2016 -- H 7915

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LC005333

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2016

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A N   A C T

RELATING TO FOOD AND DRUGS - RHODE ISLAND FOOD, DRUGS, AND COSMETICS

ACT

     

     Introduced By: Representatives Tobon, Kazarian, Barros, Abney, and Diaz

     Date Introduced: March 10, 2016

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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     SECTION 1. Section 21-31-2 of the General Laws in Chapter 21-31 entitled "Rhode

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Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:

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     21-31-2. Definitions. -- For the purpose of this chapter:

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      (1) "Advertisement" means all representations disseminated in any manner or by any

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means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly

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or indirectly, the purchase of food, drugs, devices, or cosmetics.

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      (2) "Contaminated with filth" applies to any food, drug, device, or cosmetic not securely

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protected from dust, dirt, and, as far as may be necessary by all reasonable means, from all

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foreign or injurious contaminations.

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      (3) "Cosmetics" means: (i) articles intended to be rubbed, poured, sprinkled, or sprayed

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on, introduced into, or applied to the humanbody human body or any part of the body for

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cleansing, beautifying, promoting attractiveness, or altering the appearance, and (ii) articles

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intended for use as a component of any articles described in this subdivision chapter, except that

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this term shall not include soap.

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      (4) "Device" (except when used in subdivision (23) of this section and in §§ 21-31-3(10),

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21-31-11(6), 21-31-15(a)(3), and 21-31-18(3)) means instruments, apparatus, and contrivances,

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including their components, parts, and accessories, intended: (i) for use in the diagnosis, cure,

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mitigation, treatment, or prevention of disease in humans or other animals; or (ii) to affect the

 

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structure or any function of the body of humans or other animals.

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      (5) "Director" means the director of health.

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      (6) "Distressed merchandise" means any food which has had the label lost or which has

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been subjected to possible damage due to accident, fire, flood, adverse weather, or to any other

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similar cause, and which may have been rendered unsafe or unsuitable for human or animal

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consumption or use.

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      (7) "Dosage form" means the form of the completed drug product (such as tablet, syrup,

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or suppository).

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      (8) "Drug" means: (i) articles recognized in the official United States Pharmacopoeia,

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official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any

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supplement to any of them; (ii) articles intended for use in the diagnosis, cure, mitigation,

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treatment, or prevention of disease in humans or other animals; (iii) articles (other than food)

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intended to affect the structure or any function of the body of humans or other animals; and (iv)

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articles intended for use as a component of any article specified in paragraphs (i), (ii) or (iii) of

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this subdivision; but does not include devices or their components, parts, or accessories.

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      (9) "Drug product" means a dosage form containing one or more active therapeutic

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ingredients along with other substances included during the manufacturing process.

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      (10) (i) "Equivalent and interchangeable" means having the same generic name, dosage

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form, and labeled potency, meeting standards of the United States Pharmacopoeia or National

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Formulary, or their successors, if applicable, and not found in violation of the requirements of the

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United States Food and Drug Administration, or its successor agency, or the department of health.

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      (ii) "Generic" means the chemical or established name of a drug or drug product.

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      (11) "Federal Act" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et

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seq.

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      (12)"Food" means: (i) articles used for food or drink for humans or other animals, (ii)

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chewing gum, and (iii) articles used for components of any article described in this subdivision.

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      (13) (i) "Label" means a display of written, printed, or graphic matter upon the

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immediate container of any article; and a requirement made by or under authority of this chapter

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that any word, statement, or other information appearing on the label shall not be considered to be

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complied with unless the word, statement, or other information also appears on the outside

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container or wrapper, if any, of the retail package of the article, or is easily legible through the

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outside container or wrapper.

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      (ii) "Immediate container" does not include package liners.

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      (iii) "Labeling" means all labels and other written, printed, or graphic matter: (A) upon

 

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an article or any of its containers or wrappers, or (B) accompanying the article.

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      (iv) If an article is alleged to be misbranded because the labeling is misleading, or if an

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advertisement is alleged to be false because it is misleading, then in determining whether the

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labeling or advertisement is misleading there shall be taken into account (among other things) not

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only representations made or suggested by statement, word, design, device, sound, or in any

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combination of them, but also the extent to which the labeling or advertisement fails to reveal

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facts material in the light of the representations or material with respect to consequences which

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may result from the use of the article to which the labeling or advertisement relates under the

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conditions of use prescribed in the labeling or advertisement or under the conditions of use that

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are customary or usual.

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      (14) "Native" means a product harvested in Rhode Island and is limited to the following:

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      (i) "Bay scallop" means Argopecten irradians.

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      (ii) "Bay quahog" means Mercenaria mercenaria.

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      (iii) "Steamer clams" means Mya arenaria.

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      (iv) "Mussels" means Mytilus edulis.

