WARNING LETTER
Only Natural, Inc. dba Bio Nutrition, Inc.
MARCS-CMS 605076 —
June 18, 2020
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Robert M. LoMacchio
Recipient Title
President and CEO
Only Natural, Inc. dba Bio Nutrition, Inc.
3580 Oceanside Rd. Unit 5
Oceanside
,
NY
11572
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
WARNING LETTER
CMS # 605076
June 18, 2020
Dear Mr. LoMacchio:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 3580 Oceanside Rd. Unit 5, Oceanside, NY 11572 on January 6-8, 13, and 21, 2020. During the inspection, we collected labels of your products. Based on inspectional findings, a subsequent review of the product labels collected during the inspection, and a subsequent review of your websites at the Internet addresses www.onlynaturalinc.com and www.bionutritioninc.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at
www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
FDA reviewed your websites at www.onlynaturalinc.com and www.bionutritioninc.com in April 2020 and has determined that you take orders there for your Only Natural Alpha Lipoic Acid Plus, Only Natural Berberine 1000, Bio Nutrition Urilow (formerly Gout Out), Bio Nutrition Caraway Seed 1,000, Bio Nutrition Pycnogenol, Bio Nutrition Advanced Berberine 1200, and Bio Nutrition California Poppy Seed products. FDA also reviewed product labels collected during the January 2020 inspection for your Oww-Gout product. The claims on your labels and websites establish that your Only Natural Alpha Lipoic Acid Plus, Only Natural Berberine 1000, Bio Nutrition Caraway Seed 1,000, Bio Nutrition Pycnogenol, Bio Nutrition Advanced Berberine 1200, Bio Nutrition Cholesterol Wellness, Bio Nutrition California Poppy Seed, Bio Nutrition Urilow (formerly Gout Out) and Oww-Gout 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 cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Examples of some of the label and website claims that provide evidence that your products are intended for use as drugs include:
Oww-Gout label:
“Gout…”
Bio Nutrition Urilow (formerly Gout Out) on www.bionutritioninc.com:
“Gout…”
Only Natural Alpha Lipoic Acid Plus on www.onlynaturalinc.com:
“Chromium and Vanadyl Sulfate are added and may stimulate insulin production to regulate blood sugar levels…”
“Chromium may support stable blood sugar levels through insulin utilization, which may benefit those with diabetes and hypoglycemia…”
Only Natural Berberine 1000 on www.onlynaturalinc.com:
“Berberine has been traditionally used as a natural defense against yeast, parasites, fungus and bacteria’s…”
Bio Nutrition Caraway Seed 1,000 on www.onlynaturalinc.com:
“Caraway seeds have been used for centuries…to relieve pain and discomfort associated with intestinal gas and bloating…”
“Irritable Bowel Support…”
Bio Nutrition Pycnogenol on www.bionutritioninc.com:
“[A]ctive compounds act…as an anti-inflammatory…”
Bio Nutrition Advanced Berberine 1200 on www.bionutritioninc.com:
“[H]elpful with fungus, parasites, yeast, bacteria and digestive disorders…”
Bio Nutrition California Poppy Seed on www.bionutritioninc.com:
“Bio Nutrition California Poppy Seed has been used…to promote…pain relief…”
“Pain and Discomfort…”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under Section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” mean directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Only Natural Alpha Lipoic Acid Plus, Bio Nutrition Urilow (formerly Gout Out), and Oww-Gout products are intended for treatment of one or more diseases that are not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your Only Natural Alpha Lipoic Acid Plus, Bio Nutrition Urilow (formerly Gout Out), and Oww-Gout products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Misbranded Dietary Supplements
Even if your Oww-Gout and Bio Nutrition Urilow (formerly Gout Out) products were not unapproved new drugs and misbranded drugs, your products would also be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343]. In addition, your Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, Curcumin 500, Blood Sugar Support, Uric Acid Support, Glucosamine Plus, Sleep Wellness, Kidney Bladder Wellness, Total Skin Wellness, and Pine Pollen products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:
1. Your Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, and Curcumin 500 products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
2. Your Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, Blood Sugar Support, Oww-Gout, Urilow (formerly Gout Out), Uric Acid Support, Glucosamine Plus, Sleep Wellness, Kidney Bladder Wellness, and Pine Pollen products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example:
The Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, and Blood Sugar Wellness product labels state “in a natural base of…” but fails to list the quantitative amount for the ingredients of this base as the total weight of all other dietary ingredients contained [21 CFR 101.36(c)(3)]. If this base is a proprietary blend, it should be identified as such.
Your Oww-Gout, Urilow (formerly Gout Out), and Uric Acid Support products fail to declare (b)(2)-dietary ingredients in the order specified in 21 CFR 101.36(b)(2)(i)(B).
Your Blood Pressure Wellness, Oww-Gout, Urilow (formerly Gout Out), Uric Acid Support, and Total Skin Wellness products declare one or more of the following: “Niacinamide”, “D-3”, “B-1”, “B-5”, “B-6”, and “B-12” which are not the common or usual names for (b)(2)-dietary ingredients, in accordance with 21 CFR 101.36(b)(2)(i) and 101.9(c)(8)(iv)-(v).
Your Blood Pressure Wellness, Cholesterol Wellness, and Blood Sugar Wellness product labels fail to place the “%” sign following the numerical value of the declared Daily Value in accordance with 21 CFR 101.36(b)(2)(iii)(B).
