Regulatory

As part of the Food Allergen Labeling and Consumer Protection Act of 2004, FDA was required to finalize labeling rules within four years.

Steve Mister, president and CEO of the Council for Responsible Nutrition, praised FDA for the recent warning letter the agency sent Lazy Cakes, the marketer of melatonin-containing brownies.

Of note, numerous health claims submitted for soy isoflavones were rejected.

Incense Specialities Inc., the brand that markets the melatonin-containing brownie popularly known as “Lazy Cakes” (and since renamed “Lazy Larry”), received an FDA warning letter on July 28.

NPA urges its more than 1900 members to ask their legislators to oppose the legislation by sending them a letter at www.npainfo.org/Durbin.

Among other infractions, the letter charges the company for using milk in its name when in fact the protein shakes contain no milk, as milk is defined by the Code of Federal Regulations.

The company’s Nivea brand inferred that applying its Nivea My Silhouette! topical cream to the skin would result in slimming effects.

NSF International’s NSF Certified for Sport program has certified two joint-health supplements featuring ESM Technologies’ (Carthage, MO) eggshell-derived ingredients.

Notably, the association points out that the bill proposes requirements that are already required under other existing laws.

The agency’s has weighed in on 536 new claims.

European Commission and Canadian authorities have reached an agreement to accept each others' organic product standards as their own-a move which will bolster organic trade between the two countries.

CRN expressed concern over instances in which the agency has rejected NDI notifications, stating that synthetic ingredients cannot qualify as dietary ingredients.

Speakers will include the director of FDA’s division of dietary supplement programs; the head of the global life sciences team at Sidley Austin LLP, which helped draft the Dietary Supplement Health and Education Act of 1994.

The most recent Capitol Hill-based luncheon briefing was filled to capacity with more than 125 people present.

The bill’s announcement comes on the heels of a letter Durbin sent to FDA recently, questioning the agency’s policy on foods containing ingredients such as melatonin.

In particular, the letter expresses the senators’ expectations that the NDI guidance will be in line with the policies enacted by the Dietary Supplement Health and Education Act of 1994 (DHSEA).

The move is intended to help European consumers make healthy food choices.

The San Jose-based botanical extract supplier recently passed a Good Manufacturing Practices (GMP) inspection conducted by SGS.

The agency took issue with specific product claims for products marketed as over-the-counter and homeopathic remedies.

Notably, the rules include guidance on ultraviolet A (UVA) rays, the type of ray linked to skin cancer and early skin aging.

The company adds that the first human clinical trial to evaluate pTeroPure’s effects in patients with lipid, or cholesterol, disorders is underway at the University of Mississippi.

The Silliker certification adds to the GMP certifications the company has also received from NSF International and the Natural Products Association.

The new, minimum font size was proposed by the Council of the European Union.

The European Commission (EC) is not expected to start banning Article 13.1 health claims rejected by the European Food Safety Authority (EFSA; Parma, Italy) before spring of next year-or even summer of next year, says international food policy consultancy EAS.

The products were being distributed by Wyldewood Cellars Inc. (Peck, KS).

The company sought new certification after moving its headquarters in February.

The guidance, Dot Com Disclosures: Information About Online Advertising, was originally published in 2000.

The claim is for reduced risk of atopic dermatitis.