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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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BestLife International, Inc. 02/04/2009

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996


February 4, 2008

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 09-11

Paul T. Baugh, President
BestLife International, Inc.
1341 15th Street
Clarkston, Washington 99403-2460

WARNING LETTER

Dear Mr. Baugh:

This is to advise you that FDA reviewed your website at www.bestlifeint.com in January 2009, and has determined that the products "Sammi's Best™ Soy," "Sammi's Best™ Cultured Organic Soy," "Sammi's Best™ Soya-Rice," "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement," "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement," "Sammi's Best™ Soy, Dutch Chocolate Flavor," "Sammi's Best™ Soy Nog," and "Sammi's Best™ Soychata" are promoted for conditions that cause the products to be 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)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed, on your website include:

o In "Articles: Table of Contents:" "Study after study has shown that soy is an amazing natural remedy that prevents and fights cancer, heart disease, high cholesterol, menopausal symptoms, osteoporosis, and other chronic conditions."

o In "Questions About Soy and Cancer": "What evidence exists that a soy diet is preventative or beneficial in cancer?

At a scientific symposium held at the National Cancer Institute in 1990 it was concluded that soybeans contain at least five compounds with anticancer activity.

Dr. M. Messina and Ms. V. Messina in their book 'The Simple Soybean and Your Health' state that 'soyfoods are-rich in anticarcinogens, substances that, in some way, prevent or control cancer'."

"What are the principal anticancer agents in soy?

. . . These soy isoflavones, genistein and daidzein, are known to inhibit cancer cells grown in the laboratory and in animal models. Research shows that isoflavones have anticancer effects in prostate, breast, colon, lung and skin cancer."

o In "Ten Most Important Benefits of Soy": "Studies have proven that compounds in soy can inhibit the growth of prostrate cancer cells."

These 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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your products "Sammi's Best™ Soy," "Sammi's Best™ Cultured Organic Soy," "Sammi's Best™ Soya-Rice," "Sammi's BestTM Dutch Chocolate Soy Amazing Meal Replacement," "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement," "Sammi's Best™ Soy, Dutch Chocolate Flavor," "Sammi's Best™ Soy Nog," and "Sammi's Best™ Soychata" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

You should take prompt action to correct the violations cited in this letter and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

In addition, we have the following comments regarding the labels of your products that were collected by FDA during the August 5 and 6, 2008, inspection of your processing facility located at 1341 15th Street, Clarkston, Washington.

1. The labels of your Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" products declare the serving size in liquid ounces (e.g., "Use 3/4 dry cup measure per 12 oz. of water") after the powder is reconstituted. However, when a product requires further preparation, such as your meal replacement powders, the nutrition information must be based on the amount of the product as packaged and the Reference Amounts Customarily Consumed (RACC) for the serving size is the amount of the powder that is required to make the reference amount of the food [21 CFR 101.9(b)(9) and 101.12(c)(1)].

2. The labels of your "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" products fail to declare the percent daily values of dietary fiber as required by 21 CFR 101.9(d)(7)(ii). In addition, your labels make a claim about the amount of protein, "24 grams of protein from Soy & Whole Ground Fax [sic] Seeds." However, the nutrition labels do not declare the "percent daily value" for protein as required when a claim is made for a protein [21 CFR 101.9(c)(7)(i)].

3. The labels of your "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's'Best™ Real Vanilla Soy Amazing Meal Replacement" products fail to characterize the level of the nutrient "sugar" in accordance with the regulations. The product labels declare "Sugar Free" on the Principal Display Panel, but fail to provide the required disclaimer statement ("Not a Low Calorie Food," "Not a Reduced Calorie Food," or "Not for Weight Control") as required by 21 CFR 101.60(c)(1)(iii)(B). The disclaimer statement is required because your products do not meet the requirements to bear a "low calorie" claim [see 21 CFR 101.60(b)(2)(i)(B)] and your products do not bear a "reduced calorie" claim or other relative claim of special dietary usefulness [21 CFR 101.60(c)(1)(iii)(A)].

4. The labels for your "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" products bear unauthorized nutrient content claims. Your "Sammi's Best™ Dutch Chocolate. Soy Amazing Meal Replacement" bears the claim, "an excellent source of omega 3 fatty acids" and your "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" bears the claim, "an excellent source of ALA Omega 3 fatty acids." However, the authorized nutrient content claims for omega-3 nutrient in the labeling of conventional foods and dietary supplements, which are based on authoritative statements (See Dockets 2004N-0217, 2005P-0189, and 2006P-0137) as provided for in section 403(r)(2)(G) of the Act, require that the claims identify the specific omega-3 fatty acid, the amount of omega-3 fatty acid in a serving, and the daily value for the specific omega-3 fatty acid. The "an excellent source of omega 3 fatty acids" claim does not meet these requirements. The "an excellent source of ALA Omega 3 fatty acids" claim does not meet the second and third requirements.

