Heavy Metal Contamination Leads to Recall

High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels.

Greetings from Expo West! Today's Warning Letter Wednesday reviews the importance of making and following specifications. Sign up for my weekly blog here, which allows you to search 150+ previous posts.

The batch of high-lead products has been in circulation since 2022 and was recently tested by the Connecticut Department of Consumer Protection's Food & Standards Division, which resulted in the recall. Thank you for finding this CDCP!

Botanicals contain "naturally occurring" amounts of heavy metals, especially in the roots, which is why ingredients and finished product specifications are required to test these items. The American Herbal Products Association (AHPA) is a good resource for understanding specifications, but keep in mind that retailers and states like California (Prop 65) may have their own requirements.

The most common warning letter violations involve specifications being incorrectly written or followed. Here are a couple of Warning Letter Wednesday posts about this.

🔹 1/22/25: Incomplete Batch Records & Ingredient Specifications 

🔹 7/31/24: GMP Manufacturing Lessons

As Warning Letter Wednesday readers know, I am not a company or product basher, which is why I typically don't call out company names in my newsletter. I, however, always provide a link to the warning letter or case so inquisitive subscribers can explore publicly available documents. 

When I look at the recall notice in more detail, I also see labeling issues such as the Statement of Identity "Herbal Supplement" or Dietary Supplement" missing from the Principal Display Panel (PDP). This is considered a major labeling violation, and it signals deeper compliance issues to anyone who is a label reader. The adage "Where there's smoke, there's fire" is often true with labeling violations. 

I then ran Apex Compliance® on the company's website and found several over-the-top disease claims. Since recalls often lead to warning letters, now is the time for this company to remove these risky marketing phrases. Also, to anyone who sells Shatavari, expect the FDA to ask about your specifications and testing during your next inspection.

👉 I write about the joys of being a label reader while traveling here (280k impressions). 

👉 Read about the recall here. 

DATE ORIGINALLY POSTED: 3/5/25

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.