Tea may fit under the definition of a dietary supplement in two ways. Herbal tea is likely to be a dietary supplement because it is ¡°an herb or other botanical.¡± Traditional tea may qualify as a dietary supplement, though much less often, if it is sold in extract form or intended to supplement the diet and labeled as such, as is more often now being done with green tea. Dietary supplement manufacturers may only make structure/function claims, not disease claims, without FDA approval. They must also notify the FDA of the content of their structure/function claim within 30 days of marketing it.
When tea is seen as a dietary supplement, the manufacturers are more likely to get into trouble for their health-related claims. First, they make take their structure/function claims too far and end up making a disease claim, which qualifies the tea as a drug. Second, they may believe that their tea is a food and therefore fail to comply with the labeling and disclaimer requirements for dietary supplements. Third, they may fail to notify the FDA of their structure/function claim if they believe their tea only qualifies as a food and not as a dietary supplement under the FDCA. Finally, they may fail to comply with the conditions regarding third-party literature under the DSHEA and risk being considered misbranded.
Many herbal products are clearly dietary supplements and are properly labeled as such. These products tend to run into problems when their marketing involves dissemination of scientific literature and they make the connection between the herb and a disease. At this point they are walking a fine line between dietary supplement and drug. Dietary supplement manufacturers are also torn in some ways between the FDA and the FTC. The DSHEA allows them to use third-party literature in connection with their marketing, as long as it is not false or misleading and is well balanced, while the FTC Act requires that the health claims be substantiated. Manufacturers may be tempted to let the third-party literature do too much marketing while ignoring the requirements in the FTC Act. |
