On June 8, Texas Attorney General Ken Paxton announced an industry-wide investigation into protein powder manufacturers based on concerns of heavy metals, such as lead and cadmium, found in popular protein powders.
Paxton cited research from Consumer Reports (CR) claiming lead levels in plant-based protein powders were, on average, nine time higher than those made with dairy proteins such as whey and twice as high as beef-based products. Three products also exceeded CR’s “level of concern” for cadmium and inorganic arsenic. He also cited a separate study from the Clean Label Project.
The natural products industry previously criticized CR’s testing as misleading and stated the heavy metal levels found in the products are well below federal limits.
Paxton is investigating manufacturers for potential violations of the Texas Deceptive Trade Practices Act (DTPA). The investigation will determine whether companies “falsely marketed or misrepresented the safety and contents of their products” and “whether they failed to disclose known information about heavy metal contamination” in violation of Texas law.
“Protein is a vital macronutrient for human health, and Texans deserve clean protein powders without having to worry whether the products contain heavy metals or other harmful chemicals,” said Paxton. “Far too many corporations have snuck harmful ingredients in their products, and I am committed to doing everything I can to help Make America Healthy Again.”
A natural products industry scientist, the Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) responded to the investigation.
Dr. Gene Bruno, The Vitamin Professor, chief scientific officer at Nutraland USA (Irvine, CA), said it is important to understand the difference between federal standards and California Proposition (Prop 65), which take different approaches to heavy metals in dietary supplements.
“With regard to federal standards, the FDA [U.S. Food and Drug Administration] generally focuses on safety and risk of harm, whereas Prop 65 is not a product standard but a consumer warning law. It requires businesses to provide a warning if exposure to certain chemicals exceeds specified thresholds, even when the product is legal to sell and meets federal requirements. In short, FDA federal standards focus on whether a product is adulterated or unsafe, whereas Prop 65 focuses on whether consumer exposure exceeds extremely conservative warning thresholds,” Bruno explained.
Bruno added Prop 65 limits are generally more stringent than federal requirements because they are based on exposure levels that trigger warnings rather than levels that necessarily indicate a product is unsafe.
“Consequently, a dietary supplement can comply with federal regulations yet still require a Prop 65 warning for California consumers. For example, a supplement containing 1 µg of lead per daily serving may be legally marketed under federal law but trigger a Prop 65 warning because it exceeds California’s 0.5 µg/day reproductive toxicity threshold,” Bruno said. “If the Texas Attorney General’s investigation is based upon federal standard, that is reasonable. If it is based upon California Prop 65 standards, that doesn’t really provide a foundational strategy for assessing product safety.”
“CRN supports strong quality standards and transparency across the supplement industry. However, any evaluation of heavy metals in protein products should be based on sound science, appropriate risk assessment, and the recognition that trace levels can occur naturally in agricultural ingredients. Manufacturers employ quality controls in sourcing and manufacturing to reduce levels and conduct robust testing to help ensure product safety and consumer confidence,” said a spokesperson for CRN.
On June 9, Daniel Fabricant, PhD, president and CEO of NPA sent a letter to Paxton requesting a meeting to provide context on the federal regulatory framework on protein powders marketed as dietary supplements and conventional foods.
Fabricant stressed manufacturers are already subject to enforceable federal requirements including FDA current good manufacturing practices (GMPs). These regulations govern identity, purity, strength, composition, contaminant controls, hazard analysis, preventative controls and manufacturing conditions designed to prevent adulteration.
Fabricant also cautioned against “incomplete or non-transparent third-party testing data” on the basis for broad regulatory action. He noted that trace levels of environmental contaminants such as lead, arsenic, cadmium and mercury can appear in food products because they elements naturally occur in soil, water and air.
“The third-party testing data cited by your office, generated by the Clean Label Project, does not account for the robust safeguards our members implement throughout their manufacturing process, nor does it reflect the scientific consensus of the federal agencies that Congress has charged with regulating dietary supplements,” Fabricant said. “Critically, the Clean Label Project has a documented history of withholding its full testing methodologies, which substantially undermines its reliability as an authoritative source.”
For more information, visit www.npanational.org or www.crnusa.org.
