Taspen’s Organics Gets FDA Smackdown

March 7th, 2019

Taspen’s Organics received a lengthy FDA warning letter that tore into the company for making inappropriate disease-treatment claims with regard to at least 10 different products or product lines, misbranding dietary supplements and cosmetics, and violating the FDA’s Current Good Manufacturing Practices (i.e., guidelines that provide minimum requirements that a manufacturer must meet to assure that their products are properly made and of high quality).

The FDA took issue with product labels that claimed tinctures could reduce headaches (Headache Ease); alleviate sickness (Calm Child); relieve cramps, constipation and diarrhea (Digestive Ease); and reduce fevers (Teething). The company’s marketing for creams, salves and oils were called out for inappropriate claims about sun protection, migraine relief, arthritis, fungal infections and inflammation. And the FDA also highlighted several products that were misbranded. For example, the FDA noted that:

Your Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture products are misbranded … because the label is false and misleading in that the label claims “No alcohols” whereas the label lists “gluten free cane alcohol” as one of the ingredients.

Hmm. That’s not good. While it appears the company has attempted to rid its website of inappropriate health claims, some product labels (see above) are still making objectionable claims.

Interestingly, the FDA didn’t make a big deal about the first ingredient in Taspen’s Headache Ease Tincture, which is “Love.” Historically, the FDA hasn’t really felt the love when it comes to that ingredient stating in another FDA warning letter that “‘Love’ is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.”

Remember readers, marketing products as having the ability to treat, cure, alleviate the symptoms of, or prevent developing diseases is simply not permitted by law. If a product really could do all that, then it would be a drug subject to rigorous study and testing to gain FDA approval.

For more on FDA warning letters, click here.

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