Regulatory
Finding Balance: Dietary Supplement Regulations Versus Consumer Access
Dietary supplements face broader acceptance, along with tighter scrutiny.
Editor's Page: Don’t Be Lazy
Demand and sales for functional food are up. What’s not to love?
Aker’s Superba Krill Oil Now GRAS
The GRAS acceptance follows on heels of recent FDA acknowledgement of a new dietary ingredient (NDI) notification for Superba krill oil.
How Will EU Health Claims Transition Following EFSA?
The European Commission is currently in the process of finalizing its “Union List” of permitted claims, which will be released in December this year.
Wright Group Certified FSSC/ISO 22000
Custom nutrient premix specialist The Wright Group (Crowley, LA) has received Food Safety System Certification 22000.
Should FDA Withdraw Its NDI Draft Guidance?
One law firm has advised that the guidance be withdrawn because its requirements “substantively” deviate from FDA’s original NDI rulemaking.
New Lion’s Mane Extract for Cognitive Health
Amycenone is a standardized extract of two constituents from Lion’s Mane mushroom (Hericium erinaceus), hericenones and amyloban.
Hain Celestial Personal Care Touts NSF/ANSI Organic Standard over USDA’s
It began switching over two years ago because the USDA’s organic-certification program does not provide specific organic standards for personal care products.
PureCircle Welcomes New Codex Stevia Maximum-Use Levels
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.
USANA FDA-Registered as Drug Facility
The company says, raising standards “well above what is required of a dietary supplement manufacturer.”
Senators Press FDA to Finally Establish Gluten-Free Labeling Standards
As part of the Food Allergen Labeling and Consumer Protection Act of 2004, FDA was required to finalize labeling rules within four years.
CRN’s Mister Praises FDA for Lazy Cakes Crackdown
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.
EFSA Publishes Final Batch of Health Claims, Soy Isoflavones Take a Beating
Of note, numerous health claims submitted for soy isoflavones were rejected.
Melatonin Brownie Maker Finally Sees FDA Censure
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 Leads Grassroots Charge Against Durbin Supplements Bill
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.
FTC Warning Letter: Muscle Milk Contains No Milk
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.
Beiersdorf Settles with FTC over Nivea’s “Slimming” Claims
The company’s Nivea brand inferred that applying its Nivea My Silhouette! topical cream to the skin would result in slimming effects.
NSF for Sport Certifies Eggshell Joint-Health Supplements
NSF International’s NSF Certified for Sport program has certified two joint-health supplements featuring ESM Technologies’ (Carthage, MO) eggshell-derived ingredients.
CRN Opposes “Duplicate” Mandates in Durbin’s Proposed Supplements Bill
Notably, the association points out that the bill proposes requirements that are already required under other existing laws.
FDA Releases New Dietary Ingredient Premarket Guidance
Among the sticking points: GRAS ingredients, synthetic ingredients, finished products, changes in manufacturing, and drug ingredients.
EFSA Reviews Fifth Batch of Health Claims
The agency’s has weighed in on 536 new claims.
Canada and Europe Harmonize Organic Markets
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 Challenges FDA’s Take on Synthetic Ingredients in NDI Evaluations
CRN expressed concern over instances in which the agency has rejected NDI notifications, stating that synthetic ingredients cannot qualify as dietary ingredients.
NPA to Host Webcast on FDA’s Forthcoming NDI Guidance
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.
Associations Report Successful Dietary Supplement Caucus on Capitol Hill
The most recent Capitol Hill-based luncheon briefing was filled to capacity with more than 125 people present.
Breaking News: Senator Durbin to Introduce New Dietary Supplement Legislation
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.
Senators Hatch and Harkin Express Support for Impending NDI Guidance
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).
Europe to Harmonize Food-Labeling Rules
The move is intended to help European consumers make healthy food choices.
Draco Passes GMP Inspection
The San Jose-based botanical extract supplier recently passed a Good Manufacturing Practices (GMP) inspection conducted by SGS.
FDA Cracks Down on Zicam Brand Again
The agency took issue with specific product claims for products marketed as over-the-counter and homeopathic remedies.