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      (v) "Oysters" means Crassostrea virginica.

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      (15) "New drug" means: (i) any drug the composition of which is such that the drug is

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not generally recognized among experts qualified by scientific training and experience to evaluate

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the safety of drugs as safe for use under conditions prescribed, recommended, or suggested in the

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labeling of it; or (ii) any drug the composition of which is such that the drug, as a result of

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investigations to determine its safety for use under those conditions has become so recognized,

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but which has not, otherwise than in the investigations, been used to a material extent or for a

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material time under those conditions.

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      (16) "Official compendium" means the official United States Pharmacopoeia, official

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Homeopathic Pharmacopoeia of the United States, official National Formulary, or any

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supplement to any of them.

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      (17) "Patient" means, as the case may be: (i) the individual medically requiring a drug,

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for whom a drug is prescribed; or (ii) the owner or the agent of the owner of an animal medically

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requiring a drug, for which a drug is prescribed.

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      (18) "Person" includes individual, partnership, corporation, and association.

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      (19) "Pharmacist" means a person duly registered with the board of pharmacy as a

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compounder, dispenser, or supplier of drugs upon prescription, including registered assistant

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pharmacists as defined by law.

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      (20) "Pharmacy" means a place where drugs, medicines, or poisons are sold at retail or

 

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where prescriptions of physicians, dentists, veterinarians, and other practitioners authorized to

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issue prescriptions for drugs, medicines, and poisons are compounded, dispensed, supplied or

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sold.

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      (21) "Practitioner" means a person authorized by law to practice medicine, dentistry,

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osteopathy, chiropody, or veterinary medicine in this state.

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      (22) "Prescription" means an order, issued in good faith in the course of professional

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practice only, by a practitioner to a pharmacist for a drug for a particular patient, which specifies

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the date of its issue, the name and address of the practitioner, the name and address of the patient

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(and, if the drug is prescribed for an animal, the species of the animal), the name and quantity of

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the drug prescribed, directions for the use of the drug, and the signature of the practitioner;

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provided, that a prescription received by word of mouth, telephone, or other means of

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communication shall be reduced promptly to writing by the pharmacist in the form prescribed in

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this subdivision, and the record so made shall constitute the original prescription to be filed and

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preserved by the pharmacist; and, provided, further, that any refill authorization received by word

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of mouth, telephone, or other means of communication shall be reduced promptly to writing by

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the pharmacist, with the date of it on the face or on the reverse side of the original prescription.

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      (23) The representation of a drug, in its labeling or advertisement, as an antiseptic shall

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be considered to be a representation that it is a germicide, except in the case of a drug purporting

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to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting

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powder, or any other use that involves prolonged contact with the body.

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      (24) The provisions of this chapter regarding the selling of food, drugs, devices, or

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cosmetics shall be considered to include the manufacture, production, processing, packing,

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exposure, offer, possession, and holding of any article for sale, and the sale, dispensing, and

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giving of any article, and the supplying or applying of the articles in the conduct of any food,

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drug, or cosmetic establishment.

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     SECTION 2. Chapter 21-31 of the General Laws entitled "Rhode Island Food, Drugs,

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and Cosmetics Act" is hereby amended by adding thereto the following section:

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     21-31-18.1. Cosmetic ingredient disclosure. -- (a) Beginning January 1, 2017, any

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cosmetic manufactured, distributed or offered for retail sale in this state shall disclose on the

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product label and on the manufacturer’s Internet website the full list of ingredients in the product,

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including the component ingredients of fragrances, flavors and color additives. The Chemical

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Abstract Service (CAS) number of each ingredient shall be included on the ingredient list

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provided on the manufacturer’s Internet website.

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     (b) The ingredients shall be listed in descending order of predominance, except that an

 

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ingredient present at a concentration of not more than one percent may be listed without respect

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to order of predominance.

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     (c) The manufacturer is not required to list the concentration of an ingredient in the

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product on the label or on the manufacturer’s Internet website.

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     (d) A cosmetic ingredient shall be identified in the declaration of ingredients in

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accordance with Part 701.3(c) of the Code of Federal Regulations, referred to as 21 CFR

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701.3(c).

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     (e) If any person violates any provision of this section, or any regulation adopted

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pursuant to this section, the director shall assess a fine of not less than ten thousand dollars

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($10,000) per violation. If such violation is not corrected within six (6) months of the initial

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violation, the manufacturer shall be fined not less than twenty-five thousand dollars ($25,000).

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     SECTION 3. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS - RHODE ISLAND FOOD, DRUGS, AND COSMETICS

ACT

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     This act would require manufacturers to fully disclose all ingredients of their cosmetics

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on their product label, as well as on their website. Failure to do so would result in a substantial

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fine.

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     This act would take effect upon passage.

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