What FDA Warning Letters Reveal About Compliance Gaps in Cosmetics Facilities

The cosmetics industry is going through a period of regulatory change. With the Modernisation of Cosmetics Regulation Act (MoCRA) now in force, FDA oversight of cosmetics facilities is sharper than ever.

Recent FDA warning letters show that many companies producing cosmetics and over-the-counter (OTC) drug products are still struggling to meet basic compliance expectations.

By looking at recent cases, we can see recurring themes: weak testing practices, inadequate quality oversight, poor documentation, and in some cases, misbranded or unapproved products on the market. These issues not only breach regulations but also put consumers and brands at risk.

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Failure to Test Raw Materials

One of the most common findings is a lack of adequate testing of raw materials. Ingredients like glycerin and ethanol are considered high-risk because they have been linked to lethal poisoning incidents when contaminated with diethylene glycol (DEG), ethylene glycol (EG), or methanol. Yet several firms failed to properly test each shipment.

For example, in its July 2025 letter to Kabana Skin Care, the FDA wrote:

"You failed to adequately test each shipment of each lot of ethanol, used as an active pharmaceutical ingredient, for methanol... The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide."

Similarly, Laboratoire Druide in Canada was cited for relying too heavily on supplier certificates of analysis without performing even a single identity test for each lot:

"You failed to adequately test each shipment of each lot of glycerin at high risk of diethylene glycol (DEG) and ethylene glycol (EG) contamination."

The lesson is clear: for high-risk ingredients, supplier paperwork is not enough. Direct, documented testing is expected.

Inadequate Finished Product Testing

Another recurring problem is failure to test products before release. Both Kabana Skin Care and Amish Origins were found to be distributing products without confirming their chemical or microbiological quality.

The FDA made its position explicit:

"Without adequate testing, you do not have scientific evidence to support whether your drug products conform to appropriate specifications before release."

For cosmetics facilities, this expectation underlies the importance of building in proper laboratory controls, even if the product is not sterile. Skipping this step leaves companies exposed to both regulatory action and safety risks.

Weak Quality Systems and Documentation

The FDA also takes issue when a company's quality unit (QU) is ineffective.

The Dynamic Blending Specialists letter is a clear example:

"Your quality unit did not provide adequate oversight and control over your drug manufacturing operations... Shred bins containing what appeared to be cGMP records were located in your manufacturing and warehouse areas."

This shows how documentation lapses, however small they may seem, quickly translate into compliance failures. Batch records kept "in memory" rather than in writing, as Amish Origins admitted, are equally unacceptable.

The FDA expects attributable, legible, complete, and contemporaneous records at every step.

Cleaning, Validation, and Water Systems

Laboratoire Druide was cited for failing to validated its cleaning processes and for operating a water system that did not meet USP specifications.

The FDA warned that biofilm-forming microbes such as Burkholderia cepacia had not been properly monitored. These kinds of lapses are not minor housekeeping issues; they strike at the heart of contamination control and can affect every product made in the facility.

Misbranding and Unapproved Products

Finally, several cases involved products being sold with claims that pushed them outside the boundaries of cosmetics or OTC monograph drugs.

Amish Origins' "Deep Penetrating" range claimed to relieve coughs, sore throats and sinus trouble, uses that go beyond the approved monograph. The FDA's conclusion was blunt:

"These products are new drugs within the meaning of section 201(p) of the FD&C Act... unapproved new drugs marketed in violation of section 505(a)."

Dynamic Blending faced similar issues with an oral care product FDA described as both unapproved and misbranded. These findings highlight the importance of aligning labelling and marketing claims with regulatory definitions, not just marketing ambitions.

What This Means for Cosmetics Companies

The pattern across these letters is consistent. The FDA is not just enforcing paperwork; it is holding companies accountable for the fundamentals of good manufacturing:

• Test every high-risk raw material lot

• Confirm finished product quality before release

• Validate cleaning, water, and manufacturing processes

• Maintain proper records and documentation

• Ensure the quality unit has genuine authority

• Keep claims within approved regulatory frameworks

Ignoring these basics can lead to recalls, import bans, and reputational damage that no brand can afford.

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