USFDA finds different dietary, medicinal claims on Patanjali’s sharbat bottles

Labels on Patanjali’s two sharbat products, earmarked to be sold within India, were found to be having “additional medicinal and dietary market claims” as compared to the ones on bottles set aside for export to America, according to the US health regulator.

The United States and Food and Drug Administration (USFDA) said in its report that the “firm has separate production and packaging areas for exported and domestic products”.

The US food safety laws are more stricter than Indian laws.

If the company is found to be selling a misbranded product in the US, the USFDA can issue a warning letter to stop that product’s import altogether, seize the whole batch of that product, get an injunction from a federal court against the company, and even start criminal prosecution that can lead to fines up to $500,000 and imprisonment of company officials for up to three years.

The inspection of Unit III of the Haridwar plant of Patanjali Ayurved Ltd was conducted by a USFDA investigator named Maureen A Wentzel on May 7 and May 8 last year.

“I observed that the ‘Bel Sharbat’ and ‘Gulab Sharbat’ products are sold under the Patanjali brand name for domestic (India) and international (USA) markets, except the Indian labels have additional medicinal and dietary market claims,” Wentzel said in the establishment inspection report (EIR).

The report was later shared with the company too and the PTI has accessed a copy. Patanjali Group’s spokesperson did not respond to the specific queries sent by the news agency.

Nitin Jain, Deputy General Manager - Exports, Patanjali Ayurved Ltd, has been responsible for the firm’s export business to the US. During the inspection, Jain served as the interpreter for Wentzel.

Same fillers used

She observed that in the plant, the honey was being pumped “from the finished product tank to the fillers” and the same fillers were being “used for domestic and exported honey products”.

The plant also manufactures digestifs, which are post-dinner drinks that aid in digestion.

USFDA investigator wrote in its EIR that once she entered the building where digestif is manufactured, she was “informed that the firm has separate production and packaging areas for exported and domestic products”.

She said while the firm’s laboratory personnel and batch records “appear to follow” written operating procedures, since they were not in operation during the inspection, “I do not know if their written processing procedures correlate with their manufacturing procedures.” The investigator said the export warehouse of the plant had Amla Candy and Herbal Toothpaste apart from the aforementioned two sharbats.

During the inspection, the firm was not producing any goods that were scheduled to be exported to the US, the EIR stated.

In India, if the company is found to be selling food products with “misbranding” or “misleading claims”, a penalty of up to ₹3 lakh can be imposed on it under the Food Safety and Standards (FSS) Act, 2006. The FSS Act also permits the “adjudicating officer” to ask the accountable executive in the company to take corrective actions. If corrective actions are not taken, then such “article of food” shall be destroyed, as per the law.

In 2017-18, Patanjali Ayurved Ltd saw its revenue decline by 10 per cent to ₹8,135 crore. In 2018-19, the company had posted a revenue of ₹9,030 crore.

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