5. The labels for your "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" products contain unauthorized health claims. In particular, your product label makes the following unauthorized implied and express health claims, respectively, "Heart Healthy with 24 grams of protein from Soy & Whole Ground Fax [sic] Seeds," and "[a]dequate soy protein may help reduce the chance of heart disease." Although FDA has authorized a health claim for soy protein and reduced risk of coronary heart disease, your product label does not include all of the elements of the claim that are required by the regulation governing the use of this claim [21 CFR 101.82(c)(2)(i)]. In addition, your products do not qualify for this health claim because the products are not low in fat [21 CFR 101.82(c)(2)(iii)(C)].

6. The label for your "Sammie's Best™ Non-Dairy Coffee Creamer" fails to list the food allergen milk. Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as "major food allergens" 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 the exception of highly refined oils. If a food that is not a raw agricultural commodity is, or contains an ingredient that bears or contains, a major food allergen, its labeling must have either:

a. 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 [section 403(w)(1)(A) of the Act, 21 U.S.C. 343(w)(1)(A)]; or

b. The common or usual name of the major food allergen in the list of ingredients followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "sodium caseinate (milk)"), 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)].

7. The label for your "Sammie's Best™ Non-Dairy Coffee Creamer" product contains a false and misleading statement on the information panel, "For your information, Sodium Casseinate [sic] is classified by the FDA as a Non-Dairy or Dairy Free ingredient," Sodium caseinate is a dairy ingredient and FDA has not classified it as "non-dairy" or "dairy-free" [21 CFR 101.4(d)].

8. The label for your "Sammie's Best™ Non-Dairy Coffee Creamer" product characterizes the food as "nondairy" and states that it contains a caseinate ingredient, but it is not declared by its common or usual name. A parenthetical statement identifying its source does not follow the caseinate ingredient. Specifically, it must include a parenthetical term such as "a milk derivative" after the listing of sodium caseinate in the ingredient list [21 CFR 101.4(d)].

9. The label for your "Sammie's Best™ Non-Dairy Coffee Creamer" product bears an unauthorized nutrient content claim ("No Trans Fat") which has not been defined by FDA. We note that you may make a truthful statement on a product's label that specifies the amount of trans fat per serving [21 CFR 101.13(i)].

10. Ingredients required to be declared on the label or labeling of a food must be listed by their common or usual name and without intervening material [21 CFR 101.2(e) and 101.4(a)(1)]. For example, statements such as those made in the ingredient list of your "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" products (such as "Certified Non GMO," referring to the soybean ingredient) are not part of the common or usual name of the ingredient to which they refer; rather, they are considered intervening material and must not be included as part of the ingredient statement. We suggest that you review the labeling of all your products to ensure that their ingredient statements comply with the applicable FDA regulations.

11. The labels of your "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement" and "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" products state: "Many superlatives apply to this amazing dietary supplement." However, these products are labeled as conventional foods rather than as dietary supplements.

12. The following are comments regarding the Nutrition Facts label format as required in 21 CFR 101.9(d) for "Sammi's Best™ Dutch Chocolate Soy Amazing Meal Replacement," "Sammi's Best™ Real Vanilla Soy Amazing Meal Replacement" and "Sammie's Best™ Coffee Creamer:"

o "Calories from Fat" must be declared on the same line with "Calories" rather than below [21 CFR 101.9(d)(5)]. Also, the quantitative amount for "Calories from Fat" is not rounded in accordance with 21 CFR 101.9(c)(1)(ii).

o The heading "% Daily Value*" must be highlighted in bold or extra bold type or other highlighting [21 CFR 101.9(d)(1)(iv)], followed by an asterisk [21 CFR 101.9(d)(6)], and shall be in type size no smaller than 6 point [21 CFR 101.9(d)(1)(iii)].

o A statement of the number of grams of trans fat per serving must be declared un-hyphenated as "Trans Fat," "Trans," "Trans Fat" or "Trans" and must be indented and placed beneath "Saturated Fat" in un-bolded type [21 CFR 101.9(c)(2)(ii)].

o A statement of the number of grams of total carbohydrate per serving must be declared as "Total Carbohydrate" [21 CFR 101.9(c)(6)].

o In the "Sammie's Best™ Coffee Creamer" nutrition label, the percent Daily Value (DV) for Calcium is not rounded in accordance with 21 CFR 101.9(c)(8)(iii).

The above comments are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.

Sincerely,

/S/

Charles M. Breen
District Director

cc: WSDA with disclosure statement