Source: https://www.casewatch.net/fdawarning/prod/2013/standard.shtml
Timestamp: 2019-04-26 02:22:12+00:00

Document:
The Warning Letter to your company on April 29, 2011 discussed primarily current good manufacturing practices (cGMPs) and only a small sample of your firm's misbranded drugs. In the 2011 warning letter and in subsequent communications with your firm, the Food and Drug Administration (FDA or Agency) has repeatedly reminded your firm to take a broad approach to your labeling and review the indications for all your products. In May 2013, FDA conducted a more detailed review of your labeling and marketing information for your firm's homeopathic drug products found on your website at http://www.hylands.com. FDA also reviewed your website www.hylandsearache.com in September 2013. This review revealed that your firm markets numerous drugs that are misbranded in violation of sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 353 and 331] including, but not limited to: "Arnicaid," "Arthritis Pain Formula," "Earache Tablets," "Earache Drops," "Infant Earache Drops," "Hyland's Kid's Kit," "Restful Legs," "Teething Tablets," "Teething Gel," "Vaginitis," "Antimonium Tartaricum," "Arsenicum Album," "Belladonna," "Bryonia Alba," "Cell Salts: #4 Ferrum Phos, #6 Kali Phos, #7 Kali Sulph, #8 Mag Phos, #11 Nat Sulph, #12 Silica," "Chamomilla," "Ferrum Phosphoricum" "Hepar Sulphuris Calcareum" "Hypericum Perfoliatum," "Ipecacuanha," "Magnesia Phosphorica," "Mercurius Vivus," "Nux Vomica," "Phosphorus," "Ruta Graveolens," and "Spongia Tosta."
"Hypericum Perfoliatum 6X HPUS – for nerve injuries due to blows."
"Guaiacum 3X HPUS –acute rheumatism, stiffness and immobility."
"For the relief of symptoms of fever, pain, irritability and sleeplessness associated with earaches in children after diagnosis by a physician."
"The medicines in Hyland's Earache Tablets have been clinically shown to reduce earache symptoms during the first 48 hours of the episode."
"Calcarea Carbonica 30C HPUS - for throbbing, pulsing pain in ears."
"Sulphur 30C HPUS: for ear pain with burning sensation."
The name of product indicates the intended use for earaches.
"Unlike conventional swimmer's ear treatments that simply dry the ears, Hyland's Earache Drops work directly to relieve the pain, itch, and congestion associated with swimmer's ear."
"Temporarily relieves the symptoms of fever, pain, irritability and sleeplessness associated with earaches in children, after diagnosis by a physician. Relieves common pain and itching of swimmer's ear."
"Calcarea Carbonica 30C HPUS: for throbbing, pulsing pain in ears."
"Chamomilla 30X: "Hypersensitivity to pain, rheumatic discomfort . . ."
"Ferrum Phos 30X: Ferrum Phos helps the lungs to distribute oxygen through the body. It helps carry the oxygen in the circulatory system and is useful for inflammations . . . For . . . first stage of inflammations, Ferrum Phos is your remedy."
"Hepar Sulphuris Calcareum 30X: Helps to localize inflammation, as in bringing a boil to a head. Also of value in treating croup . . . and laryngitis."
The name of product indicates intended use for restless leg syndrome.
"Temporarily relieves symptoms of the compelling urge to move legs to relieve sensations of itching, tingling, crawling, and restlessness of the legs."
"Helps reduce redness and inflammation of the gums."
"Belladonna 6X HPUS (0.0000003% Alkaloids, calculated): redness and inflammation"
The name of product indicates the intended use for vaginitis.
"Relief of symptoms of vaginal itching and burning due to vaginal irritation or discharge after diagnosis by your doctor."
"Kreosotum 12X HPUS: is useful in relief of discharges which are yellow, burning and may have an odor. Discharges are frequently accompanied by localized itching."
