Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
March 12, 2013
Natural Medicine Associates, Inc.
7375 Davie Road Extension
Hollywood, FL 33024
Dear Mr. Yakubovsky:
The United States Food and Drug Administration (FDA) conducted an inspection of your own-label distribution center, Natural Medicine Associates, Inc., located at 7375 Davie Road Extension, Hollywood, FL from September 13-14, 2012. During the inspection noted above, FDA investigators reviewed your firm's labeling and marketing information for several products your firm markets and distributes, including "ASTHMA H12," "COLD SORES H16," "ECZEMA H23," "RHEUMATIC PAIN H57," "EYE IRRITATION H25," "FEVER & INFECTION H27," "ACNE H11," "FLU H28," "PROSTATE H39," "CHICKEN POX H72," "EARACHE H77," "FEVER AID H78," "PHOBIA & ANXIETY H56," "ROSACEA & REDNESS RELIEF H58," and "MEASLES H80." Based on our review, these products are unapproved new drugs in violation of sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331 and 355] and misbranded under sections 301 and 503 of the Act [21 U.S.C. §§ 331 and 353].
The immediate container labels and/or promotional material in The Journal of Preventative & Alternative Medicine, published by the Foundation for the Advancement of Alternative Medicine, document the intended uses of these products. This is not intended to be an all inclusive list:
ASTHMA H12: "Helpful in the case of breathing difficulties with no cough, such as . . . mild bronchitis."
ECZEMA H23: "For relief of itching and pain associated . . . dermatological eruptions . . .."
RHEUMATIC PAIN H57: "For relief of pain . . . with rheumatism . . . gout . . . uric acid . . .."
COLD SORES H16: "Relieves symptoms of cold sores, shingles, sores on the body, and fever blisters cause by the herpes virus . . .."
EYE IRRITATION H25: "Relieves pain, itching, swelling, pressure, red and tired eyes and pink eye . . .."
FEVER & INFECTION H27: "Helps reduce fever and fight viral and bacterial infections . . .."
ACNE H11: "To relieve . . . acne rosacea of the face and body . . .."
FLU H28: "Helps prevent . . . flu symptoms and the aches and pains that accompany the flu . . . Also helpful for intestinal troubles . . .."
PROSTATE H39: "To relieve symptoms of prostate swelling and discomfort with frequent urination . . .."
CHICKEN POX H72: "[R]elieve the symptoms of Chicken Pox, such as fever and itching . . .."
EARACHE H77: "For relief of ear pain, earaches and ear infection. It prevents the inflammation from becoming a chronic ear infection."
FEVER AID H78: "Reduces fever and helps fight viral and bacterial infection in children . . .."
ROSACEA & REDNESS RELIEF: "For the relief of the symptoms of dryness of the nose and cheeks associated with widened blood vessels."
MEASLES H80: "To relieve symptoms such as fever, itching and discomfort in eruptive diseases, likes measles, rubella and scarlet fever . . .."
PHOBIA & ANXIETY: "Relieves 'situation specific'. . . panic and anxiety . . .."
Based upon our review of the labeling for these products, and the promotional material you include when you ship your products, for example, The Journal of Preventative & Alternative Medicine, Vol. 4 / No.1-published by the Foundation for the Advancement of Alternative Medicine, we have determined that these products are promoted for conditions that cause them to be drugs within the meaning of 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 any function of the body.
Further, the above products are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because there is no evidence that they are generally recognized as safe and effective for their intended uses.
Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. §§ 355(b) or (j)] is in effect for the product. There are no FDA-approved applications on file for the above products. Therefore, the marketing of these products without approved applications constitutes a violation of these provisions of the Act.
We recognize that many of the products you market purport to be homeopathic drugs. The definition of "drug" in section 201(g)(1) of the 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 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 titled "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)" (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. The CPG defines a homeopathic drug as "Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements."
While you identify many of your products as homeopathic drugs, the labeling of the above products fails to include active ingredients measured in homeopathic strengths. Instead, many of the abbreviated ingredient names listed on the label are not the "Official Short Names" as specified in the Homeopathic Pharmacopeia of the United States (HPUS) and many of the active ingredients listed are not listed in homeopathic strengths. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to these products. Therefore, your products that do not include labeling clearly listing the active ingredient measured in homeopathic strengths are considered unapproved new drugs under section 505(a) of the Act [21 U.S.C. § 355(a)].
The products discussed in this letter are prescription drugs under section 503(b)(1) of the Act. Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] provides that a drug which "because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug." As stated above, your labeling and publications you use to promote the above products discuss therapeutic uses of your firm's products, including the treatment and/or symptoms of conditions such as flu, measles, rubella, scarlet fever, rosacea, viral and bacterial infections, chronic ear infections, panic disorder, anxiety, phobias, and enlarged prostate.. Because these products 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 or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician, they are prescription drugs within the meaning of section 503(b)(1) of the Act. Therefore, the above mentioned products are misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] in that their labels fail to bear the symbol "Rx only." The marketing of these misbranded products violates section 301(a) of the Act [21 U.S.C. § 331(a)].
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law and FDA regulations.
We acknowledge receipt of your correspondence dated September 24, 2012 in response to the FDA Form 483 issued at the close of our investigation of your facility. However, your September 24, 2012 response does not address any issues with respect to the products discussed in this letter.
We request that you respond within 15 days of receipt of this letter with the actions you plan to take in response to this letter. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 days, state the reason for the delay and the time within which you will complete the corrections. Furthermore, please advise this office of what actions you will take to address product(s) that you have already distributed. Address your reply to the U.S. Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions, please contact Ms. Norris at (407) 475-4730.
Director, Florida District
This page was posted on October 6, 2013.