The Food and Drug Administration (FDA) has issued warnings to five individual e-cigarette distributors, stating that it intends to regulate electronic cigarettes and related products, since they are considered both a drug and a device under federal law. The FDA indicated that the distributors committed violations of the Food, Drug, and Cosmetic Act due to unsubstantiated claims and poor manufacturing practices. The FDA described that it intends to regulate electronic cigarettes as it does other potentially dangerous products to protect the public health.
With products encountering consumers at extremely high rates, consumers depend on the FDA to regulate potentially dangerous and unsafe products. In recent past, product liability lawsuits have filled in the gaps where the FDA was unable to regulate. Here, for e-cigarette distributors, the regulation is governed by the New Drug Application process. The New Drug Application process is the means in which drug sponsors formally propose that the FDA approve a new pharmaceutical drug product for sale and marketing in the United States. Prior to filing an New Drug Application, applicant firms submit to the FDA an Investigation New Drug application, in order to legally gather information on investigational products during animal and human clinical trials.
What happens, though, when a manufacturer fails to file such an application? For an example of what happens with the lack of regulating, look to the dietary supplements. By law, the manufacturer itself is responsible for ensuring the safety of a dietary supplement before it is marketing. Unlike drug products like the e-cigarettes that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to approve dietary supplements for safety or effectiveness before they reach the consumer. It is situations like these where injured plaintiffs may seek the assistance of a product liability lawyers like the attorneys at Levin & Perconti. Product liability lawsuits help to hold manufacturers of dangerous products accountable.
Follow the link to the FDA website to read the product warning letter.