What the Shampoo Litigation Reveals About Ingredient Safety

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Beauty and Cosmetics Law Africa (BCLA) | Shampoo Litigation Series — Part II

Introduction

The shampoo litigation raises questions that extend beyond the individual products and companies involved. At the centre of the cases are familiar issues in cosmetics regulation such as the safety of ingredients, the quality of the scientific evidence supporting their use, the information provided to consumers, and the decisions manufacturers make when concerns emerge.

These issues are particularly relevant to African markets because some of the brands involved in the litigation are sold across the continent, even though the regulatory systems in different countries differ considerably in their approach to cosmetic ingredients, product testing, labelling and market surveillance.

The litigation does not establish that every product containing DMDM hydantoin is unsafe. Nor does a product reformulation necessarily mean that an earlier formulation was unsafe. What the cases do demonstrate is the importance of having a clear process for assessing ingredient risks and responding when the scientific, regulatory or commercial environment changes.

1. Ingredient Safety Is Not a One-Time Assessment

An ingredient's regulatory status is not necessarily the end of the safety assessment. Cosmetic companies select ingredients for particular functions. Preservatives, for example, are necessary in many water-based products to prevent microbial growth and protect product integrity. The question is whether an ingredient can perform that function safely at the concentration and under the conditions in which it is used.

That assessment can change as new evidence becomes available. A substance may be permitted for use in cosmetics while researchers continue to study its potential effects. Regulators may subsequently review the available evidence and decide whether restrictions, warnings or other measures are appropriate.

This creates an ongoing responsibility for manufacturers. Product safety cannot depend solely on the regulatory position that existed when a formulation was first developed. Companies need processes for monitoring scientific knowledge, regulatory developments, supplier information and consumer complaints. They also need to be able to assess whether new information has implications for products already on the market.

2. Scientific Evidence and Legal Claims Are Not the Same Thing

The shampoo litigation also illustrates an important distinction between scientific evidence and legal allegations. A lawsuit may allege that an ingredient caused a particular injury. That allegation does not establish causation. A scientific study may identify a potential hazard, but that does not necessarily establish that exposure through a particular cosmetic product caused a particular person's injury.

In the DMDM hydantoin cases, the distinction matters. There is established evidence concerning the hazards associated with formaldehyde exposure, and formaldehyde is recognised as a human carcinogen. DMDM hydantoin is also known to release formaldehyde under certain conditions and can cause allergic reactions in some individuals.

The more specific question raised by the litigation is whether the use of DMDM hydantoin-containing shampoos causes the particular injuries alleged by plaintiffs, including hair loss.

That question remains contested. Hence, the courts have had to consider not only the underlying scientific literature, but also whether the evidence is sufficiently reliable and specific to support the claims being made. Scientific uncertainty does not mean that no action is required. But it also means that companies and regulators should avoid treating an allegation as an established scientific fact.

3. Reformulation Raises Its Own Questions

The TRESemmé litigation provides an example of another issue that deserves attention: reformulation. Unilever announced that TRESemmé products sold in the United States would be reformulated to remove DMDM hydantoin. By 2022, the ingredient had been removed from products sold in that market.

A reformulation can happen for many reasons. A manufacturer may respond to regulatory developments, consumer preferences, new scientific information, supply chain considerations, or a broader commercial decision about the future of a product.

The fact of reformulation therefore does not, by itself, establish that the previous formulation was unsafe. It does, however, create an important regulatory question when products are sold across multiple markets: which formulation is actually being sold in each country?

A company may use one formulation across several markets, or it may change individual products to meet local requirements. Consumers and regulators cannot assume that a formulation change announced in one country automatically applies elsewhere. Product registration records and current ingredient information are therefore particularly important.

4. Labelling Is Part of Consumer Protection

Consumers increasingly use ingredient information to decide what to buy. That makes accurate labelling more than one of the principal ways a consumer can understand what a product contains and make an informed choice.

This means manufacturers must ensure that ingredient lists and other product representations are accurate and consistent with the formulation actually being sold. Also, regulators will need to conduct market surveillance, as effective labelling requirements are only useful if there is adequate market surveillance and enforcement.

For consumers, however, an ingredient list has limits. It can identify what is present in a product, but it does not tell the consumer whether an ingredient is appropriate for their individual circumstances or whether a particular scientific claim about that ingredient is well supported. That is why labelling needs to operate alongside broader systems of product safety assessment and regulatory oversight.

What Happens When Standards Differ Between Markets?

The international nature of the beauty industry creates another layer of complexity. A product may be manufactured by the same company and sold under the same brand name in several countries while being subject to different regulatory requirements. An ingredient may be permitted in one jurisdiction but restricted in another. A manufacturer may reformulate a product for one market without making the same change elsewhere. Labelling requirements may also differ.

None of this necessarily means that products sold in one jurisdiction are unsafe. It does mean that regulatory decisions made elsewhere can provide useful information for regulators in African markets.

When a major manufacturer removes an ingredient from a product, when a regulator begins reviewing an ingredient, or when new scientific evidence emerges, African regulators should be able to assess whether those developments have implications for products sold domestically. That requires access to information and sufficient regulatory capacity to act on it.

The African Regulatory Question

For African markets, the central issue is not whether regulators should simply follow decisions made in the United States or Europe. African regulators must make decisions based on their own legal frameworks, scientific assessments, market conditions and public health priorities. The question is whether those systems have the information and capacity needed to make those decisions effectively. This includes knowing which products are registered, which formulations are being sold, which ingredients they contain, and whether manufacturers have responded to significant developments concerning those ingredients.

It also requires attention to how products reach consumers. Formal retail channels may be subject to registration, inspection and other controls. Informal markets and online sales can be more difficult to monitor. Where products are imported through complex supply chains or sold outside established distribution networks, regulators may have less visibility into their origin, formulation and storage conditions. These are not challenges unique to shampoo. They are broader issues in cosmetics regulation.

The shampoo litigation simply provides a useful case study of why they matter.

What Should Beauty Companies Be Doing?

The cases also provide practical lessons for manufacturers and brands. A company selling cosmetic products should be able to identify the ingredients used in each formulation and understand why they are included. It should maintain appropriate records concerning suppliers, specifications, testing and product changes. It should also have a process for monitoring developments that could affect its products. That includes regulatory decisions, emerging scientific evidence, consumer complaints and litigation involving the company's products or ingredients.

Where a company decides to reformulate, the decision should be properly documented. The company should also know when the new formulation entered each market and whether older stock remains in circulation. These are basic elements of responsible product stewardship, but they can become particularly important when a product later becomes the subject of regulatory scrutiny or litigation.

Looking Beyond the Lawsuits

The shampoo cases are still developing, and it would be premature to draw broad conclusions about the safety of every product or ingredient involved. Their significance lies elsewhere. They show how an ingredient can move from being a technical formulation decision to becoming a question of scientific research, consumer expectations, regulatory policy and litigation.

That should encourage a closer examination of how cosmetic ingredients are assessed, how product formulations are monitored, and how information about safety concerns moves between manufacturers, regulators and consumers across global markets. The goal should not be to replicate another jurisdiction's regulatory system. It should be to ensure that consumers have the benefit of sound scientific evidence, accurate product information and effective regulatory oversight.

This article is Part II of BCLA's Shampoo Litigation Series. It is intended for informational and educational purposes and does not constitute legal advice. All information is current as of the date of publication.