Baby's Only Organic

Baby's Only Organic is among the most unusual brands in the US infant formula category. For over two decades, from 1999 until 2020, the product was sold as a toddler formula for children 12 months and older, with labeling and positioning that deliberately avoided the infant formula regulatory pathway. In mid-2020, Nature's One reformulated the product to meet the nutrient thresholds of FDA 21 CFR 107 and submitted the notification to start selling Baby's Only as an infant formula. That reformulation, and the company's editorial heritage of organic and clean-label positioning, make Baby's Only a reference point that parents researching organic alternatives keep encountering.

Company snapshot

Nature's One is privately held and remains independent, not owned by a major CPG parent, which is unusual for US infant formula (where Abbott, Reckitt/Mead Johnson, Perrigo, and Nestlé dominate). This independence is part of Baby's Only's brand positioning.

What makes Baby's Only distinctive

Four things set Baby's Only apart from the rest of the US organic shelf:

1. The toddler-first heritage

From launch in 1999 until 2020, Baby's Only explicitly marketed itself as a toddler formula, 12 months and up. The AAP has long recommended transitioning to whole cow's milk at age 1, so the "toddler formula" category is contentious, and Nature's One's positioning was that parents who wanted to extend organic formula past 12 months had few options. The label carried "Toddler Formula" prominently and the nutrient profile was designed for children eating complementary foods.

This meant that for 20 years, the product was not regulated under FDA 21 CFR 107, it was a dietary supplement-adjacent product that sidestepped the FDA's infant formula notification regime entirely. Parents using it for infants under 12 months were doing so off-label.

2. The 2020 reformulation

In July 2020, Nature's One announced the reformulation of Baby's Only to meet FDA infant formula nutrient requirements and submitted the formal FDA notification. The product is now legally marketed as an infant formula for 0-12 months, with labeling updated accordingly. This is a meaningful shift: Baby's Only now participates in the same regulatory regime as Similac, Enfamil, and Bobbie.

For parents researching the brand, pre-2020 content and reviews about Baby's Only refer to a different product than what is on shelf today. Ingredient lists, nutrient levels, and regulatory status have all changed.

3. The Clean Label Project Purity Award

The Clean Label Project is a nonprofit that independently tests consumer products for heavy metal and contaminant loads. Baby's Only has received the Purity Award, a third-party certification that the product tested below specified thresholds for lead, arsenic, cadmium, mercury, and other contaminants.

This is not an FDA or USDA certification; it is a private-body certification with its own methodology. Parents should understand it as a supplementary signal of contaminant testing, not a regulatory status.

4. The Premium A2 variant

Baby's Only Premium Dairy is the most nutritionally distinctive product in the line. It combines:

• A2-only cow milk (β-casein A2/A2 herd), one of the few US formulas in this category alongside ByHeart
• Whole milk fat (not skimmed and vegetable oils), structurally closer to European premium formulas like Kendamil and Löwenzahn
• No palm oil, removed in favor of the whole-milk fat base
• Non-GMO and USDA Organic

This specification places Premium closer to European organic premium formulas than to US convention. For an explainer on A2, see A2 β-casein.

Product line

Baby's Only Organic Dairy Infant Formula with DHA & ARA

The standard line. Cow-milk protein (not A2-specific), vegetable oil blend with palm olein, organic lactose and organic glucose syrup solids as carbohydrate sources, algal DHA and fungal ARA, no synthetic preservatives.

See the full SKU record: Baby's Only Organic Dairy Infant Formula.

Baby's Only Organic Premium Dairy Infant Formula (A2)

The flagship variant. A2-only cow milk, whole milk fat, no palm oil, organic lactose-first carbohydrate. Positioned as the premium tier of the line.

Baby's Only Organic Gentle Dairy Infant Formula

A partially hydrolyzed whey variant for sensitive stomachs. This is not an extensively hydrolyzed formula, it is not indicated for diagnosed CMPA. For the CMPA clinical hierarchy see our explainer on cow milk protein allergy.

Regulatory status for parents

Baby's Only is a fully US-registered infant formula. Unlike European imports (HiPP, Holle, Kendamil non-US line), there is no FDA enforcement discretion question and no personal-use import concern. The product is sold openly at US retail: Whole Foods, Target, Amazon, Thrive Market, and Nature's One's direct site. WIC coverage varies by state.

For the full regulatory framework on infant formula in the US vs. imports, see:

• FDA infant formula regulation (21 CFR 107)
• Is European formula FDA-approved?

How Baby's Only compares

Within the US organic shelf, Baby's Only competes directly with:

• Bobbie Organic, pure lactose carbohydrate (no glucose syrup), single-SKU focus, Vermont-based
• Earth's Best Dairy: Hain Celestial-owned, long-established, broader retail distribution
• Happy Baby Organics: Danone-owned, GOS and FOS prebiotic system

The most direct cross-brand parallel to Baby's Only Premium A2 is ByHeart Whole Nutrition (A2-only, US-made, premium positioning). See our ByHeart reference hub for that brand's profile, including its November 2025 recall history.

In the international premium organic space, Baby's Only Premium sits structurally closest to Kendamil Organic (whole milk fat, no palm oil) and Löwenzahn Organics (whole milk fat, Demeter biodynamic), though those are EU-regulated and imported separately.

Editorial notes from María

Baby's Only is the US organic brand with the most interesting recent history. Parents who have used Baby's Only for older children (the toddler era) tend to recognize the brand name positively but may not realize the infant formula product is post-2020. I would not rely on Amazon reviews or blog posts from before 2020 when evaluating the current product, the reformulation is substantive.

The Premium A2 variant, specifically, is worth knowing about. It is the only US-made formula I'm aware of that pairs A2-only protein with whole milk fat (not skimmed and vegetable oils), a combination that's standard in European organic premium lines but nearly absent from the US shelf. Whether A2-only is clinically meaningful for a given baby is separate from the structural question of what's in the tin; the structural answer for Premium is genuinely differentiated.

Baby's Only is not sold by Organic's Best Shop. This profile exists for Atlas completeness, not as a purchase funnel.

For parents evaluating organic options:

• The Atlas root lists every brand documented
• The protein source filter narrows to cow-milk-based formulas
• The no-palm-oil filter highlights the Premium A2 variant alongside European alternatives

Frequently asked questions

Primary sources

1. Nature's One, Inc., "Baby's Only Organic: Product Information." naturesone.com
2. FDA, "Infant Formula Guidance Documents and Regulatory Information." 21 CFR 107. fda.gov
3. Nature's One press release, "Baby's Only Organic Reformulates to FDA Infant Formula Standard." July 2020.
4. Clean Label Project, "Purity Award: Infant Formula Category." cleanlabelproject.org
5. USDA, "National Organic Program." ams.usda.gov

Related reading

• EU Organic vs USDA Organic compared
• Organic certifications compared

This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.