Latest GMP crackdown leaving ‘naive’ cosmetic firms with FDA warnings

By Dan Stanton contact

- Last updated on GMT

Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.

Over the past few months, there has been a spate of US Food and Drug Administration (FDA) warning letters summarising violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals being sent to companies which identify primarily as cosmetic firms.

Most of these firms are based in China or South Korea (though Casmara Cosmetics​, which received a warning last month, is located in Valencia, Spain), and are receiving warnings due to:

  • Insufficient details or evidence  how the company will remediate their operations to ensure compliance with cGMPs
  • Failure to conduct retroactive review and provide risk assessment
  • Failure to provide complete corrective and preventive actions
  • Failure to provide timeline for completion

According to Wanda Eng, a principal consultant at PAREXEL International, this is due to the naivety that pharma products can be made to the same GMP standards as cosmetic products by some over-the-counter (OTC) makers, and is something regulators are cracking down on.

“Cosmetic companies that manufacture OTC drugs are getting Warning Letters from the FDA,”​ she told in-Pharmatechnologist. “It appears that the FDA is actively enforcing cGMPs on OTC drugs. This is their next crackdown like data integrity was for the last several years.”

An FDA presentation given in April last year​ found over one in three warning letters sent in 2016 described data integrity issues at a facility, including lack of control over access to computerized systems, non-contemporaneous record-keeping, and the manipulation or falsification of data.

Eng – a former director of investigations at the FDA – added differences in GMP standards between pharma and cosmetic products are why there is rarely a crossover in a facility between the two categories, and when there is, it often leads to regulatory complications.

“These companies in China and Korea who have been manufacturing these OTC drugs for years are naive about cGMPs,”​ she told us. “They are not sure if their products are classified as OTCs. They do not have the fundamental cGMPs in place.”

Cosmetic, Drug, Soap?

The FDA defines whether a product is a cosmetic or drug through its determined use.

Under guidance entitled ‘Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?*)’​ the FDA states: “Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.”

Drugs must either receive premarket approval through the New Drug Application (NDA) process or conform to a ‘monograph’ for a particular drug category, while cosmetics do not generally require FDA approval.

And specifically from a manufacturing perspective, there are no regulations setting forth specific GMP requirements for cosmetics.

“In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs.”

There is occasionally crossover, the FDA says, for example a ‘cosmetic’ shampoo that is intended to treat dandruff, or toothpastes containing fluoride. In these cases, “such products must comply with the requirements for both cosmetics and drugs.”


* A soap is specifically defined by the FDA as when the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and when the product is labeled, sold, and represented solely as soap.

List of recent Warning Letters sent to OTC drug manufacturers:

Warning Letters




Jiangmen Nowadays Daily Goods, Co., Ltd



  • Failure to test finished products before release to determine if they meet specifications
  • Failure to test active ingredients and components to determine if they meet specifications
  • Inadequate manufacturing equipment
  • Failure to have SOPs

Guangzhou Baiyunshan Pharmaceutical Holding Co., Ltd. Baiyunshan Hejigong Pharmaceutical Factory 



  • Inadequate cleaning of equipment to prevent contamination
  • Failure to adequately qualify suppliers
  • Failure to follow SOPs
  • Inadequate SOPs

Cosmecca Korea Co., Ltd



  • Failure to test finished products before release to determine if they meet specifications
  • Data integrity issues
  • Inadequate quality assurance

Polaroisin International Co., Ltd



  • Failure to test finished products before release to determine if they meet specifications Failure to test active ingredients and components to determine if they meet specifications
  • Expiration dates not supported by stability testing
  • Failure to have process validation
  • Failure to have adequate SOPs

Shanwei Honghui Daily Appliance Co., Ltd



  • Failure to test finished products before release to determine if they meet specifications, including objectionable microorganisms
  • Adequate cleaning of manufacturing equipment
  • Failure to follow SOPs
  • Failure to adequately qualify suppliers
  • Inadequate batch records

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