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Recent Changes in US Regulations
By: David C. Steinberg, Steinberg & Associates
Posted: January 30, 2009, from the February 2009 issue of Cosmetics & Toiletries.
page 6 of 6
Companies may list means for consumers to contact them to report such adverse reactions either outside the Drug Facts box, or preferably under the Other information heading within the Drug Facts panel. One option is to list a telephone number but this must be answered by an individual and not electronically. This is because companies really should have written documentation if a true serious advent has occurred. The second and preferred option is to list a US-based address. This address can and probably should be a separate address from what is listed as required by the Fair Packaging and Labeling Act.
Upon being notified of an adverse reaction as defined by the FDA, companies are required to file specified information to the FDA within a limited time frame. However, since this is a very short time frame, sending a notice to a general address likely will not allow companies sufficient time to report. The FDA has issued a guidance document regarding this notification procedure and time frame, which can be found at: www.fda.gov/cder/guidance/7950dft.htm.
Although it is a good idea for consumers to have a way to report serious adverse events, most of the time, when a serious adverse event is occurring, there is only enough time to seek immediate medical care; letters and phone calls come later. This notification procedure is useful in the case of drug overdosage or reactions to drug ingestion. However, for cosmetic-like drugs such as topical OTC drugs that do not have dose restrictions or that can make cosmetic claims, requiring this contact information is just more label clutter. Even worse, some NGOs think the same information should be required on cosmetic labels. For foreign-based companies, this is difficult; and for US-based companies, it may be easier to outsource these address and reporting requirements.
Send e-mail to email@example.com.
1. BI Knight, Under Secretary for Marketing and Regulatory Programs, Sixth New Zealand Biosecurity Summit, Christchurch, New Zealand (Nov 4, 2008)
2. BI Knight, California Marine Affairs and Navigation Conference, Eureka, CA USA (Oct 15, 2008)
3. Ibid Ref 2