Regulatory

What's the NDI (New Dietary Ingredient) Notification Process Really Like?

IASC alleges that Fruit of the Earth continued to use IASC’s third-party certification seal even after IASC withdrew certification rights.

EAS says that the proposal states that human data should be used to substantiate health claims unless it is not possible due to test method limitations.

Article 13.1 claims evaluations should not be finalised until a framework is in place to assess the totality of the evidence, European trade association EHPM has said.

For weight management, ingredient suppliers are talking satiety. Which ingredients fit the bill?

What can’t you say about a dietary supplement? For one, you can’t say that it works, even if it works, until FDA says you can say it works.

In addition to staying mindful of regulations, manufacturers need to decide which side of the generational divide they are targeting if anti-energy products are to amount to anything more than a fragmented niche.

Six new strains of Escherichia coli will be barred from raw meat sold on the U.S. market.

The deadline is now December 2.

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 GRAS acceptance follows on heels of recent FDA acknowledgement of a new dietary ingredient (NDI) notification for Superba krill oil.

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One law firm has advised that the guidance be withdrawn because its requirements “substantively” deviate from FDA’s original NDI rulemaking.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