following:
  `(r)(1) If it is a food which contains vitamins or minerals, a herbal food,
  or a food which is for special dietary use or otherwise makes a health or
  nutrition claim unless the label and advertising for such food includes,
  in accordance with regulations of the Secretary, a listing of the toll-free
  telephone line maintained by the manufacturer of such food to provide
  information respecting the ingredients of such food.
  `(2) The Secretary shall promulgate regulations prescribing--
  `(A) the manner in which manufacturers shall maintain a toll-free telephone
  line--
  `(i) for inquiries respecting food which contains vitamins or minerals,
  a herbal food, or a food which is for special dietary use or otherwise
  makes a health or nutrition claim, and
  `(ii) to provide for such food the information required by this section
  to be placed on its label, and
  `(B) the manner in which the manufacturers shall publicize the availability
  of the line in the labeling and advertising of such food.
Such regulations shall require that in advertising through television the
availability of the line shall be announced orally and also in bold face
type for at least 4 seconds and shall require that in print advertising and
in the food labels the availability shall include the following statement:
`Information about the ingredients of this product is available by calling:
1-800-(the manufacturer's toll-free line number).'.
SEC. 2. INFORMATION ON DRUGS.
  Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352)
  is amended by adding at the end the following:
  `(u)(1) If it is a drug which is not subject to section 503(b) unless
  the labeling and advertising for the drug includes, in accordance with
  regulations of the Secretary, a reference to the toll-free telephone
  line maintained by the manufacturer of the drug to provide information on
  the drug.
  `(2) The Secretary shall promulgate regulations prescribing--
  `(A) the manner in which manufacturers shall maintain a toll-free telephone
  line--
  `(i) for inquiries respecting drugs which are not subject to section
  503(b), and
  `(ii) to provide for such drugs the information required by this section
  to be placed on their labels, and
  `(B) the manner in which the manufacturers shall publicize the availability
  of the line in the labeling and advertising of such drug.'.
Such regulations shall require that in advertising through television the
availability of the line shall be announced orally and also in bold face
type for at least 4 seconds and shall require that in print advertising and
in the drug labels the availability shall include the following statement:
`Information about the ingredients of this product is available by calling:
1-800-(the manufacturer's toll-free line number).'.