A Colorado dietary supplement manufacturer wrongfully included potentially harmful ephedrine alkaloids in one of its products and made improper claims for drug-like effects from others, the FDA said in a warning letter.
The FDA conducted an initial inspection of the Green Herb retail outlet and production facility in Wheat Ridge in February; Green Herb is the name used for the facility and a related website by the company addressed in the letter, MusclMasster.
After later reviewing the website, the FDA conducted a second inspection in the spring, collecting samples of the dietary supplement AL-ER-G that, when tested in a laboratory, revealed the presence of ephedrine, the letter said. The company reported that it had destroyed all ingredients and products containing ephedrine and recalled all AL-ER-G from the market, the agency said.
Making claims that products can cure, treat or prevent disease subjects them to regulation as drugs, which require FDA approval before they can be sold. Green Herb made such claims on labels and its website for products that have not been approved by the FDA, the agency said. Green Herb products such as Vas-Q-Lar, Vir-L IV and Nu Woman are said to help in the treatment of asthma, dementia, eczema, heart and kidney disorders, bronchitis, diarrhea, sinus congestion, arthritis, rheumatism, warts, earache, hay fever, high blood pressure, elevated cholesterol levels, benign prostatic hyperplasia and viral and bacterial infections, the FDA said.
Even if those products did not run afoul of the unapproved-drugs rule, the company’s manufacturing processes do not meet the standards required for dietary supplements, the FDA said.