METRIC LABELING FINAL RULE ENFORCEMENT DELAY REQUESTED BY NDMA

METRIC LABELING FINAL RULE ENFORCEMENT DELAY REQUESTED BY NDMA until nonconforming labels printed before the effective date of the regulation are no longer in circulation. In Feb. 22 comments to FDA, the Nonprescription Drug Manufacturers Association asked the agency to "clarify that the effective date of the regulation shall be no sooner than 30 days after publication of a final rule and that nonconforming labels printed until such date may continue to be used until stocks are depleted."

NDMA's comments are in response to FDA's Dec. 21 proposed rule on metric labeling, which would implement 1992 amendments to the Fair Packaging and Labeling Act (FPLA) ("The Tan Sheet" Jan. 3, p. 21). The proposal requires the use of both the International System of Units (SI or metric) and the inch-pound system for the declaration of net quantity of contents on the labeling of OTC drugs and other FDA-regulated products.

The proposal states that the final rule will go into effect 30 days after it is published in the Federal Register. However, the proposal also says that the amendments to the FPLA "have no effect on the sale or distribution of products whose labels were printed before February 14, 1994," which is the statutory effective date of the amendments. NDMA said this provision has caused some confusion because the requirements of the final rule had not been established by the statutory effective date.

"It is unclear what the 'real' effective date is," NDMA said. "That is, may companies use non-conforming labeling printed until 30 days after publication of a final rule, or only such labeling printed before Feb. 14, 19947 As a legal and practical matter, we maintain that the effective date cannot be Feb. 14, 1994, but may be no sooner than 30 days after publication of the final rule."

NDMA asserted that the delay in FDA's publication of the proposal has not given industry "sufficient lead time to plan for orderly label changes." The association suggested that "even if companies print and use dual metric-inch/pound labeling after Feb. 14, it may not technically comply with FDA regulations" since those final requirements will not be known "until FDA publishes a final rule."

The metric labeling proposal, NDMA pointed out, says that compliance with the final rule will not be monitored by FDA until after Nov. 8, 1994. However, the association maintained that "this problem is not cured by FDA's statement...since there may be non-conforming labeling printed after February 14 on the market after November 8, 1994." NDMA advised that "the February 14, 1994 effective date of the FPLA amendments can reasonably be read to refer to FDA's obligations to promulgate implementing regulations, rather than to industry's requirement to adopt dual inch/pound metric labeling."

In separate Feb. 22 comments, the Cosmetic, Toiletry and Fragrance Association also urged clarification of the effective date. However, CTFA recommended that FDA set the effective date at "no earlier than 90 days after publication of a final rule... and that labels printed prior to the effective date may be used until stocks are depleted."

NDMA requested that the final rule state clearly that companies are allowed to use their discretion to place either the metric or the inch/pound declaration first in the net quantity of contents statement.

Although the proposed reg permits either the metric or inch/pound declaration to appear first in the net quantity statement, NDMA said that the wording of the preamble has left some of the association's members with the impression that the metric quantity should appear first.

Procter & Gamble said in Feb. 18 comments to FDA that it "strongly endorses formal recognition of a system that would give manufacturers the choice to label all products containing one pound or more in either: (1) pounds; (2) ounces; or (3) both pounds and ounces located immediately adjacent to one another." The company also said it supports analogous declarations for liquids containing one pint or more to permit listing by either: (1) fluid ounces; (2) pints, quarts, or gallons; or (3) fluid ounces and pints, quarts, gallons located immediately adjacent to each other.

P&G said it believes "this system should extend beyond current maximums of four pounds and one gallon in order to afford all manufacturers with the ability to label all sizes of a marketed product (or brand name) in the same English unit -- "whether it be ounces, pounds, fluid ounces, or gallons."

However, "if FDA judges this approach to be too unrestrictive, then we strongly recommend formal recognition of voluntary dual English unit net content declarations for all products containing one or more pounds and one or more pints."

The company pointed out that its position is "based on providing the consumer with the best means of making price comparisons between different sizes of the same products and value comparisons between similar products." The same rationale "holds true for products containing more than four pounds and one gallon." The company noted that with the advent of club stores and "value-demanding consumers," manufacturers like P&G are making larger-sized products or multi-packs that extend product sizes above four pounds or one gallon.

In its proposal, FDA said that "there is good and sufficient reason to exempt certain commodities from the requirement that the customary inch-pound portion of the quantity of contents statement be expressed in pounds or the largest whole fluid unit."

Under this approach, "FDA will permit products that were previously required to bear a declaration in ounces or fluid ounces to bear such a declaration in place of a declaration in terms of pounds, quarts or pints," the agency explained. The proposal states that if "comments support such a finding, the agency will insert into the regulations provisions permitting the use of ounces or fluid ounces, instead of pounds, quarts, or pints, on packages that contain less than four pounds or less than one gallon."