"Carbolicum Acidum 12X HPUS: helps in the relief of symptoms of discharges that are characterized as "offensive" associated with pains in the back which may radiate to the thighs."
Antimonium Tartaricum: "Colds with wheezing cough, much mucus, rattling or bubbling in chest. Patient is pale with cold sweat."
Belladonna: "Inflammation" and "Sudden onset of violent symptoms characterized by flushing heat and throbbing pain."
Bryonia Alba: "Rheumatic pain worse from motion, better from cold."
Chamomilla: "Hypersensitivity to pain, rheumatic discomfort . . ."
Ferrum Phosphoricum: "Ferrum Phos helps the lungs to distribute oxygen through the body. It helps carry the oxygen in the circulatory system and is useful for inflammations . . . For . . . first stage of inflammations, Ferrum Phos is your remedy."
Hepar Sulphuris Calcareum: "Helps to localize inflammation, as in bringing a boil to a head. Also of value in treating croup . . . and laryngitis."
Hypericum Perfoliatum: Indication for "Nerve Injury"
Ipecacuanha: "Also aids in stopping . . . bleeding from any part of the body."
Magnesia Phosphorica: "It is quick to relieve . . . nerve pains like sciatica."
Nux Vomica: "Gastric and liver disorders occasioned by high living, overeating or excessive medication."
Phosphorus: "Laryngitis . . . and nerve inflammations."
". . . injury to the perosteum (bone covering)."
Spongia Tosta: "Advanced stages of croup."
Cell Salt #4 Ferrum Phos: "ear pain."
Cell Salt #6 Kali Phos: "neuralgic pain"
Cell Salt #7 Kali Sulph: "stiffness in joints"
Cell Salt #8 Mag Phos: "Relaxes spasms of the nerves and muscles. Relieves radiating neuralgic pains"
Cell Salt #11 Nat Sulph: " influenza"
Cell Salt #12 Silica: "Chronic Skin Conditions"
Based on the above labeling and claims, these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)], because they are intended to affect the structure or function of the body.
Section 503(b)(1) of the FD&C Act [21 U.S.C. 353(b)(1)] identifies criteria for determining the prescription status of a product. The products listed above are prescription drugs within the meaning of section 503(b)(1) of the FD&C Act because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Because they may be dispensed only by prescription of a licensed practitioner, these products are misbranded under Section 503(b)(4) of the FD&C Act (21 U.S.C. § 353(b)(4)) in that their labels fail to bear the symbol, "Rx only."
Your products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352 (f)(1)] in that their labeling fails to bear adequate directions for use as defined in 21 C.F.R. § 201.5. The indications for which the products listed above are labeled and marketed are not appropriate for OTC use. If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication.
Furthermore, your products listed above are misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that their labeling is false or misleading because the labeling represents the products as suitable for use by consumers to treat conditions which the Agency has found not appropriate for OTC drug treatment.
Your marketing of the misbranded drug products cited above violates sections 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
We also note that you include customer reviews of products on your websites. These customer reviews are evidence of the intended uses of your products; your firm is responsible for ensuring that statements made by customers and included on your websites do not cause your product to be misbranded under sections 502 and 503 of the FD&C Act [21 U.S.C. 353(b)(1)].
We recognize that the products listed in this response are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. The definition of "drug" in section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency's Compliance Policy Guide entitled, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400)" (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with Section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute any of the products that are the subject of this letter and provide the date(s) and reason(s) you ceased production and if or when you plan to resume production.
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
 We note that the Agency's Compliance Policy Guide entitled, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (the CPG) states that, in accordance with § 503(b)(1) of the FD&C Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, "Caution: Federal law prohibits dispensing without prescription." The CPG was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115); section 126 of FDAMA amended section 503(b)(4) of the FD&C Act to require that the label of a prescription drug product must bear, at a minimum, the symbol "Rx only."

References: § 321
 § 321
 § 353
 § 352
 § 201
 § 331
 § 321
 § 503