Whey Powder | whatsinit

About

What it is and where it shows up.

Whey powder is the spray-dried or roller-dried form of whey, the liquid co-product remaining after milk is curdled and strained during cheese or casein manufacture. It is widely used in processed foods, infant formula, baked goods, and sports nutrition as a source of high-quality protein, lactose, and minerals, and provides functional properties such as emulsification, foaming, and water-binding.

Safety summary

The regulatory and scientific consensus.

Whey powder is affirmed as GRAS by the FDA and carries no IARC classification or established ADI, reflecting a broad safety consensus built on centuries of dairy consumption. It contains major milk allergens (beta-lactoglobulin, alpha-lactalbumin) that can trigger immune reactions in individuals with cow's milk protein allergy. Sweet whey powder retains significant lactose (~70% of dry weight) which may cause gastrointestinal distress in lactose-intolerant individuals, and high-dose protein supplementation may pose a renal burden in those with pre-existing kidney disease.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Whey powder is a conventional dairy food ingredient approved under EU dairy product standards. Whey basic protein isolate was assessed as a novel food under Regulation (EU) 2015/2283; the EFSA NDA Panel (2018) concluded it is safe under proposed uses in infant formula, meal replacement beverages, foods for special medical purposes, and food supplements. No E-number assigned as whey powder is classified as a food ingredient, not a food additive.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Whey and whey powder are regulated as dairy products under FSS (Food Products Standards and Food Additives) Regulations, 2011, Chapter 2.1 (Dairy Products and Analogues). Whey is defined as the fluid separated from curd after coagulation during cheese or casein manufacture; whey powder is explicitly listed with seed lactose permitted in the manufacture of pre-crystallized Whey Powder.source
FDA (Food and Drug Administration) (United States)	Approved	Whey is affirmed GRAS under 21 CFR §184.1979 and whey protein concentrate under 21 CFR §184.1979c; both are approved for use in food generally with no limitation other than current good manufacturing practice (cGMP). No maximum use level is prescribed.source

Who should approach with care

Whose guidance would steer them away.

Other — Individuals with cow's milk protein allergy must avoid whey powder, as it contains major milk allergens including beta-lactoglobulin and alpha-lactalbumin that can trigger IgE-mediated or non-IgE-mediated allergic reactions.

Lactose Intolerance — Sweet whey powder retains approximately 70% lactose by dry weight and may cause bloating, cramping, and diarrhea in lactose-intolerant individuals; demineralized or protein-concentrated forms contain less lactose.

Kidney Disease — High supplemental protein intake from whey powder increases renal nitrogen load and is generally restricted by nephrology guidelines in patients with chronic kidney disease (CKD) stages 3–5.

Infants — Unformulated whey powder is not appropriate as a sole protein source for infants; use must conform to regulatory compositional standards (EFSA NDA Panel 2018; FSSAI infant nutrition regulations) ensuring correct whey-to-casein ratios.

Phenylketonuria — Whey powder is a complete protein containing phenylalanine; individuals with phenylketonuria (PKU) must account for all dietary protein sources, including whey, within their medically prescribed phenylalanine allowance.

Research citations

The sources behind this verdict.

1FDA. 21 CFR §184.1979 – Whey; Direct Food Substances Affirmed as Generally Recognized as Safe. ecfr.gov
2PubMed. Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283, 2019. pubmed.ncbi.nlm.nih.gov
3EFSA. Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283, 2018. efsa.europa.eu
4FDA. Agency Response Letter GRAS Notice No. GRN 000633, 2016. fda.gov
5FSSAI. FSS (Food Products Standards and Food Additives) Regulations, 2011 – Chapter 2.1: Dairy Products and Analogues, 2011. fssai.gov.in

Independently researched5 citations