Regulatory News In Brief

FDA warns Synticare for AREDS product claims; disease metatags inappropriate for supplement sales sites; FDA holds Birkdale accountable for testimonials; ebA multivitamin recalled for undeclared milk; more Regulatory News In Brief.

FDA warns Synticare for AREDS claims

Dietary supplement marketing with references to scientific studies could trigger an FDA warning letter if the studies mention disease states, FDA says. Synticare Corp. learned this after it included on its webpage links to online summaries of the National Institutes of Health-sponsored Age-Related Eye Disease studies examining macular degeneration, according to a warning letter FDA sent to the Sedona, Ariz., firm March 15. The agency said by claiming its supplements included the same ingredients as those used in the studies, the firm made a disease claim. FDA also says Synticare directly claimed its AREDS 1, AREDS 1 Smokers and AREDS 2 products helped prevent treatment of macular degeneration, making them unapproved new drugs. As of April 25 the links referenced in the letter remained on the firm’s website, as did claims that the supplements could slow macular degeneration.

Disease metatags inappropriate for supplements

Internet search metatags for dietary supplement sales websites that reference diseases indicate the supplements are intended to treat, cure, mitigate or prevent disease, rendering the products unapproved new drugs, FDA says. According to a Nov. 5, 2012, warning letter to Andrew Jones, a physician operating the Women’s Health Institute of Texas, several of Jones’ websites promoted products marketed as supplements with claims that made them unapproved new drugs. Digest+SEB was promoted as a “first line treatment for Irritable Bowel Syndrome,” Iodine Plus 2 as a treatment for thyroid-deficient conditions and the website for D5000 (Vitamin D) included claims linking vitamin D deficiency with cancer, flu, heart failure and other ailments, according to the letter posted on FDA’s website April 23.

FDA holds Birkdale accountable for testimonials

FDA shows in a warning letter sent March 20 to Birkdale Medicinals LLC that the agency holds firms accountable for personal testimonials that make disease claims for supplements. FDA explains that a testimonial on the firm’s website for Immune Response 247 makes the product a drug because it is a disease claim attributing a significant drop in cholesterol triglycerides to using the product. As of April 25, the testimonial was still on the firm’s website. An email to the company was not returned. The agency pointed out other disease claims on the website such as claims Cholestat reduces inflammation and helps control cholesterol build-up, Silymarin 81 treats liver ailments and LevelStat helps maintain normal blood sugar.

ebA Multivitamin recalled

A report that a consumer suffered an anaphylactic reaction to the ebA Multivitamin Supplement prompts Saratoga Therapeutics LLC to recall 900 bottles of the product after testing revealed undeclared milk components. The North Wales, Pa., firm announced April 23 that a second consumer with a milk allergy reported being “sick” after taking ebA. The recalled lots #0912164, with expiration date 12/12, and #1110354, expiration date 10/14, were distributed in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland and Tasmania, according to the firm.

Omega Pharma substantiates U.K. weight loss claim

Omega Pharma Ltd. sufficiently substantiates claims XLS-Medical could help users lose up to three times more weight, and did not make predictions about specific weight loss, the U.K. Advertising Standards Authority says in an April 17 report. The firm provided “a robust” double-blind, placebo-controlled trial that showed after 12 weeks obese subjects who took two tablets of XLS-Medical three times a day and maintained a calorie-reducing diet lost 3.97 times more weight than those in the placebo group. ASA added that because the advertisement qualified the specific weight loss amount with the phrase “a study has shown,” it made clear the results were not predictions consumers could expect. Likewise, ASA said the ad clearly indicates proper diet and exercise are necessary for weight loss with use of XLS-Medical. The International Association for the Study of Obesity and two other parties brought the complaint.

No wheatgrass disease claim in U.K.

The U.K. Advertising Standards Authority tells online retailer Big Juice Ltd. that the British firm cannot make health claims and reduction of disease risk claims for wheatgrass juice such as, "cleanses the colon,” “washes drug deposits from the body,” and "promotes regularity.” ASA said in an April 17 report that a scientist challenged the claims, but Big Juice did not respond to the agency’s requests for substantiation. Health claims and reduction of disease risk claims are only acceptable if listed as authorized in the European Union’s register of nutrition and health claims; ASA said Big Juice’s claims were not listed.