As dietary supplements rise in popularity, consumer advocates, regulators and lawmakers have become increasingly concerned that the current regulatory system is inadequate to ensure the products on the market are safe. Millions of Americans rely on dietary supplements every day to improve their health and boost their immune systems. The 50 billion dollar industry has more than 50,000 products on the market — increasing from just $4 billion with 4,000 products in the last 25 years. In the last year alone, the industry saw a record-high 12.1% annual increase in sales, which experts attribute to the COVID-19 pandemic that instilled fear into consumers and drove them to obsess over immune-boosting products.

While the Dietary Supplement Health and Education Act (DSHEA) was introduced in 1994 to give the Food and Drug Administration (FDA) authority to regulate products in the category, many still argue the category is insufficiently regulated. Consumer advocates claim fraudulent and adulterated products containing hidden drugs or other undeclared ingredients remain on the market, purchased by consumers everywhere.

Additionally, there are hundreds of companies making false claims about their products — something that’s become more apparent during the pandemic. There has been an influx of companies that are falsely marketing supplements and other products claiming they can prevent, treat or cure the COVID-19 virus. As a result, the FDA issued several warning letters to companies selling these products and other regulatory agencies — such as the Federal Trade Commission (FTC) and the Department of Justice (DoJ) — have taken action to protect consumers. For example, consider the case in which the FTC approved a final administrative consent order settling charges that a California-based marketer of a supplement made baseless claims that it can treat, prevent or reduce the risk of COVID-19.

Members of Congress and consumer advocacy groups, including Dietary Supplement Quality Collaborative (DSQC) see a Democratic White House as an opportunity to impose stricter regulation around dietary supplements. Within the next four years, advocates and U.S. Congress will aggressively push for one of two options: 1.) to tighten up regulation under the DSHEA or 2.) to move dietary supplement regulation under the Pure Food and Drugs Act, which will allow the FDA to more heavily regulate the manufacturing of dietary supplements and remove harmful and misrepresented products from the market.

We don’t know exactly what the regulatory landscape will look like for dietary supplements. But as the Biden administration focuses on advancing measures to protect Americans and consumer advocates continue pushing their agendas, one thing is clear: stronger regulatory framework and stricter enforcement activity is on the horizon for manufacturers.

If you’re a manufacturer in this category, now is the time to reassess your processes up and down the supply chain to avoid recalls and even worse, litigation. Re-evaluate how you’re marketing your product. Do you have proof to support the claims you and others make about your product? If not, it is time to revisit your messaging and marketing strategy.

Make sure your labeling is accurate and complete. Pay special attention to disclosing any active pharmaceutical ingredients or drugs. In these cases, the need for an effective recall is crucial. How prepared are you to take necessary corrective action – whether a full-blown recall, a market withdrawal or other in-market relabeling or repackaging program?

Get ahead of the game by staying up to date on the latest regulatory developments and make any necessary updates to your products, protocols and processes before regulators come knocking at your door and it’s far too late.