The Federal Trade Commission's ongoing crackdown on "bogus" health claims leads to a $2.1 million settlement with NBTY and two subsidiaries to resolve charges they overstated the amount and benefit of DHA in children's multivitamins.

The agreement announced Dec. 13 comes almost a year after FTC warned 11 unnamed marketers of children's omega-3 fatty acid supplements that it might take enforcement action if they could not substantiate claims their products enhanced the intelligence, mood and visual acuity of children older than 2 years.

While NBTY said it was not among the warned firms, the commission says the firm and its subsidiaries NatureSmart and Rexall Sundown misled consumers to believe their line of Disney- and Marvel Heroes-licensed children's multivitamin gummies and tablets contained 100 mg of docosahexaenoic fatty acid and that amount promoted healthy brain and eye development in children aged 2 years and older, according to the complaint.

Other FTC 'Bogus Health Claims' Cases

Other firms caught in FTC's crackdown include:

The Dannon Co., which paid $21 million to resolve allegations it overstated the health benefits of Activia yogurt and DanActive dairy drink. FTC announced the settlement Dec. 15.
Nestle HealthCare Nutrition agreed to drop claims BOOST Kid Essentials prevents upper respiratory tract infections, children's sick days and duration of acute diarrhea in a settlement announced July 14.
POM Wonderful faced an FTC complaint that POM Wonderful 100% Pomegranate Juice and POMx supplements can prevent heart disease, prostate cancer and erectile dysfunction, the commission announced Sept. 27.
Iovate Health Sciences USA and two Canadian affiliates paid $5.5 million to settle allegations they falsely advertised Accelis, nanoSLIM, Cold MD, Germ MD and Allergy MD could help consumers lose weight or prevent colds and other illness, FTC announced July 14.

However, FTC said, a daily serving of the NBTY products contained either 100 mcg of DHA – which is one-thousandth of 100 mg – or as little as 50 mcg.

The firms stated "with DHA*" in white font on a red starburst graphic on print ads with a claim at the bottom of the advertisement stating, "DHA is naturally found in the brain and the eyes. 100 mg promotes healthy brain and eye development. One serving provides 100 mcg of DHA," according to the complaint. Similar claims appeared on packaging.

FTC argues these claims by the top U.S. vitamin and supplement manufacturer suggest the products contain an amount of DHA comparable to 100 mg.

The commission also argues NBTY, NatureSmart and Rexall Sundown could not prove the actual amount of DHA in the products promote healthy brain and eye development in children.

NBTY told "The Tan Sheet" that the resolution "reaffirms our commitment to labeling transparency and adherence to the highest standards of regulatory compliance. It also allows us to continue to focus on providing high-quality nutritional supplements."

The settlement may be a harbinger of more to come.

When FTC warned firms in February 2010 to substantiate omega-3 health claims, it indicated its probe was not complete and that it might send additional warning letters (Also see "Omega-3 Probe Underscores FTC Standard For Claims Substantiation" - Pink Sheet, 22 February, 2010.).

Of the 11 original firms, FTC said at the time several changed the claims or removed the products from store shelves, but that it continued to work with some firms.

The commission said it wanted human clinical cause and effect studies of the age group for which the product is intended.

FTC's interest in omega-3 claims for children's products stemmed from its investigation into questionable claims by Northwest Natural Products that L'il Critters Omega-3 Gummy Fish could boost brain function, development and academic achievement, the commission said.

This is not NBTY's first settlement with FTC about allegations the firm misled supplement consumers.

It paid a $2 million fine in 2005 for violating an earlier false claims settlement when its subsidiary Dynamic Essentials said Royal Tongan Limu fights a number of different diseases and increases longevity (Also see "NBTY Settles Suit For $2 Million; FTC Says Firm Broke Prior Agreement" - Pink Sheet, 17 October, 2005.).

Unlike then, the most recent settlement does not include civil penalties, but the settlement notes the violations could subject the company to future fines.

Rather, the $2.1 million in this settlement will refund consumers who purchased Disney and Marvel Heroes children's multivitamins for about $4 to $8 for a 60-count bottle, according to the FTC.

The settlement also bars NBTY from misrepresenting the amount of any ingredient in its products and promoting ingredients as helping brain or eye health unless it can support the claims.

The Carlyle Group investment firm acquired Ronkonkoma, N.Y.-based NBTY in a $4 billion leveraged buyout in October and has replaced long-time CEO Scott Rudolph, the son of company founder Arthur Rudolph, with Jeffrey Nagel (Also see "NBTY Appoints GE Vet To Succeed CEO Rudolph" - Pink Sheet, 13 December, 2010.).

By Elizabeth Crawford

NBTY Agrees To $2.1M Settlement With FTC For False DHA Claims

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