In times of crisis, great laws are born. But how are they enforced?
In 1906, the Pure Food and Drug Act creating the Food and Drug Administration arose from decades of advocacy by millions of American women and the outcry over unsanitary food preparation in the book The Jungle by Upton Sinclair.
The Dietary Supplement Health and Education Act (DSHEA) was passed in 1994 and intended to ensure the safety of supplements, provide education to help consumers make informed decisions, along with proper labeling and enforcement. The spirit of the law is to balance consumer access to supplements, with ensuring consumer safety. Unfortunately, DSHEA has not been adequately enforced.
Americans are paying more attention to their health than ever before. Dietary supplement sales are skyrocketing. Supplements are defined as any vitamin, mineral, herbal, or botanical supplement added to the diet to improve health. Nutrition Business Journal‘s Supplement Business Report predicts increased use due to COVID-19 will power the industry to the highest growth year since 1997 with a 12.1% increase for 2020.
With the renewed consumer interest in supplements fueled by the pandemic, 2020 would be a logical time for Congress to increase FDA funding and staffing to help the agency better enforce existing regulations.
Serious consequences for violations related to product claims, failure to notify FDA when a new dietary ingredient is placed on the market, and good manufacturing practices would help to better safeguard the health of millions of Americans and send a message to “bad actors” in the dietary supplement industry that irresponsible behavior will not be tolerated.
In response to a 2014 JAMA study highlighting recalled supplements finding their way back onto retail shelves, attorney M. Brandon Smith noted, “Unlike prescription drugs, dietary supplements are considered safe until proven otherwise, and generally only pulled from shelves after complaints of serious injury.”
And therein lies the challenge: DSHEA relies heavily on post-market enforcement, and FDA has simply not done enough.
Specifically during this COVID-19 epidemic, with 150,000 deaths and almost 4 million cases, so far, people are searching for healthy solutions (not cures) and preventive measures. It is estimated that three out of four Americans use dietary supplements.
In the middle of this pandemic, the FDA recently sent warning letters to firms who fraudulently claim to treat, prevent, diagnose or cure COVID-19, noting that: “The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.”
While these warning letters for COVID-19-related products are an important step and are low-hanging fruit, illegal claims continue to run much broader and wider than this current virus. More should be done to protect consumers from falling prey to unscrupulous marketers, while at the same time preserving access to safe, high-quality supplements provided by responsible companies.
A mandatory listing of each dietary supplement would be a great start for progress towards transparency in the industry. The FDA has called for such a mandatory product registry in its 2020 and 2021 budget justifications to Congress.
We at ChromaDex support the concept of a mandatory registry. However, we remain concerned that the FDA does not have the resources necessary from the government to implement and manage such a registry. We join in the call for increased funding for the FDA to carry out its mission and practice greater enforcement of existing regulations, as well as potential new ones.
Our recommendations include more transparent and accurate labeling, a national registry of products that includes detailed labeling information, more protections for intellectual property and stricter enforcement of laws designed to protect the health of consumers.
Many doctors, scientists, and health officials have advocated for laws promoting transparency for years. In Consumer Reports, a prominent doctor explained how a national registry would help.
“Without an FDA registry of supplement products, the FDA has no idea what is even on the market or who makes it,” says Pieter Cohen, MD, an internist at the Harvard Medical School who has studied supplements. “This makes the agency’s job of trying to remove dangerous supplements particularly challenging.”
With a pandemic raging, public confidence in some of our institutions eroding, and people searching for healthy solutions, now is the time for change. Now is the time to ensure the health and safety of millions of Americans who trust and rely on the dietary supplements industry.
Frank L. Jaksch Jr. is co-founder and executive chairman of ChromaDex, a Nasdaq-listed, global bioscience company devoted to cellular health and improving the way people age.
Last Updated August 14, 2020