Department of Health and Human Services
Public Health Service
212 3rd Ave S
November 2, 2005
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Allen M. Petro, Owner
714 30th St
Monroe, WI 53566-3522
Ref. No. MIN-06-12
Dear Mr Petro:
An inspection of your facility located at 714 30th St, Monroe, WI, was conducted by an investigator from the Food and Drug Administration (FDA) on May 18, June 1 and June 14, 2005. This inspection verified that your firm manufactures and distributes multiple products for both human and animal consumption. Our review of your product labels, labeling and internet site, www.ana-tech.net, reveals that several of your animal products are adulterated under section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 351(a)(5)] because they are new animal drugs that are unsafe within the meaning of section 512 of the Act [21 USC 360(b)]. Additionally, our review finds that your human consumption product, Pralin, is an unapproved new drug that may not be introduced into interstate commerce under section 505(a) of the Act [21 USC 355(a)]. Further, several of your products for human consumption are misbranded within the meaning of sections 403(q)(1) and 403(q) (5) (F) of the Act [21 U.S.C 343(q)(1) and 21 USC 343(q)(5)(F)].
Animal Drug Products
Section 201(g) (1) (B) of the Act [21 USC 321(g) (1) (B) ] defines a drug as any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Section 201(v) of the Act [21 USC 321(v)] defines a new animal drug as one in which the composition is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. New animal drugs may not be marketed in the absence of an approved New Animal Drug Application (NADA) demonstrating the safety and effectiveness of the product as required under section 512(a)(1) of the Act [21 USC 360b(a)(1)]. For example:
- The statement, "If symptoms persist after 7 days use X-IT in conjunction with antibiotics," made on the label for your "X-IT(W)" product implies that this product is a drug.
- Your product "NO MORE" is identified on the label to be a [de]wormer for use in cats and dogs.
The representations on the labeling for these products indicate that the products are intended for use in the prevention and treatment of disease in animals. The products are therefore drugs under section 201(g)(1)(B) of the Act [21 USC 321(g) (1) (B) ]. The products are also "new animal drugs" under section 201(v) of the Act [21 USC 321(v)] because FDA is not aware of any scientific evidence showing the products are generally recognized as safe and effective.
Because none of the products listed above are covered by an approved NADA, as required by section 512 (a) (1) (A) of the Act [21 USC 360b(a) (1)], the products are unsafe under section 512(a) [21 USC 360b(a)], and thus are adulterated pursuant to section 501(a)(5) of the Act [21 USC 351(a)(5)].
You also offer several direct-fed microbial products, which you refer to as "probiotics." Your internet site includes a segment on the benefits of "probiotics," which you have identified as "naturally occurring beneficial organisms that inhibit disease causing organisms." The direct-fed microbial products include:
Pro-Form Gold for Equine
Dairy Pak-600 Plus for all Classes of Cattle
The claims identified on your website include, but are not limited to:
- Under the heading for Probiotics:
- "…using Probiotics instead of antibiotics…"
- "…normalizes the intestinal pH…"
- "…directly inhibit disease causing bacteria by producing several antimicrobial substance…"
- "…unfavorable to E Coli and other gram negative bacteria. Finally, the hydrogen peroxide is unfavorable to most pathogenic bacteria, and even viruses…"
- "…used as treatment, especially in scouring animals … treat mastitis…"
- Under the heading for Testimonials:
- Dairy-Pak-600 Plus —"…increase in milk production … somatic cell count started to drop … less clinical mastitis…"
- X-IT — "…hoof problems … no new cases of hoof rot or abscesses…"
- Ana-Fresh — "no more DA's … milk went up to 300 pounds per milking…"
The representations on the website for these direct-fed microbial products establish their intended use in the treatment and prevention of disease in animals. The products are therefore drugs under section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)]. The products are also "new animal drugs" under section 201(v) of the Act [21 USC 321(v)] because FDA is not aware of any scientific evidence showing the products are generally recognized as safe and effective.
