The OCA complaint against Honest Company doesn’t list any risks of beta carotene, but just says that it’s not allowed in organic products. In 2012, the National Organic Standards Board reviewed a petition for beta carotene to be added to the allowed substances list, but it was rejected. However, even though the National Organic Standards board said “no” to beta carotene, it’s still being added to formulas under the nutrients and vitamins clause. Ever since 2012, the OCA and other consumer organizations have been trying to get the USDA National Organic Program to enforce what the NOSP advises, however, it’s been continually delayed. In 2014, the Food Safety and Sustainability Center at Consumer Reports reported a baby formula to the NOP for using substances that have been specifically rejected, yet the complaint was ignored. That’s what this lawsuit is all about–trying to get the attention of the NOP.
The beta carotene may not be being added to the formula to provide nutrition, but to keep the oils in the formula from turning rancid. Some people mistakenly call it a preservative–it’s simply an antioxidant. Preservatives stave off bacterial growth; antioxidants keep oils from turning rancid.
Beta carotene isn’t a harmful substance, but manufacturers have other options for antioxidants that *are* on the national substances list, like tocopherol (natural vitamin E) and organic rosemary extract.
The OCA complaint about Honest Co. says that biotin:
[I]s synthetically produced from fumaric acid, a hazardous substance. Biotin is not permitted in milk-based organic infant formulas.
Biotin is a B vitamin (vitamin B7) present in many foods, however, in low amounts. Our intestinal bacteria actually produce biotin in the digestion process. (Source) However, in babies it’s recommended to supplement formula with biotin because their bacteria may not always produce enough. Biotin deficiency can be a cause of Sudden Infant Death Syndrome, so supplementation can be critical to the development and thriving of an infant. (Source) Biotin is also required by the FDA to be present in a baby formula; because the inherent levels in the milk can vary, adding biotin to the formula ensures that these minimum requirements are met. (Source)
While I can’t speak to the legality or appropriateness of biotin being added to an organic product, it’s an essential nutrient that doesn’t pose a health risk (and indeed poses benefit) in an infant formula. Levels present naturally in milks may not be reliable enough to fulfill the legally-required minimum.
The OCA complaint against Honest Company states that DL-Alpha Tocohperol (aka Tocopheryl Acetate)
It is synthetically produced by condensing racemic isophytol with trimethyl hydroquinone. See 21 C.F.R. § 184.1890; 7 C.F.R. §§ 205.105(c), 205.605(b) (permitting tocopherols derived only from rosemary extracts or vegetable oils); Cal. Health & Safety Code § 110820. Dl-alpha tocopherol is a mixture of stereoisomers of 2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl-tridecyl)-6- chromanol. See 21 C.F.R. § 184.1890. The substance has approximately half the vitamin activity of natural vitamin E. The FDA has limited the use of dl-alpha tocopherols “while the agency concludes the general evaluation of all food uses of tocopherols,” 21 C.F.R. § 184.1890(c).
I have to agree with OCA on this one–tocopheryl acetate shouldn’t be allowed in an organic product since the natural form of vitamin E is readily available and on the approved substances list. I’ve written more about the differences between synthetic and vitamin E over on Chemical of the Day. Some studies have even found that tocopherol acetate can deplete your natural levels of vitamin E! See my post about vitamin E supplements here. Should we be freaking out about it? No, probably not. Companies can do better on this one, though.
According to the OCA complaint against the Honest Company:
According to the USDA, nonsynthetic production methods of inositol are not available on a commercial scale. It is produced by extracting phytic acid (inositol-hexaphosphate) from plants such as corn or rice by soaking in a dilute acid solution, such as hydrochloric acid or sulfuric acid, creating phytin (inositol-hexaphosphate salt). The phytin is synthetically converted to inositol by hydrolysis with a strong sulfuric acid solution, and then purified with a reagent like barium to remove the sulfuric acid, phosphoric acid, and calcium or mangesium sulfate. Alternatively, it can be prepared from phytin using ammonium salts such as ammonium sulfate, ammonium chloride, ammonium nitrate, ammonium acetate, or ammonium phosphate for hydrolysis.
Inositol is legally required to be in a baby formula (Source). Inositol is also known as vitamin B8 and is generally recognized as safe by the FDA. (Source) However, according to the Cornucopia Institute, milk has enough inherent inositol to meet the requirements, and synthetic additions have no place in an organic product. (Source)
While inositol doesn’t pose any risks, organic formulators should try to use ingredients like nutritional yeast to provide inositol in its organic form.