FDA Creates Import Alert For Ayurvedic Supplements Linked To High Lead, Mercury Levels
This article was originally published in The Tan Sheet
Executive Summary
FDA creates an alert identifying only products made by Shree Baidyanath Ayurved Bhawan Pvt. at three manufacturing sites. The agency in January also updates around 75 alerts to seize imports of kratom-containing supplements.
FDA on Feb. 16 posted a wave of import alerts for an Indian firm's Ayurvedic supplements potentially contaminated by arsenic, cadmium, lead or mercury following New York City's notification about products containing high levels of those substances.
The agency also has issued around 75 alerts in January making subject to detention without physical examination imports of bulk kratom or supplements suspected to contain kratom, an ingredient that federal officials targeted in a January seizure at an Illinois firm.
The scrutiny of supplements from Shree Baidyanath Ayurved Bhawan Pvt., an Ayurvedic product developer founded in India in 1917, began after New York City in September banned sales of 20 supplements made by the firm based on the city health department's testing that found high levels of mercury, arsenic or lead in the products, available as tablets in 40- to 80-count containers, according to the import alert (Also see "Industry Roundup: Restoring Access Legislation, Adulterated Ayurvedics, UK Claims Enforcement" - Pink Sheet, 18 Sep, 2015.).
The alert identifying products from Shree Baidyanath was created on Feb. 16 and includes only products made by the Indian firm, listing around 100 products from three manufacturing sites. Other food and supplement product import alerts on FDA's website have been compiled for as many as 20 years and have been regularly updated with information on additional products, firms and countries.
The alert lists these Baidyanath brand Bati type Ayurvedics: Agnitundi, Brahmi, Chitrakadi, Gaisantak, Marichyadi, Rajahpravartini, Sarivadi and Shankh; and Saptamrit Lauh type Ayurvedics. The products are made at Shree Baidyanath facilities in Kolata, Bihar, its headquarters; Nabarangapur, Odisha; and Naini, Allahabad.
This reason is stated with each of the nearly 100 products listed on the alert: "FDA has concluded that consumption of any one of the 10 Ayurvedic dietary supplements would likely be injurious to health from either mercury exposure; lead exposure or both."
FDA also reported in January that state health officials in Minnesota alerted the agency to risks of lead poisoning linked to Bentonite Me Baby medicinal clay made by Alikay Naturals, a division of Black Onyx World LLC. Arizona and Kansas officials advised FDA about mercury poisoning linked to Crema Piel De Seda skin whitening cream manufactured in Mexico by Viansilk (Also see "Industry Roundup: USPlabs Cleared In DMAA Suit, AHPA Opposes Blueberry Extract Tariff Hike" - HBW Insight, 1 Feb, 2016.).
In a separate alert created in February 2014 and most recently updated on Jan. 22, FDA listed nearly 75 companies, including 21 US firms, as sources of supplement products suspected of containing kratom (mitragyna speciosa korth), which is indigenous to Southeast Asia. Updates were issued in January for products also made by 47 firms in Indonesia, three in Malaysia and 2 in British Columbia.
FDA since 2013 has questioned kratom's use in dietary supplements but it was not until its first import alerts for products containing the ingredient in 2014 that it stated its position that kratom is a new dietary ingredient without a history of safe use, making it violative in supplements (Also see "Kratom Import Alert Clarifies FDA Deems The Botanical An Unsafe NDI" - Pink Sheet, 21 Mar, 2014.).
However, the continued prevalence of the ingredient in supplements available in the US has contributed to doubts about FDA's enforcement activity and prompted the agency in January to seize $400,000 in RelaKzpro brand supplements containing the botanical from Dordoniz Natural Products LLC, of South Beloit, Ill. The enforcement conducted through the Department of Justice came shortly after Sen. Dick Durbin, an Illinois Democrat and a steadfast critic of the supplement industry, announced plans to introduce legislation for tighter regulation (Also see "FDA Kicks Off Kratom Enforcement With $400,000 Seizure In Illinois" - HBW Insight, 7 Jan, 2016.).