Because none of the products listed above are covered by an approved NADA, as required by section 512(a)(1)(A) of the Act [21 USC 360b(a)(1)], the products are unsafe under section 512(a) [21 USC 360b(a)], and thus are adulterated pursuant to section 501(a)(5) of the Act [21 USC 351(a)(5)].
New Drug for Human Use
We also reviewed the labeling for the product, Pralin, marketed by your firm, and have determined that it is promoted for conditions that cause it to be a drug. Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [section 201(g)(1)(B) of the Act, 21 USC 321(g)(1)(B)]. The labeling for Pralin in the pamphlet entitled "What Can Pralin Do For You?" bears the following claims under the heading "Benefits of Using A Prebiotic/Probiotic Dietary Supplement:"
- "Inhibits growth of harmful bacteria and food poisoning pathogens such as ecoli [sic], salmonella, plus other disease causing bacteria."
- "Reduces constipation."
- "Treatment of traveler's and antibiotic diarrhea."
- "Helps prevent infections by harmful bacteria."
- "Yeast infections. Fungal infections."
- "Vaginal and urinary tract infections."
The pamphlet also includes claims in the form of a testimonial:
"I picked up my daughter early from school yesterday to take her to the doctor, she had a cold. … I couldn't get her in to see the doctor so I started giving her Pralin repeatedly until bedtime. The next morning she got up and all her symptoms were gone. We find Pralin is good for many ailments, headaches, sore throats, heartburn and stomach aches."
These claims cause your product, Pralin, to be a drug as defined in section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)]. Because the product is not generally recognized as safe and effective when used as labeled, the product is also anew drug under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to determine that the drug is safe and effective.
Misbranded Dietary Supplements
In our review of the labeling for your products for human consumption, we found several of these products to be misbranded within the meaning of sections 403(q)(1) and 403(q)(5)(F) of the Act [21 USC 343(q)(1) and 21 USC 343(q)t5)(F)], in that the nutrition information is not presented in the required format, set out in Title 21, Code of Federal Regulations (21 CFR), 101.36. The nutrition information for the following products does not meet the format requirements:
- Marine Coral Calcium
- CoQ-10 50 mg
- Soothing Caps
- Vitamin E 400 I.U.
- Selenium 200 mcg
Some examples are as follows:
- The label for your product, Soothing Caps, does not identify the Percent Daily Value for Magnesium as required under 21 CFR 101.36(b)(2)(iii).
- The label for your product, Marine Coral Calcium, does not correctly declare the mineral dietary ingredients identified in the Supplement Facts as "trace minerals with natural variability." Any of these dietary ingredients that is present in an amount that can be declared as zero (i.e., less than 2% of the DV) under the criteria of 21 CFR 101.36(b)(2) and 21 CFR 101.9(c), should not be listed in the Supplement Facts at all. [see 21 CFR 101.36(b)(2)(i)]. Calcium and iron must be declared in the Supplement Facts when they are present in amounts equal to or greater than 2% of the Daily Value (DV) [see 21 CFR 101.36(b)(2)]. Other minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) may be declared voluntarily if they are present in amounts equal to or greater than 2% of the DV, and such minerals must be declared in the Supplement Facts when they are added to the product for purposes of supplementation, or when a claim is made about them. The quantitative amount by weight and percent of the DV of each of the mineral dietary ingredients must also be listed in the Supplement Facts, as required under 21 CFR 101.36(b)(2). The label for your Marine Coral Calcium product also does not declare the minerals in the correct order [see 21 CFR 101.36(b)(2)(i)(B)] and includes extraneous material not permitted within the Supplement Facts panel.
