Regulatory

In a letter to FDA, Jarrow L. Rogovin asks that Daniel Fabricant, PhD, be removed from his post as director of FDA’s Division of Dietary Supplement Programs and for FDA to extend the NDI guidance comment period by a year.

The event will take place Thursday, September 8, 2011, in downtown Chicago.

The inspection was performed by SGS, which also performed the supplier’s ISO 9001:2000 and HACCP certifications.

Notably, FDA disagreed with complaints that the agency has underestimated the time and cost required for filing NDI notifications.

AlaskOmega is a product of Organic Technologies (Coshocton, OH).

The company is also USDA certified organic and kosher certified by Star-K.

Is FDA regulating NDIs like GRAS substances and food additives?

Dietary supplements face broader acceptance, along with tighter scrutiny.

Demand and sales for functional food are up. What’s not to love?

The European Commission is currently in the process of finalizing its “Union List” of permitted claims, which will be released in December this year.

Custom nutrient premix specialist The Wright Group (Crowley, LA) has received Food Safety System Certification 22000.

One law firm has advised that the guidance be withdrawn because its requirements “substantively” deviate from FDA’s original NDI rulemaking.

Amycenone is a standardized extract of two constituents from Lion’s Mane mushroom (Hericium erinaceus), hericenones and amyloban.

It began switching over two years ago because the USDA’s organic-certification program does not provide specific organic standards for personal care products.

At a Codex meeting in early July, the Codex commission accepted the proposal by the Codex Committee on Food Additives (CCFA) to define such levels.

The company says, raising standards “well above what is required of a dietary supplement manufacturer.”

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.

Among the sticking points: GRAS ingredients, synthetic ingredients, finished products, changes in manufacturing, and drug ingredients.

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.