Dietary supplements certainly seem to be in the news these days – and even more so when a well-known TV personality testifies before Congress. Senator Claire McCaskill, chairwoman of the subcommittee on Consumer Protection, Product Safety and Insurance recently led a hearing that was convened to examine the false advertising claims made for weight loss products, some of which were promoted on “The Dr. Oz Show”. Much has been written about the testimony and, as a result, the dietary supplement industry is coming under heavy criticism.
Is the industry too lax? Is more regulation the answer? Common assumptions among those reporting on the issue seem to be:
1. Dietary supplement manufacturers do not have to prove that their products work.
2. Dietary supplements are allowed to make whatever claims they want.
3. Dietary supplement manufacturers do not have to prove safety of their products.
4. Dietary supplements are not regulated by the FDA.
Are these statements true?
The FDA defines a dietary supplement as a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet.” and includes, but is not limited to, vitamins, minerals, herbs, and amino acids. Such products are not intended to diagnose, cure, mitigate, treat or prevent a disease so they cannot be subjected to a standard of efficacy that would be expected of a drug product.
However, when a dietary supplement makes a claim, e.g., that it is going help a person lose weight, lower their cholesterol or improve their sexual stamina, then there is an assumption that it is going to have an actual pharmacological effect on one’s body. There are three types of claims allowed by the FDA - health claims, nutrient content claims and structure function claims – none of which are the same as a drug claim and for which there are applicable regulations already in existence.
With regard to safety, it is true that the manufacturer, not the FDA, is responsible for ensuring that the marketed product is safe. But again, it must be stressed that there are already rules and regulations that govern the dietary ingredients, the label content, good manufacturing practice, adverse event reporting, etc. How would additional regulations make the product safer?
So if dietary supplements are already regulated, what can be done to prevent bogus or tainted product from reaching the market?
• Increased enforcement of existing regulation through tighter vigilance of the market. Although the FDA has limited resources, perhaps more of them could be allocated to monitoring of the internet and other media where it is not difficult to come across violative products.
• Strong penalties for companies (and their owners/operators) found in violation. In a recent case in which a company was found to have been distributing adulterated product containing a prescription drug, the owner was fined only $60,000, an amount that is unlikely to deter others in a multi-billion dollar industry.
• Better communication between the FDA and industry. While the current regulations do provide the framework, they are numerous and often difficult to interpret. Rather than more regulation, perhaps additional guidance documents could developed for industry to help determine what is acceptable in terms of dietary ingredients and making claims.
• Improved consumer education efforts. Despite efforts by the healthcare industry and the FDA to educate consumers on the appropriate use of dietary supplements, there still appears to be far too many people looking for that “magic bullet”.
In closing, it must be noted that there are many reputable, responsible dietary supplement manufacturers who make good products and follow the laws and regulations in existence. They should not be penalized because others choose not to, nor should consumers be deprived of these products for which there is a strong demand.