- Your product, Colostrum, is further misbranded within the meaning of sections 403(q)(1) and 403(q)(5)(F) of the Act [21 USC 343(q)(1) and 21 USC 343(q)(5)(F)] in that the nutrition labeling of the dietary supplement does not comply with the requirements of 21 CFR 101.36. Your product's label lists "crude protein," "crude fat," and "crude fiber" as dietary ingredients in the Supplement Facts. Protein, total fat, saturated fat, and dietary fiber are among the dietary ingredients required to be declared in the Supplement Facts when they are present in amounts that exceed the amount that can be declared as zero in nutrition labeling under 21 CFR 101.9(c) [see 21 CFR 101.36(b)(2)(i)]. However, these dietary ingredients must be listed according to the nomenclature specified in 21 CFR 101.9 [see 21 CFR 101.36(b)(2)(i)(B)]. Under 21 CFR 101.9, fat must be listed as "Fat, total" or "Total fat" [21 CFR 101.9(c)(2)]; fiber must be listed as "Dietary fiber" [21 CFR 101.9(c)(6)(i)]; and protein must be listed as "Protein" [21 CFR 101.9(c)(7)].
You should notify this office in writing within 15 working days of receiving this letter of the steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.
In addition to the violations described above, FDA has the following comments concerning your products for human consumption. Your product, Inulin, is not labeled with a statement of identity and is not in compliance with section 4 of the Fair Packaging and Labeling Act (FPLA). Section 4 of the FPLA [15 USC 1453(a)(1)] requires that any "consumer commodity," as defined in section 10(a) of the FPLA [15 USC 1459(a)], shall bear a label specifying the identity of the commodity. The label for your Inulin product lacks sufficient information as to the nature of the product, for example, skin cream, dietary supplement, etc. Though the label does not identify Inulin as a dietary supplement, it does include the disclaimer for dietary supplements found in section 403(r)(6)(C) of the Act [21 USC 343(r)(6)(C)] ["These statements have not been evaluated by the Food and Drug Administration…"]. If Inulin is intended to be a dietary supplement, the label must identify the product as such [see section 403(s)(2)(B) of the Act [21 USC 343(s)(2)(B)] and 21 CFR 101.3(g)].
Further, if Inulin is a conventional food or a dietary supplement, its product label does not comply with the applicable nutrition information requirements for dietary supplements (see 21 CFR 101.36) or conventional foods (see 21 CFR 101.9). For example, the nutrition information box on the product label is titled "Essential Facts You Should Know." If the product is a dietary supplement, that box must be titled "Supplement Facts" [21 CFR 101.36(e)]. If the product is a conventional food, that box must be titled "Nutrition Facts" [21 CFR 101.9(d)(2)]. The label for your product, Angel Creme, also does not include a statement of identity. Like the label for Inulin, the label for Angel Creme includes the disclaimer for dietary supplements from section 403(r)(6)(C) of the Act [21 USC 343(r)(6)(C)]. Dietary supplements must be intended for ingestion (see section 201(ffl(2)(A) of the Act [21 USC 201(ff)(2)(A)]). However, the "Suggested Use" section of the label for Angel Creme states that it is to be applied "only to clean skin," and does not include any use involving ingestion, so this product cannot be a dietary supplement.
The ingredient list for your product, Colostrum, lists "Crude Protein," "Crude Fat," and "Crude Fiber" as ingredients. We are not aware of those terms as common or usual names of any ingredient, and it is unclear what they refer to. The ingredients of your product must be listed by their common or usual names, as required by 21 CFR 101.4(a). We suggest that you review the requirements for designation of ingredients in 21 CFR 101.4 and the general principles for common or usual names in 21 CFR 102.5(a) and (d) to help you determine how these ingredients should be declared on the label of your product.
Under 21 CFR 101.4(a)(1) and (g), the ingredients declared on the label of a dietary supplement in capsule form must include the ingredients forming the shell of the capsule. Your product, Soothing Caps, is labeled as being in capsule form, but the only ingredient listed for the product is magnesium. If the shell of the capsule is made up of substances other than magnesium, they must be listed in the ingredient list on the product label.
This letter is not meant to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of the Act and its implementing Federal regulations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
Cheryl A. Bigham, for
W. Charles Becoat
This page was posted on March 28, 2006.