FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

8. A comment disagreed with the requirements of 1040.20(d)(l)(vi) and (2) of the proposed amendments, arguing that there are not any lamps that are "uniquely designed" for a particular sunlamp product. According to the comment, only a few manufacturers of lamps manufacture replacement lamps for other manufacturers’ sunlamp products. The comment stated that FDA is providing an unfair competitive advantage to certain manufacturers and a great disadvantage to others because the additional labeling would be extremely expensive, in monetary as well as person-hour terms. The comment said that the requirement would have a significant impact on a substantial number of small entities, as this term is used in the Regulatory Flexibility Act. The comment stated further that it would be impossible for some manufacturers to maintain and service their own products because their products are distributed throughout the country and urged the agency not to exempt any sunlamp products or ultraviolet lamps from the proposed labeling requirements. According to the comment, there would be no way for FDA to monitor whether a particular unit was being maintained and serviced by the manufacturer or its agent.

After having reviewed reports submitted to the agency under Part 1002 (21 CFR Part 1002), FDA agrees that there are few ultraviolet lamps that are unique to a sunlamp product. The agency concludes that a substitute lamp could be made by other manufacturers. Also, FDA agrees that monitoring the maintenance and servicing of sunlamp products would be difficult and would not be warranted. For these reasons, FDA has concluded not to exempt any sunlamp products or ultraviolet lamps from the labeling requirements and has revised final 1040.20(d) (l)(vi) and (2) accordingly.

The comment does, however, illustrate that manufacturers use lamps produced by other firms. It also is apparent that many of these lamps are equivalent and can be used safely in a number of different models of sunlamp products. The current standard is not clear on how a person or manufacturer would be able to determine that a replacement lamp is equivalent to that designated on the sunlamp product to be used in the product. FDA advises that replacement lamps must comply with each applicable requirement of the performance standard and be certified under 1010.2 of the regulations (21 CFR 1010.2). Section 1040.20(e) requires that any ultraviolet lamp not accompanying a sunlamp product contain instructions for its safe use. Thus, the manufacturer of a replacement ultraviolet lamp is required to state in the user instructions any specific model of ultraviolet lamps for which the manufacturer is promoting its lamp as a replacement. FDA has revised 1040.20(e)(2) in the final rule to make this concept clear. FDA advises that the promotion of incompatible lamps will be considered as marketing a falsely certified product.

The final rule became effective Sept. 8, 1986, for sunlamp products and ultraviolet lamps that are manufactured on or after this date. Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before Sept. 8, 1986, are subject to the provisions of 21 CFR 1040.20 as published in the Federal Register of Nov. 9, 1979 (44 FR 65357). The agency, however, does not object to any manufacturer of a sunlamp product or ultraviolet lamp complying with the final rule after it is published and prior to its effective date, provided the manufacturer specifies on the certification label for the product that it complies with the amended standard and provided the manufacturer complies with the recordkeeping and reporting requirements of Part 1002.