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Public Health Service
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506

Telephone (949) 608-2900
Fax (949) 608-4415

WARNING LETTER

VIA UNITED PARCEL SERVICE

September 25, 2013

  W/L# 52-13

John P. Borneman, Ph.D., Chief Executive Officer
Standard Homeopathic Company
210 West 131st Street
Los Angeles, CA 90061

Dear Dr.Borneman :

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."

Misbranding [§§ 503(b)(4) and 301(a)]

As stated above, FDA reviewed the information on your websites regarding a number of your products. Information on your websites, including the indications associated with each active ingredient, documents the intended uses of your products including, but not limited to the following:

Arnicaid

Arthritis Pain Formula

Earache Tablets

Earache Drops

Infant Earache Drops

Hyland's Kids' Kit

Restful Legs

Teething Tablets

Teething Gel

Vaginitis

Hyland's Single Remedies

Antimonium Tartaricum: "Colds with wheezing cough, much mucus, rattling or bubbling in chest. Patient is pale with cold sweat."

Arsenicum Album: "sciatica"

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."

Mercurius Vivus: "gum disease."

Nux Vomica: "Gastric and liver disorders occasioned by high living, overeating or excessive medication."

Phosphorus: "Laryngitis . . . and nerve inflammations."

Ruta Graveolens:

Spongia Tosta: "Advanced stages of croup."

Cell Salts:

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."[1]

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.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.

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.

Your response should be sent to:

Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

Sincerely,
/S/
Alonza E. Cruse
District Director

Cc:
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435

[1] 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."

This page was posted on October 6, 2013.

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