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  5. Doctor's Signature Sales and Marketing International Corp. dba Life Force International - 589559 - 03/27/2020
  1. Warning Letters

WARNING LETTER

Doctor's Signature Sales and Marketing International Corp. dba Life Force International MARCS-CMS 589559 —

Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Mr. Ronald A. Hillman
Recipient Title
CEO and President
Doctor's Signature Sales and Marketing International Corp. dba Life Force International

495 Raleigh Ave.
El Cajon, CA 92020
United States

Issuing Office:
Office of Human and Animal Foods Division 5 West

United States

WARNING LETTER


WL # 589559

March 27, 2020


Dear Mr. Hillman:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Doctor’s Signature Sales and Marketing International Corp. d/b/a Life Force International, located at 495 Raleigh Ave. El Cajon, CA 92020, on July 9, 11, and 15, 2019. During the inspection, we collected labels for your products. Based on the inspectional findings, a subsequent review of the product labels collected during the inspection, and a subsequent review of your website at the Internet address www.LifeForce.net, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

New and Misbranded Drugs

FDA reviewed your website at the Internet address www.LifeForce.net in March 2020 and has determined that you take orders there for your products Colloidal Silver and VitalSTART. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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 these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Colloidal Silver

• “Colloidal silver is known as a natural antibiotic, antifungal, and antiviral substance.”
• “Colloidal silver is also said to be capable of treating fungal infections.”

VitalSTART

• “Maintains Blood Pressure”
• “Avoid heart problems and reduce the risk of a stroke.”
• “Anti-inflammatory”
• “Reduce pain & inflammation.”

Your Colloidal Silver and VitalSTART products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 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” means 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 product VitalSTART is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Furthermore, your product VitalSTART is intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, VitalSTART fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].

In addition, your Colloidal Silver product is labeled as containing colloidal silver as an active ingredient. According to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. § 352].

Misbranded Dietary Supplements:

In addition, your FlexeoPlus, BodyBalance with SeaNine, OsteoProCare, and Recharge +Recovery products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343]. Our review of the labels for these products collected during this inspection establish that they do not comply with the labeling requirements for dietary supplements as required by 21 CFR Part 101 as follows:

1. Your FlexeoPlus and OsteoProCare products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product labels fail to declare the specific species of shellfish sources as required by section 403(w) of the Act.

Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)]; or

The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].

Specifically, each of your FlexeoPlus and OsteoProCare product labels do not declare the specific type of shellfish present in each product, respectively. A declaration of the “(b)(4)” of fish or Crustacean shellfish for purposes of complying with Section 403(w)(2) of the Act [21 U.S.C. § 343(w)(2)] should be made using the acceptable market name provided in FDA's The Seafood List. We note, however, that if a “Contains” statement is used to declare the source of the fish or Crustacean shellfish, we would not object to just the type of fish or Crustacean shellfish being used, e.g., “Contains salmon” or “Contains trout.”

Furthermore, we note that your FlexeoPlus product label includes the statement “Warning: Contains…an ingredient derived from shellfish. Individuals…who are allergic to shellfish should consult their healthcare professional prior to use.” Your OsteoProCare product label includes the statement “Warning: Individuals allergic to shellfish…should consult their healthcare professional prior to use.” These statements are not the appropriate language to declare a major food allergen as defined by section 201(qq) of the Act (21 U.S.C. § 321 (qq)). Major food allergens should be declared using the word “Contains,” followed by the name of the food source from which the major food allergen is derived, printed immediately after or adjacent to the list of ingredients or the common or usual name of the major food allergen in the list of ingredients and followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen).

2. Your Recharge +Recovery product is misbranded within the meaning of 403(a)(1) [21 U.S.C. § 343(a)(1)]. Specifically:

a. The ingredient list on the dietary supplement product does not list an ingredient present in the product, per the batch record ((b)(4)), as required by 21 CFR 101.4(g). The ingredient list is false and misleading in that the product contains (b)(4), but the ingredient is not listed on the label.

b. The label includes the statement “Lemon Balm.” According to the ingredient list, the product contains lemon balm leaf. The label is false and misleading in that lemon balm is the entire plant, but the product contains only the leaf.

