Has betaine hydrochloride been banned?

Yes. In 1993, the US Food and Drug Administration (FDA) prohibited the use of betaine hydrochloride in over-the-counter medications. This was due to insufficient evidence to classify it as ‘generally recognised as safe and effective’, thereby prohibiting its marketing as a digestive aid. However, as the FDA does not regulate supplements, it remains used by some to increase gastric acid levels. Low stomach acid levels may slow digestion and nutrient absorption, triggering a range of side effects including heartburn, stomach pain, and acid reflux. Many supplements also combine betaine hydrochloride with pepsin. It should be noted that betaine hydrochloride is considered an inhalation hazard, is irritating to skin, eyes, and mucous membranes, and may cause skin allergic reactions. Use with caution.

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