# Why Acne Product Stability Is Underregulated
When you buy an acne treatment product, you expect it to work the same way on day one as it does six months later. But the reality is more complicated. The stability of acne products sits in a regulatory gray zone where requirements are inconsistent, enforcement is limited, and manufacturers often have more flexibility than consumers realize.
Acne treatments contain active ingredients like salicylic acid and benzoyl peroxide that need to remain effective throughout a product’s shelf life. These ingredients can break down over time, especially when exposed to heat, light, or moisture. If stability testing is inadequate or skipped, a product might lose its potency before the expiration date, leaving consumers with an ineffective treatment they paid for.
The problem starts with how different regulatory bodies approach cosmetics versus drugs. In the United States, the FDA does not require specific tests to demonstrate the safety of individual cosmetic products or ingredients. This means that many acne products marketed as cosmetics can reach shelves with minimal stability data. Even when acne treatments are classified as over-the-counter drugs, which do face stricter requirements, the testing standards themselves are not always clearly defined or consistently enforced.
The EU has stricter cosmetic regulations through EC No 1223/2009, but even these rules focus primarily on safety rather than efficacy. A product can be deemed safe while still losing its active ingredient potency over time. Stability testing requirements exist, but manufacturers have significant discretion in how they conduct these tests and what conditions they use.
One major gap is the lack of standardized testing protocols for acne ingredients specifically. While preservative efficacy testing uses clear thresholds like 100 CFU/g for microbial contamination, there are no universal standards for how much salicylic acid or benzoyl peroxide must remain stable over a product’s claimed shelf life. Different manufacturers might use different temperature conditions, humidity levels, and time periods when testing their products, making it impossible to compare stability across brands.
Manufacturing practices also contribute to the problem. When companies use contract manufacturers, the responsibility for quality control becomes murky. The FDA has found cases where quality control units failed to properly oversee manufacturing partners or failed to investigate whether stability issues affected multiple product batches. Without adequate oversight, a stability problem in one batch might go undetected across an entire product line.
The cost of rigorous stability testing is another factor. Comprehensive testing requires storing products under various conditions for extended periods, then testing them repeatedly. A company developing an acne product might spend a year or more on stability testing alone. Smaller brands or those trying to enter the market quickly may cut corners, conducting minimal testing or relying on data from similar products rather than testing their specific formulations.
Consumer expectations also create pressure to undertest. Many people want acne products labeled as natural or organic, which often means avoiding chemical preservatives. Without preservatives, products become more unstable and require smaller batch sizes and faster turnover to prevent spoilage. Yet manufacturers may not clearly communicate these limitations to consumers, who expect the same shelf life as conventional products.
The regulatory framework also fails to address real-world storage conditions. Stability testing typically happens in controlled laboratory environments, but consumers store products in bathrooms with fluctuating temperatures and humidity. A product that remains stable in a climate-controlled lab might degrade quickly in an actual bathroom. Regulations do not require manufacturers to test products under these realistic conditions or to provide storage guidance that accounts for typical consumer behavior.
Enforcement is another weak point. Regulatory agencies have limited resources to test products already on the market. The FDA can inspect facilities and review records, but it typically does not conduct routine testing of finished products to verify that they maintain their claimed potency throughout shelf life. This means a product could lose half its active ingredient concentration and remain on shelves undetected.
The situation is further complicated by the classification of acne products. Some are cosmetics, some are over-the-counter drugs, and some fall into gray areas depending on the claims made. This patchwork of regulations means that similar products might face different stability requirements based on how they are labeled and marketed. A company could potentially reformulate a product slightly and move it from a more regulated category to a less regulated one.
International variations add another layer of complexity. A product that meets stability requirements in one country might not meet them in another. Companies selling globally must navigate different standards, but this also creates opportunities to use less stringent testing in some markets while using more rigorous testing in others.
The lack of transparency about stability data is also problematic. Manufacturers are not required to publish their stability testing results or methodologies. Consumers and healthcare providers have no way to compare the stability profiles of different acne products. A dermatologist recommending a product to a patient has no access to the actual stability data that supports the product’s shelf life claim.
Some manufacturers do conduct thorough stability testing because they recognize the importance of product efficacy and brand reputation. But without clear regulatory requirements and enforcement, there is no level playing field. Companies that invest in rigorous testing compete against those that do minimal testing, and consumers cannot easily tell the difference.
The consequences of inadequate stability testing are real. A person using an acne product that has degraded might think the treatment is not working for their skin, when in fact the product has simply lost potency. They might switch to a different product, spend more money, or become discouraged about treating their acne. In some cases, they might turn to stronger treatments or higher doses of active ingredients, potentially increasing the risk of side effects.
Moving forward, acne product stability could be better regulated through clearer testing standards, mandatory disclosure of stability data, and more consistent enforcement. Regulatory agencies could establish specific requirements for how long acne active ingredients must remain stable and under what conditions. Manufacturers could be required to test products under realistic storage conditions, not just laboratory conditions. And consumers could have access to stability information to make informed choices about which products to buy.
Until these changes happen, acne product stability remains a gap in the regulatory system where manufacturers have significant discretion and consumers have limited visibility into whether the products they buy will actually work as promised throughout their shelf life.
Sources
https://allanchem.com/restricted-ingredients-eu-cosmetic-regulation/
https://www.specialchem.com/cosmetics/guide/preservatives-for-cosmetic-formulations