Department of Health and Human Services
|Public Health Service
Food and Drug Administration
San Francisco District
DELIVERY SIGNATURE REQUESTED
Allen Baron, Owner and President
ABCO Laboratories, Inc.
2450 South Watney Way
Fairfield, CA 94533
Dear Mr. Baron:
The United States Food and Drug Administration (FDA) conducted an inspection of your contract manufacturing facility located at 2450 South Watney Way, Fairfield, CA, from August 26 through September 9, 2011. This letter concerns several products that your firm manufactures and distributes to own label distributors. During the inspection noted above, FDA investigators collected samples and product labeling of some of the products, including “IBU-RELIEF 12,” “Idebenone,” and “Sexual Virility Max” manufactured at your facility. The products that are the subject of this letter refer to those sampled at the time of the inspection. As formulated and labeled, your “IBU-RELIEF 12” and “Sexual Virility Max” are in violation of the Federal Food Drug and Cosmetic Act (the Act).
Your firm manufactures and labels “IBU-RELIEF 12” for the own-label distributor, (b)(4) (dba (b)(4), Inc.). The following statements on your labeling document the intended uses of this product:
• “PAIN RELIEF”
• “HOMEOPATHIC PROFESSIONAL STRENGTH PAIN RELIEVING CREAM WITH ARNICA MONTANA, IBUPROFEN AND METHYL SALICYLATE ….”
Based on these claims, “IBU-RELIEF 12” is a drug under Section 201(g)(1)(C) of the Act [21 U.S.C. § 321 (g)(1)(C)], because it is intended to affect the structure or function of the body. Moreover, “IBU-RELIEF 12” is a new drug within the meaning of Section 201(P) of the Act [21 U.S.C. § 321 (P)] because it is not generally recognized as safe and effective for its labeled use. Drug products intended for the indication such as that for which “IBU-RELIEF 12” is labeled are being evaluated under the Tentative Final Monograph (TFM) for GTC External Analgesics (48 Fed. Reg. 5852). The External Analgesics TFM did not include either the ingredient ibuprofen or the ingredient arnica montana,1 nor were these ingredients evaluated as part of the OTC drug review for any external use, including the indication found in the labeling for “IBU-RELIEF 12.”2
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 “IBU-RELIEF 12.” The marketing of “IBU-RELIEF 12” without an approved application constitutes a violation of these provisions of the Act.
We recognize that labeling identifies these products as homeopathic drugs with active ingredients measured in homeopathic strengths. 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 entitled “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.” The CPG additionally states that “[d]rug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.”
Although arnica montana is an established homeopathic active ingredient, ibuprofen is not a recognized active ingredient in the HPUS or any of its addenda or supplements. Furthermore, to our knowledge, ibuprofen is not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, ibuprofen is not a homeopathic ingredient, and “IBU-RELIEF 12” is not considered a homeopathic drug product under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to “IBU-RELIEF 12.”
SEXUAL VIRILITY MAX
Your firm also manufactures “Sexual Virility Max” for the own-label distributor, (b)(4) (dba, (b)(4), Inc.). FDA confirmed through laboratory analysis that “Sexual Virility Max” (Lot 10090571) contained sulfoaildenaftl and sulfosildenaftl, both of which are phosphodiesterase type-5 (PDE-5) inhihitors and are synthetic chemical compounds that are structural analogs of sildenaftl. Sildenaftl citrate is an active pharmaceutical ingredient found in Viagra, an FDA-approved drug product intended to treat erectile dysfunction (ED). Neither sulfoaildenaftl or sulfosildenaftl was declared on the product label for “Sexual Virility Max.”
The name of the product, “Sexual Virility Max” makes clear that your product is intended to affect the structure or any function of the body of man or other animals. Under Section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must he made in accordance with Section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. However, the structure/function claim quoted above for “Sexual Virility Max” does not describe the effects of nutrients or dietary ingredients in the product. Rather, the claim is made for the product as a whole and relates to its sulfoaildenaftl and/or sulfosildenaftl content. Since sulfoaildenaftl and sulfosildenaftl are not nutrients or dietary ingredients as defined in Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but instead are analogues of an active pharmaceutical ingredient, the claim about sexual virility does not conform to Section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Therefore, “Sexual Virility Max” is a drug under Section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].
Moreover, “Sexual Virility Max” is a new drug within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(P)], because it is not generally recognized as safe and effective for its intended use. 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 FDA approved application is in effect for it. Your sale of “Sexual Virility Max” without an approved application violates these provisions of the Act because it is not the subject of an approved new drug application.
Furthermore, “Sexual Virility Max” is a prescription drug as defined in Section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or potentiality for harmful effect, the method or its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. “Sexual Virility Max” is a prescription drug because it contains several PDE-5 inhibitors; all PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer them.