3. Your BodyBalance with Sea Nine product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C § 343(r)(1)(A)] because the product label bears the claim “phytonutrient-rich blend of aloe vera & nine sea vegetables” but does not meet the requirements of a nutrient content claim using the term “rich”. To bear the claim “rich” source of a nutrient, the product must contain 20% or more of the reference daily intake (RDI) for nutrients under 21 CFR 101.54(b). However, this regulation does not authorize your claim because there is no RDI for phytonutrients.

We note that there are alternative ways to convey the amount of phytonutrients in your products 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). 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 phytonutrients (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.

4. Your FlexeoPlus, BodyBalance with SeaNine, OsteoProCare, and Recharge +Recovery 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:

• BodyBalance with SeaNine:
a. The Supplement Facts label declares zero amounts of calories from fat, total fat, cholesterol and protein. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
b. The phrase “Not a significant source of vitamin A, vitamin C, iron or potassium” should not appear on the Supplement Facts label. [21 CFR 101.36(b)(2)(i) and 101.9(c)(8)(iii)]

• FlexeoPlus
a. MSM is not the common or usual name of an ingredient. [21 CFR 101.36(b)(iii) and 101.4(a)(1)]

• OsteoProCare
a. The calories per serving fail to be expressed to the nearest 5-calorie increment. [21 CFR 101.9(c)(1) and 101.36(b)(1)]
b. The %DV is not rounded to the nearest whole percent for zinc, selenium, chromium, and molybdenum. [21 CFR 101.36(b)(2)(iii)(C)]

• Recharge +Recovery
a. The %DV is not rounded to the nearest whole percent for thiamine, riboflavin, Vitamin C, biotin, folic acid, magnesium, and manganese. [21 CFR 101.36(b)(2)(iii)(C)]
b. The synonym names of Vitamin B1 and Vitamin B2 for thiamin and riboflavin, respectively, when declared in the Supplement Facts label, must be placed in parentheses after the dietary ingredient name. Vitamin B3, B5, B7 and B9 are not permitted as synonym names for niacin, pantothenic acid, biotin, and folic acid, respectively in the Supplement Facts label. [21 CFR 101.36(b)(2)(i) and 101.9(c)(8)(v)]
c. The (b)(2)-dietary ingredients are in the wrong order. [21 CFR 101.36(b)(2)(i)(B)]
d. The Other Ingredients statement must be placed below the Supplement Facts label. [21 CFR 101.36(d) and 101.4(g)]

5. Your BodyBalance with SeaNine product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” or an appropriately descriptive term indicating the type of dietary ingredients that are in the product, as required by 21 CFR 101.3(g).

6. Your BodyBalance with SeaNine and Recharge +Recovery products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because each label fails to identify the part of the plant (e.g., root, leaves, whole or entire plant) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d).

7. The OsteoProCare product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] in that the product contains a chemical preservative but the label fails to state that fact. Specifically, the label fails to identify the function of a chemical preservative listed in the ingredient statement ((b)(4)) per 21 CFR 101.22(j).

This letter is not an intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

Additional Comments:

• The ingredient list for your Recharge +Recovery product includes “Bacopa monnieri (Bacopin®).” Bacopin® appears to be a (b)(4) of Bacopa monnieri. We note that the listing of botanicals on the supplement facts panel must specify the part of the plant from which the ingredient is derived. 21 CFR 101.36(d)(1).

• Your Recharge +Recovery product includes the statement “All in a base of elderberry juice.” Your ingredient list shows that the product contains “Natural Elderberry Juice Concentrate.” We note that the statement “juice” without modification implies that your product contains juice that is not made from concentrate.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number CMS# 589559 when replying.

If you have any questions regarding this letter, please contact Sara J. Dent Acosta, Compliance Officer, at sara.dent@fda.hhs.gov or (619) 941-3767.

Sincerely,
/S/

Darla Bracy, Division Director
Office of Human and Animal Foods
Division 5 West

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