On April 1, 2026, the FDA issued a significant policy clarification targeting the most common remaining workaround: compounders and telehealth providers had been adding a secondary ingredient most commonly vitamin B12 to their semaglutide formulations and marketing them as distinct, patient-specific products not subject to the "essentially a copy" prohibition
Furthermore, while the FDA considers consumption of spirulina through various food products at 0.53 grams per day to be safe, its GRAS assessment also sets a possible daily upper limit of 6 grams in its accepted daily intake calculation (120)
Patients should be fully informed of the potential risk and advised to seek immediate medical evaluation if they develop symptoms such as a lump in the neck, difficulty swallowing, persistent hoarseness, or trouble breathing
The supplier claims a US FDA-notified GRAS status, though this can be a misconception regarding the ingredients safety for food use
and quality manufacturers establish differentiation from opportunistic entrants making exaggerated claims
Glutathione synthase adds glycine to -GC resulting in glutathione formation