FMCG company Patanjali Foods Ltd has received a regulatory communication from the Joint Commissioner (Drugs), Food & Drug Administration (FDA), Maharashtra State, Nagpur Division, directing the company to recall its Patanjali Karela Jamun Juice and suspend its distribution, sale and supply pending resolution of concerns related to certain promotional and labelling claims.
The development marks a setback for the company, which disclosed the matter in a regulatory filing to stock exchanges.
Regulatory scrutiny
According to the communication, the authority examined certain promotional, labelling, advertising and marketing representations related to Patanjali Karela Jamun Juice and observed that some of the claims may fall within the scope of diseases and conditions specified under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMR Act).
The authority has sought Patanjali Foods’ response regarding the applicability of Sections 3 and 4 of the DMR Act, which govern advertisements and claims relating to certain diseases and conditions.
Pending examination of the company’s response, the FDA has directed the company to undertake several measures, including recalling the product, discontinuing its distribution, sale and supply, withdrawing or modifying certain promotional and labelling representations, and submitting a compliance report before the concerned authority.
No financial impact seen
Patanjali Foods said it is reviewing the contents of the communication in consultation with legal advisors and is formulating an appropriate response.
The company stated that it would take all necessary actions in accordance with applicable laws and regulatory requirements.
In its stock exchange filing, Patanjali Foods said it does not currently anticipate any material impact on its business operations arising solely from the receipt of the notice.
The company further noted that, based on its preliminary assessment, the communication is not expected to have any material financial impact.
No monetary penalty
Patanjali Foods clarified that no monetary penalty has been imposed pursuant to the communication. However, the notice reiterates directions relating to the product’s promotional and labelling claims, including the recall of Patanjali Karela Jamun Juice, suspension of its distribution and sale until the concerns are addressed, withdrawal or modification of certain advertisements and promotional materials, and submission of an appropriate compliance report.
The company said it is evaluating appropriate legal and regulatory measures and will respond to the authority in accordance with applicable laws.
The latest regulatory action comes amid heightened scrutiny of health-related claims and advertising practices in the consumer products and wellness sectors, with authorities increasingly examining whether promotional representations comply with existing legal provisions.