In addition to the unapproved new drug charges, your “Sexual Virility Max” is misbranded under Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. According to Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs, which bear their FDA-approved labeling, are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because there is no FDA-approved application for your firm’s “Sexual Virility Max,” its labeling fails to bear adequate directions for its intended use, causing it to be misbranded under Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)].
“Sexual Virility Max” is also misbranded under Section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the product’s labeling lacks adequate warnings for the protection of users. There is a potential for adverse events associated with this product, particularly since someone who takes it would be unaware of the presence of sulfoaildenafil or sulfosildenafil in your “Sexual Virility Max” product. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Under Section 502(a) of the Act (21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C.§ 321(n)], provides that, in determining whether an article’s labeling or advertising is misleading there shall be taken into account … not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ….” Your product, “Sexual Virility Max” is misbranded under Section 502(a) of the Act because its labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of this product. Sulfoaildenafil and sulfosildenatil, contained in your “Sexual Virility Max,” may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the product’s label.
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded products, “IBU-RELIEF 12” and “Sexual Virility Max” violates Section 301(a) of the Act [21 U.S.C. § 331(a)].
We acknowledged your action to voluntarily recall “Sexual Virility Max” (Lot 10090571). However, your response is inadequate because it did not address whether you will terminate the manufacturing of “Sexual Virility Max,” or change its formulation to remove sulfoaildenafii and sulfosildenafil contained in the product. We reviewed your firm’s response dated September 29, 2011, and note it lacks sufficient corrective actions.
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.
The inspection determined that you do not manufacture products that comply with Current Good Manufacturing Practice (CGMP) regulations. For example, the manufacturing processes and test methods for your Over-the-Counter (OTC) drug products are not validated and you failed to adequately investigate out-of-specification (OOS) results of water samples. We acknowledge that you have revised pertinent procedures (e.g., master batch records and “Water System Testing” procedure). In addition, you are completing the necessary validations and more thoroughly documenting investigations. Note that the adequacy of these corrective actions will be evaluated at the next inspection.
Also please note, during the inspection, FDA investigators sampled your product Idebenone Capsules, 100 mg, which was manufactured unlabeled for (b)(4) Inc., an own label distributor. FDA confirmed through laboratory analysis the presence of the ingredient, idebenone, in your “Idebenone” product (Lot 10050064). The product “Idebenone” shipped to (b)(4) Inc. did not include labeling and the intended use is not clear. However, for your information, a legally marketed dietary supplement product cannot include “idebenone” as an ingredient. In March 2003, the Agency evaluated Idebenone in response to a 75-day Premarked Notification of New Dietary Ingredients and determined that idebenone is neither a “dietary ingredient” as defined in 21 U.S.C. § 321 (ff)(1), or a “dietary supplement” under 21 U.S.C. § 321(ff)(3)(B).3
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 products, and provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 1000142677.
Please send your reply to the attention of:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Carl Lee, Compliance Officer at 510-337-6737, or by fax at (510) 337-6703.
Barbara J. Cassens
Barry’s Vitamins & Herbs
3551 North Federal Hwy
Boca Raton, FL 33431
1 We acknowledge homeopathic drug products were excluded from the OTC drug review (37 FR 9464, 9466, May 11, 1972). However, as further discussed elsewhere in this letter, FDA does not consider “IBU-RELIEF 12” to be a homeopathic drug product.
2 Although ibuprofen as an active ingredient was first approved by FDA in 1974, that approval was for use as an internal analgesic available by prescription only. We note, on August 21, 2002, FDA proposed to amend the TFM tor OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use (67 FR 54139). However, the proposal to amend the IAAA TFM does not include the topical use of ibuprofen for any indication, nor does the lAAA TFM issued on November 16, 1988 (53 FR 46204) include arnica montana as an active ingredient.
3 Under Section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321 (ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug. There have been numerous investigational new drug (IND) applications for products with the active ingredient “idebenone,” beginning in 1991. Given that idebenone was not marketed as a dietary supplement or as a food before idebenone was authorized for investigation as a new drug, your Idebenone product is excluded from the definition of a dietary supplement under Section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)].
Moreover, the ingredient “idebenone” is not a dietary ingredient as defined in Section 201(ff)(1) [21 U.S.C. 321(ff)(1).] Idebenone is not a vitamin, mineral, herb or other botanical amino acid, dietary substance for use by many to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above. Idebenone is also not a “dietary substance” because it cannot reasonably be viewed as a substance “for use by man by increasing the total dietary intake.” ldebenone is a synthetic analog of coenzyme Q10 that is not food, nor is it used for food. Therefore, the ingredient idebenone is not a dietary ingredient.
This page was posted on August 11, 2017.