Your Blood Sugar Support product label fails to list chromium in the unit of measurement given in 21 CFR 101.9(c)(8)(iv), as required by 21 CFR 101.36(b)(2)(ii)(B).
Your Cholesterol Wellness, Blood Sugar Wellness, and Total Skin Wellness product labels fail to list the name of the (b)(2)-dietary ingredient in the Supplement Facts label in accordance with 21 CFR 101.36(b)(2)(i). For example, chromium is a (b)(2)-dietary ingredient. The source ingredient, chromium picolinate may be declared in the Supplement Facts label or in an ingredient statement below the Supplement Facts label, in accordance with 21 CFR 101.36(b)(2)(i) and (d).
Your Cholesterol Wellness product fails to correctly declare niacin, a (b)(2)-dietary ingredient; the term “no flush” is considered intervening material and is not permitted in the Supplement Facts label in accordance with 21 CFR 101.2(e). In addition, the source ingredient niacinamide should be declared in parentheses following the listing of niacin in accordance with 21 CFR 101.36(d).
Your Kidney Bladder Wellness product labels fail to declare the source of the Vitamin B-6, in accordance with 21 CFR 101.36(d).
Each of your products’ Supplement Facts labels contain a statement “Each serving supplies” or “Each capsule supplies” or similar statement which is not in accordance with 21 CFR 101.36 and is considered intervening material per 21 CFR 101.2(e).
Your Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, Curcumin 500, Blood Sugar Support, Oww-gout, Urilow (formerly Gout Out), Uric Acid Support, Glucosamine Plus, Sleep Wellness, Total Skin Wellness, and Pine Pollen products bear the following statement: “Percent Daily Values are based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein. [21 CFR 101.36(b)(2)(iii)(D)]
For your products that declare (b)(2)- and (b)(3)-dietary ingredients, the Supplement Facts labels fail to separate (b)(2)-dietary ingredients and (b)(3)-dietary ingredients by placement of a heavy bar. Furthermore, for all products, each Supplement Facts label must place a hairline rule centered between the lines of text to separate each (b)(2)- and/or (b)(3)-dietary ingredient from the dietary ingredient above and beneath it, in accordance with 21 CFR 101.36(e)(5) and (e)(6)(ii).
3. Your Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, Curcumin 500, Blood Sugar Support, Oww-Gout, Urilow (formerly Gout Out), Uric Acid, Glucosamine Plus, Sleep Wellness, Kidney Bladder Wellness, and Total Skin Wellness are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Furthermore, if the whole or entire plant is used, that information must be declared on the Supplement Facts label. In addition, “herb” is not a specific part of a plant.
4. Your Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Support, Oww-Gout, Urilow (formerly Gout Out), Uric Acid Support, Kidney Bladder Wellness, Total Skin Wellness, and Pine Pollen products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. 343 (q)(1)(B)] because the labels fail to declare the number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii).
5. Your Joint Wellness and Total Skin Wellness products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. [21 U.S.C. § 343(i)(2)] in that the labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, the source of the collagen should be included as part of the dietary ingredient name, e.g., bovine or chicken collagen. Furthermore, your Urilow (formerly Gout Out) product declares “Nu-Flo” in the ingredient list which is not the common or usual name of an ingredient.
6. Your Blood Sugar Wellness, Cholesterol Wellness, and Blood Pressure Wellness products are each misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labeling bears nutrient content claims, but the product does not meet the requirements to make such claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product.
Specifically, each product’s label declares “super fruit antioxidants”. The Supplement Facts label of each product does not list any fruit ingredients with an established Reference Daily Intake (RDI). The antioxidant claim found on your products’ labels and the labeling on your website for your Cholesterol Wellness and Blood Pressure Wellness products is a nutrient content claim because it bears the nutrient content claim “super fruit antioxidant” formula but does not meet the requirements to make such a claim. Nutrient content claims using the term “antioxidant” must comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim, as required by 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, as required by 21 CFR 101.54(g)(2). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). Further, nutrient content claims using the term "antioxidant" must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)]. The antioxidant claim on your labeling does not indicate the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol. The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
We note that there are alternative ways to convey the amount of the nutrients in your product to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). Percentage claims for dietary supplements may be stated in accordance with the requirements in 21 CFR 101.13(q)(3)(ii)(A) and (B). If you want to seek authorization to use your current claim, you may submit a petition requesting FDA to authorize a new nutrient content claim for one or more of the nutrients in your product (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.
The violations cited in this letter are not intended to be an all-inclusive list 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 all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
We also offer the following comment:
1. Your Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, Blood Sugar Support, Curcumin 500, Oww-Gout, Urilow (formerly Gout Out), Uric Acid Support, Glucosamine Plus, Sleep Wellness, Kidney Bladder Wellness, Total Skin Wellness, and Pine Pollen products contain the phrase “additional ingredients” which is not in accordance with 21 CFR 101.4(g).
Within fifteen (15) 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, as well as copies of related documentation. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Please send your reply to the Food and Drug Administration, Attention: Scott R. Izyk, 1 Winners Circle, Suite 110, Albany, NY 12205 or email at scott.izyk@fda.hhs.gov. If you have questions regarding this letter, please contact Scott R. Izyk, Compliance Officer at
518-453-2314
x1012
.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
06/30/2020
Regulated Product(s)
Drugs
Food & Beverages