Guidelines for Unsolicited Consumer Sampling of Nonprescription Medicines

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1967, 1969, 1994, 1995, 2015

Many members of the Consumer Healthcare Products Association (CHPA) provide unsolicited free samples of nonprescription, over-the-counter (OTC) medicines to consumers through the mail or by other means to promote their products. This is an economical and efficient way to accomplish mass sampling. It has been successfully followed for many years, and accidental ingestion of sample OTC medicines by children has been kept to a minimum.

The purpose of these guidelines, adopted for bulk mail sampling in 1967, amended in 1968 and 1969, and further amended in 1994, 1995 and 2015 to include other means of unsolicited consumer sampling, is to catalogue and strengthen standards of care which have evolved in this practice. While these guidelines may be employed in other forms of product promotion, they are not intended to cover transactions in which samples are provided in response to requests from consumers, are delivered to adult consumers in person or are mailed to professionals, such as physicians or dentists, at their office addresses. The company should require that a non-covered transaction, whether carried out by the company itself or by a third party, is conducted in a manner that minimizes potential risk to a child, and is not conducted in such a way that it becomes subject to the guidelines and is not in conformance with them.

These guidelines, carefully observed by the industry, should help guarantee the continued safety and success of this marketing practice. The guidelines read as follows:

  1. Child-resistant packaging should be used when required either by regulation or additionally via an internal company safety assessment.
  2. The total amount of the product supplied in any one sample should not be great enough to cause bodily injury to a child if ingested.
  3. Where there is an objective safety concern such that ingestion of multiple samples thereof represents a reasonable hazard to a small child, the inner and/or outer container should be of such design, either through strength of closures or other methods, to inhibit accidental ingestion by a small child.
  4. The outer container of every sample (such as the envelope or other package that the consumer receives in the mail or by other means) should be clearly and conspicuously labeled to show that it contains a medicinal product, and should avoid use of designs or pictures with cartoons or other juvenile themes that could encourage children to open it.
  5. Multiple dwellings should not be included in samplings when such sampling would present a reasonable hazard to a small child.
  6. Members of the packaging industry should be consulted periodically to ensure the latest advances in the art of safe packaging are utilized in sampling.
  7. The company should also require that each of the guidelines is followed when the sampling has been contracted to a third party, rather than done by the company itself.