FDA: Salba Uses Drug, Unauthorized Nutrient Claims

MAITLAND, Fla.FDA warned Natural Guidance that it made drug claims about it Salba products on its websites, used unauthorized nutrient-content claims on its websites and failed to register its facility, according to a letter the agency send to owner Mitchell A. Propster.

Drug Claims

FDA said it reviewed NaturalGuidance.com and Salba.com as recently as July 2011, and determined Salba® brand products 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 [21 U.S.C. § 321(g)(1)(B)] because claims say the products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. 

FDA called out the specific claims:

Check out this INSIDER slide show for more on the legal use of testimonials and endorsements.

Nutrient-Content Claims

FDA also said labeling  on various Salba products includes unauthorized nutrient content claims in violation of under section 403 of the Act [21 U.S.C. 343]. FDA said NaturalGuidance.com includes claims for specific nutrients even though the food does not contain 20 percent or more of the daily value per reference amount customarily consumed (RACC). Per 21 CFR 101.54(b)(1), nutrient content claims that use the defined terms rich in," high," or excellent source of" may be used in the labeling of a food only if the food contains 20 percent or more of the daily value of that nutrient per RACC. The website says Salba Whole Food Bars (Tropical Fruit, Cranberry Nut, and Mixed Berry) are [R]ichest sources of magnesium, calcium, iron "

Nutrient content claims for alpha linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) omega-3 fatty acids require claims to specify whether the claim is referring to ALA, DHA or EPA omega-3 fatty acids, which FDA said Natural Guidance does not do on its websites. According to FDA, Salba.com said Salba Seed Oil (12 oz.) and Salba Seed Oil Softgels (90 ct.) are [N]atures richest source of Omega-3s" and Salba Whole Food Bars (Tropical Fruit Cranberry Nut, and Mixed Berry) are, nature's richest plant-based source of Omega-3s" The agency said NaturalGuidance.com said Salba is nature's richest vegetarian source of omega-3s" and Salba Ground Seed - 9.5 oz. and Salba Whole Seed Super-Grain 16 oz. are the Richest Source of Omega-3s in Nature."

Additionally, FDA took issue with Natural Guidances use of the term antioxidant." 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, an RDI must have been established for each of the nutrients that are the subject of the claim, and these nutrients must have recognized antioxidant activity. 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).  Such a claim must also 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).

However, FDA said the Natural Guidances websites include antioxidant claims" that fail to include the names of the nutrients that are the subject of the claim nor do they provide the names of the nutrients with recognized antioxidant activity. Such examples include  Salba Whole Seed Super-Grain 16 oz. and Salba Whole Food Bars (Cranberry Nut, Mixed Berry, Tropical Fruit): 30% More Antioxidants than Blueberries" on NaturalGuidance.com, and Salba Ground Seed 9.5 oz.: With an arsenal of quality nutrients Magnesium, Protein, Calcium, Antioxidants, Potassium, Iron, and Folate " on Salba.com

Facility Registration

Lastly, FDA said the companys facilities are not registered per Section 415 of the act [21 U.S.C. § 350d] and 21 CFR Part 1, Subpart H. FDA said records indicate that, to date, its facility, Natural Guidance LLC, has not been registered with FDA, and that it failed to update and revise the registration from your previous business, Core Naturals LLC, to Ancient Naturals LLC. FDA noted the company can register online at Access.FDA.gov, which provides an automatic confirmation of registration and automatic issuance of a registration number.

FDA gave the company 15 working days from receipt of the warning letter, and said the companys response should outline the specific steps it is taking to correct the violations. The response should include documentation and any other useful information that would assist FDA in evaluating the corrections.