The composition of FDA-regulated products is coming under increasing scrutiny from FDA, state governments, consumer watchdog groups, and the plaintiff’s bar. In the past year, we have written about, among other composition-related issues:
- FDA’s launch of Operation Stork Speed “to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply,” following a Consumer Reports investigation into heavy metals in infant formula
- FDA’s intention to remove petroleum-based synthetic dyes from the U.S. food supply, FDA’s orders to revoke the authorization for the use of Red No. 3 in food and ingested drugs and to revoke the authorization for the use of brominated vegetable oil in food, and related class action litigation
- State laws and proposed legislation banning or proposing to ban various food and color additives (including West Virginia’s recent ban on Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, Green No. 3, and the preservatives butylated hydroxyanisole and propylparaben)
- FDA’s announcement that it intends to study the presence of metal in tampons and related class action litigation and
- Maryland’s enactment of Rudy’s Law, which imposes heavy metal testing and labeling requirements on baby food manufacturers
Now, a recent investigation by Lead Safe Mama, which routinely conducts heavy metal testing of products on the market, is gaining traction in the media. The investigation found that 90% of the 51 toothpastes and toothpowders tested contain lead, 65% contain arsenic, 47% contain mercury, and 35% contain cadmium. The investigation will inevitably lead to demand letters that threaten class action litigation and may also lead to product recalls.
Companies in the FDA space recognize the importance of ensuring that their product compositions are legally compliant, with both federal and state requirements. But it is important to look beyond compliance to the underlying safety of the product’s composition. This is especially important where there is a gap in federal law, for example, where federal law does not establish a limit for a particular contaminant for the applicable product category. By focusing on compositional compliance and safety, companies will help to protect the brand’s reputation; decrease the likelihood that the company is targeted with demand letters and, if they are, allow the company to more easily fend them off; decrease the likelihood that the company must conduct a recall; and decrease the likelihood that the company is required to reformulate in response to future changes to federal or state law.
Interested in what steps your company can take to evaluate risk or shore up its substantiation for compositional safety? Venable’s Food & Drug Law Group is ready to assist.