Enforcement In Brief

CRN proposes DOJ meeting on adulterants

The Council for Responsible Nutrition asks to meet with the Department of Justice to discuss concerns relating to adulterated products marketed as supplements. In a Feb. 24 letter to Attorney General Eric Holder, the trade group says DOJ prosecution of firms selling steroids and other potentially dangerous substances as supplements "would send a powerful message to manufacturers of these illegal products" and help protect public health. CRN points out it is actively engaged with FDA and other industry stakeholders to scrutinize and root out adulterated products (Also see "FDA, Trade Groups Team Up To Bolster Enforcement On Tainted Supplements" - Pink Sheet, 20 Dec, 2010.).

NAD refers Trigosamine ads to FTC

The National Advertising Division refers advertising for Trigosamine Fast Acting joint health dietary supplement to the Federal Trade Commission after an initial case in which the Council of Better Business Bureaus division recommended marketer PatentHEALTH discontinue claims that the product "works" or "gets results" in three days. Since the initial review, recently published ads for the product "make substantially the same claims in substantially the same manner," and the self-regulatory process has been "exhausted," NAD says.

In July 2010, NAD recommended the firm discontinue the rapid relief claims because the study the claims relied upon was insufficient. PatentHEALTH agreed to discontinue certain claims, but appealed aspects of the decision to CBBB's National Advertising Review Board, specifically that the firm make advertorials appear more like ads and less like news articles. However, NARB upheld the watchdog group's decision ("NARB Panel Confirms Recommendations To PatentHEALTH," "The Tan Sheet" Feb. 8, 2010, In Brief).

Some Somnapure sleep claims supported

NAD finds the Peak Life brand's Somnapure melatonin-containing supplement has a reasonable basis for making claims about the sleep benefits of ingredients including melatonin, valerian extract and chamomile flower extract. However, HFM Marketing positioned Somnapure as akin to a sleeping pill when its ingredients are more effective when taken regularly, NAD said March 17. Based on the division's recommendations to clarify the ingredient claims and make the supplement website more transparently an advertisement, HFM/Peak Life said it would make adjustments.

FDA warns against "fortified" candy

Goetze's Candy Co. is not permitted to claim its Caramel Creams Double Chocolate product is "fortified with calcium" because snack foods, such as candy, cannot make nutrient content claims, FDA says March 4. The agency's warning letter gives Baltimore-based Goetze's 15 working days to correct a slate of labeling issues, including serving size and flavor characterization violations.

Stem cell topical products pegged as drugs

A March 1 FDA warning letter says StemCellin Intensive Emulsion, StemCellin Deep Wrinkle Serum and Faitoz-25 by JabaLabs feature label claims that cause the anti-aging products to be drugs. Ingredients in the products, including hyaluronic acid, rosehip seed oil and vitamin E, are claimed to "promote collagen production while strengthening the essential structure of skin tissue" or reverse “chronological aging." FDA says the San Antonio-based company's products are not generally recognized as safe and effective for the structure/function claims they make.

Herbals make therapeutic claims

Online retailer Herbal-supplements-for-you makes therapeutic claims including lowering blood sugar, inhibiting HIV and treating diabetes for its Karela, Lasuna, Shallaki and Triphala products, FDA says. A Dec. 2, 2010, warning letter says the agency's October review of the firm's website found claims in violation of the Food, Drug & Cosmetic Act because they are for the cure, mitigation, treatment, or prevention of disease. The letter from the Center for Food Safety and Applied Nutrition's Office of Compliance also notes the firm's herbals are considered new drugs because they are not approved for the indications the claims make. Further, the herbals are mislabeled because their labeling does not include adequate directions for the intended uses, according to the letter submitted via e-mail, but not to a physical address.

(Editor's note: In addition to warnings on noncompliant claims for dietary supplements, FDA has submitted warnings about good manufacturing practices violations to supplement firms. See (Also see "FDA Sending Steady Stream Of Supplement GMP Warnings In 2011" - Pink Sheet, 21 Mar, 2011.) p. 13.)