Recently, there have been numerous articles and blogs describing a situation involving death, mayhem, lawlessness, ‘evil doers’ and a government’s inability to protect its people. No, these are not reports on Afghanistan or other global hot spots. They are articles about the dietary supplements industry.
The sentiment conveyed in these articles is perhaps expected and understandable given the recent high profile reports involving potentially unsafe dietary supplements. As we noted in our guest article in January, The Food and Drug Administration (FDA) issued more than 40 warning letters to supplement makers last year. Click here for more on that.
Although they may be well intentioned, claims that dietary supplements pose an immediate threat to the American public; that the Food and Drug Administration (FDA) is unable to protect us; and calls for drastic action, may do more harm than good.
Open debate on topics of public health is important, but it is equally important not to mislead the public into believing that the entire dietary supplement industry consists of rogue actors, unchecked by the FDA or existing regulations, when the opposite is true. Rather than panic, these recent high profile reports call for calm, thoughtful consideration that may in the end improve the already robust system in place for these products.
Eye of the storm
In the eye of the storm is DSHEA which was enacted in 1994 to provide a framework for the regulation of dietary supplements.
DSHEA resolved regulatory inconsistencies, provided definitions and established ground rules for dietary supplement manufacturers and marketers. It established standards for dietary supplement ingredients safety, labeling claims, and the communication of accurate and useful information to consumers.
In addition to the general prohibition against selling adulterated or misbranded products, dietary supplements are subject to DSHEA’s special provision for New Dietary Ingredients (NDI), which are ingredients not marketed prior to 1994. Unless certain exceptions are met, companies distributing such ingredients must provide evidence to FDA documenting their safety.
With respect to claims, DSHEA mandates that manufacturers have substantiation for claims they make about their products, and FDA has provided thoughtful, detailed guidance on what type of scientific evidence is needed to support claims.
DSHEA also requires that manufactures notify FDA about claims they are making, and FDA has an opportunity to object to claims that would cause the dietary supplement to be a drug, such as claims that the product is intended to prevent or treat a disease.
As with any product category, bad news about dietary supplements tends to grab the headlines. However, the fact of the matter is since DSHEA was passed, most of the ‘news’ has been good. DSHEA has allowed countless safe and effective products to be available to the public – calcium, omega-3 fatty acids, vitamin D, folic acid, and iron, to name just a few – without unneeded burdens on the industry or FDA. The public health benefits provided by products like these is immeasurable.
In addition, the FDA, despite personnel and budget constraints, is actively regulating the industry under the existing regulatory framework. Just this month, FDA identified and seized $1.3 million of adulterated supplement products. Click here for that story.
Moreover, since DSHEA was enacted, Congress and FDA have taken several important, considered measures to improve the regulation of dietary supplements. For example, Congress closed an important loophole when it enacted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006, which, for the first time, requires that manufacturers of dietary supplements report serious adverse events associated with their products to FDA.
FDA has also promulgated comprehensive Good Manufacturing Practices (GMP) requirements for dietary supplements. The GMP rules require, again for the first time, that companies have systems in place to ensure that their products are consistently manufactured so that the label accurately reflects what is in (and not in) the products. Measures such as these should reduce the instances of headline-grabbing cases such as those discussed above.
Of course, like any piece of legislation, there may be ways DSHEA can be improved. However, to avoid unintended, unforeseen consequences, any change to the law must be very carefully considered.
Quick-fix or double trouble?
A recent example of the unintended consequences of a well-intended legislative ‘fix’ is the Consumer Product Safety Improvement Act of 2008 (CPSIA). Quickly enacted in response to the public outcry from the findings of lead in some children’s toys, the CPSIA has overwhelmed both the Consumer Product Safety Commission (CPSC) and the industry in mandates that seem to do little to protect public health.
For example, read literally, the CPSIA requires manufacturers of cotton baby blankets to test and certify that their products do not contain lead. While reasonable changes to the law may have been warranted, these changes not only weigh down an industry already overburdened in a difficult economy, they also overburden an already overburdened government agency, and that may impact its mission to protect public health.
That is precisely the outcome that Congress, FDA and the public should seek to avoid. Hasty action concerning a complicated body of law can have unforeseen consequences for the industry, the government and the public. At a time when the issues facing the agency and the Congress require complex analysis, let’s hope that cooler heads prevail.
Ivan Wasserman is a partner, and Svetlana Walker is an associate at Manatt Phelps & Phillips in Washington, DC. They specialize in advertising and labeling issues for the food and dietary supplement sectors.