Nature’s Elements, Inc.
FDA issued a warning letter to Nature's Elements, Inc. (Bohemia, NY) following an October 2025 facility inspection and website review, finding that five dietary supplement products — He Shou Wu, Advanced He Shou Wu, Schizandra Berry extract, DHT Blocker, and Cordyceps — bore disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The DHT Blocker and Schizandra Berry extract were additionally cited as misbranded drugs for lacking adequate directions for use. Multiple products were also found adulterated due to serious CGMP violations including absent product specifications, missing master manufacturing records, and no batch production records. FDA warned that failure to correct these violations may result in seizure or injunction.
Flagged claims (9)
Schizandra has also been known to lower blood pressure…
It is beneficial to health issues that are related to stress and has a positive effect on those with physical and emotional depression.
Taking saw palmetto and beta-sitosterol [ingredients in DHT Blocker] together can help signs of alopecia
Saw Palmetto [ingredient in DHT Blocker] inhibits the production of DHT a form of testosterone that contributes to hair loss and prostate problems.
Schizandra has been found to be protective against indigestion and numerous gastrointestinal problems.
Key benefits: Blocks DHT That Causes Hair Loss and Prostate Problems
Shou Wu is used to reduce cholesterol in part to its lecithin content.
Extra DHT levels can cause prostate problems in men like enlarged prostate and BHP [sic] [Benign prostatic hyperplasia] problems which left untreated can lead to sexual dysfunction.
Cordyceps… It is also an ingredient in soups and other foods used traditionally in Chinese medicine for helping sick patients recover from illness.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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