What Happened
A recent article in NutraIngredients, a trade publication focused on the “functional food and dietary supplement industry,” helped answer a strange compliance issue with California’s AB-899, a law enacted in 2023. As explained in last week’s blog, AB-899 requires baby food manufacturers to: 1) test their products for arsenic, cadmium, lead, and mercury made on or after January 1, 2024; and 2) disclose the test results for products made on or after January 1, 2025, including making publicly available on its internet website the name and level of each toxic element.
The dietary supplement industry apparently did not consider until recently that their products met the definition of “baby food.” The only exception to the definition of baby food is infant formula. There was no mention of dietary supplements in the exemption. Some industry representatives are complaining about not being told earlier and threatening to challenge the law, according to the article.
Under federal law, dietary supplements are a type of food. Food is broadly defined to mean “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Dietary supplements are specifically named as an example of food in FDA’s definition of food when it comes to registering food facilities, importing food, maintaining records, detaining food. FDA’s FAQs on dietary supplements makes clear that “whatever their form may be, the Dietary Supplement Health and Education Act of 1994 places dietary supplements in a special category under the general umbrella of “foods,” not drugs . . .”
California law has a similar definition of food where food “means either of the following: (a) Any article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal. (b) Any article used or intended for use as a component of any article designated in subdivision (a).” No provision in California law dealing with dietary supplements excludes the products from the definition of food.
Why it Matters
CDC identifies vitamin D, iron, and zinc as three important nutrients for babies and young children. The agency provides suggestions to get these nutrients from conventional foods, but recognizes that dietary supplements may be needed, in consultation with a doctor or nurse. Similarly, the Academy of Nutrition and Dietetics encourages parents to ask their pediatrician about supplements, such as iron, vitamin D, and vitamin B12, for babies. Probiotics are also increasingly common dietary supplements for babies.
Arsenic, cadmium, lead, and mercury can contaminate some dietary supplement ingredients, especially herbs, botanicals, or minerals, from the environment. For example, lead and zinc are often found together when mined.
Studies have documented arsenic, cadmium, or lead levels in dietary supplements. For example, a 2020 study of 277 dietary supplement samples (60% were from the U.S.), with an average daily intakes of 0.73 μg of cadmium, 0.85 μg of lead, and 0.67 μg of arsenic. More recently, a study of prenatal vitamins found amounts above established purity limits in 14.9% for arsenic, 4.3% for lead, and 27.7% for cadmium. In all cases the concentrations varied widely. There were no studies specifically on dietary supplements for babies.
Our Take
Companies that make dietary supplements intended for babies and children younger than two years of age must comply with AB-899. As responsible businesses, they should already be testing each lot of their product for arsenic, cadmium, lead, and mercury, and the NutraIngredients article notes this might be happening as part of manufacturers’ best practices. Now they need to make those results publicly available to enable consumers to make educated decisions associated with their health.
If they are not testing and disclosing, they should do so immediately. Such action would be far more productive than blaming the California Department of Public Health (CDPH) or threatening legal action.
Claims that the amounts of these four toxins are small or inconsequential are contrary to the available evidence and the scientific consensus that there is no safe level of exposure to elements such as lead. If they fail to disclose the results, the California Attorney General and CDPH should consider taking enforcement action.