The Food and Drug Administration (FDA) has issued a stern warning letter to Herbal Doctor Remedies, a company operating from Monterey Park, California, highlighting serious violations related to the marketing and distribution of unapproved and misbranded drugs. This action underscores the FDA’s commitment to safeguarding public health by ensuring that products marketed as having therapeutic benefits are both safe and effective, and that their labeling is truthful and not misleading. The warning letter, dated May 25, 2017, and addressed to Mr. Hong J. Shen, the owner of Herbal Doctor Remedies, details findings from an FDA inspection and a review of the company’s product labeling, including its websites www.herb-doc.com, www.ChinaSecretMed.com, and www.theraherb.com.
Unapproved New Drugs: A Core Violation
The FDA’s inspection and review revealed that Herbal Doctor Remedies is marketing a range of products, including but not limited to Asma Aid, Awake, Baby Saver, Cardia Forte, Detensin, Glauco-Catar, Lipidtrol, Lupus Off, Mental Tonic, Pain Stopper, Prostatin, Stroke Saver, Thyro-H, Tumor Off, White Tiger, and Worm Off, as drugs without the necessary FDA approval. Under the Federal Food, Drug, and Cosmetic Act, a product is considered a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The warning letter meticulously lists examples of claims made on Herbal Doctor Remedies’ product labels and websites that establish these products as drugs. For instance, Asma Aid is promoted as “very effective for treating asthmatic cough” and helpful for “bronchitis, bronchial asthma, whooping cough, pneumonia and asthma in children.” Cardia Forte is advertised to “prevent heat attack by lowering cholesterol, LDL, and blood clots” and as “a GREAT FORMULA for lowering cholesterol and for Angina Pectoris.” Such claims clearly indicate a therapeutic intent, positioning these products within the regulatory purview of the FDA as drugs.
Further examples from the FDA warning letter illustrate the breadth of disease claims made:
- Awake: Marketed for “alcoholism, chronic Cole cystitis, duodenal ulcer, chronic pancreatitis, cirrhosis of liver, malnutrition edema, anorexia.”
- Baby Saver: Claimed to “stabilize the fetus, nourish the blood for fetal stability, difficult labor, pain in the waist and abdomen during pregnancy” and for “abortion symptoms at first stage of pregnancy.”
- Detensin: Promoted to “improve lowering blood pressure, strengthen capillary action, cardiac pump” and for symptoms like “nervousness, anxiety, irritability, headache, high blood pressure, orbital and conjunctiva congestion, muscle spasm in the neck and shoulders, dizziness, palpitation and insomnia.”
- Glauco-Catar: Advertised as “the most famous formula for treatment and prevention of glaucoma, cataract without surgery, conjunctivitis, hyperemia, blurred vision, pink eyes, photophobia and dry eyes.”
- Lipidtrol: Claimed to “reduce levels of serum cholesterol and triglyceride, reduce absorption of fatty food and enhance breakdown of fatty tissues; lowers serum glucose level and reduce synthesis of cholesterol and triglycerides; diuretic effects to reduce blood pressure, prevent coronary artery diseases, atherosclerosis and stroke.”
- Lupus Off: Simply stated to be “for Lupus Erthematosus.”
- Mental Tonic: Marketed to “increase mental stability, palpitation, for insomnia, constipation, vertigo” and “for nervousness in children or elderly and for epilepsy.”
- Pain Stopper: Claimed to “relieve pain, swelling and stiffness of the joints… for joint pain of limbs, swelling of the foot… and chest discomfort” and for autoimmune diseases like “rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis/polymyositis, fibromyalgia and myalgic encephalopathy (ME) or chronic fatigue immune deficiency syndrome (CFIDS).”
- Prostatin: Promoted to “reduce painful swelling in the urinary tract” and “for prostatitis, urethritis, cystitis, and inflammation of vagina.”
- Stroke Saver: Marketed “for stroke sequela such as hemiplegia, facial deviation, aphasia, slobbering, lower limbs paralysis, incontinence of urine, etc.”
- Thyro-H: Claimed to be “the best herbal of choice for hyperthyroidism, substitute for radioactive iodine and surgery.”
- Tumor Off: Advertised for “tumor of unknown causes, fibrocystic disease, breast cancer, thyroma, goiter, and cervical lymphadenema” and “as a cancer prevention diet supplement.”
- White Tiger: Marketed for “initial stage or medium stage of diabetes patients” to “help reduce blood and urine glucose levels.”
- Worm Off: Claimed to be “for killing parasite in the intestine such as round worm, tapeworm, hooks worm.”
These extensive health claims firmly classify Herbal Doctor Remedies’ products as drugs under the Act. Furthermore, because these products are not generally recognized as safe and effective for the conditions claimed, they are considered “new drugs” requiring FDA approval before they can be legally marketed. The FDA approval process is rigorous, demanding scientific data and information to prove a drug’s safety and efficacy for its intended uses. Marketing new drugs without this approval is a direct violation of federal law.
Misbranded Drugs: Lack of Adequate Directions for Use
Adding to the severity of the situation, the FDA also found Herbal Doctor Remedies’ products to be misbranded. A drug is considered misbranded if its labeling fails to bear adequate directions for use, meaning a layperson cannot safely use the drug for its intended purposes. This is particularly relevant when products are intended to treat serious conditions that require diagnosis and management by licensed medical practitioners.
The FDA specifically pointed out that conditions such as pneumonia, chronic pancreatitis, pregnancy complications, myocardial infarction, hypertension, glaucoma, coronary artery disease, lupus, epilepsy, chest pain, prostatitis, stroke, hyperthyroidism, cancer, and parasitic infections are not suitable for self-diagnosis or treatment by individuals without medical training. Therefore, providing adequate directions for safe use by a layperson for these conditions is impossible. Marketing drugs without adequate directions for use is another violation of the Federal Food, Drug, and Cosmetic Act.
Implications and Required Corrective Actions
The FDA warning letter makes it unequivocally clear that Herbal Doctor Remedies must take immediate and comprehensive action to correct these violations. Failure to do so could result in significant legal repercussions, including product seizure and injunction. The letter emphasizes that the cited violations are not exhaustive and that Herbal Doctor Remedies is responsible for ensuring compliance with all aspects of federal law and FDA regulations, including labeling and Current Good Manufacturing Practice (cGMP) requirements.
The warning letter mandates a written response from Herbal Doctor Remedies within fifteen working days of receipt. This response must detail the specific actions the company is taking to rectify the violations and prevent future occurrences. The FDA expects documentation and any other information that can assist in evaluating the corrective measures. If complete correction cannot be achieved within fifteen working days, the company must provide a justification for the delay and a timeline for completion.
This FDA warning letter serves as a critical reminder of the stringent regulatory landscape surrounding health products in the United States. For consumers seeking herbal remedies or considering consulting an herbal doctor, it highlights the importance of verifying the legitimacy and regulatory compliance of the products and practitioners they choose. While the term “herbal doctor” might evoke images of natural and safe healing, this case underscores the potential risks associated with unregulated products and the necessity of FDA oversight to protect public health from unproven and potentially harmful remedies. Consumers are advised to seek healthcare advice from licensed professionals and to be wary of products making unsubstantiated disease treatment claims.
