2019 Regulatory Compliance Insights and Industry Publications

REJIMUS July newsletter banner highlighting regulatory compliance and industry updates.

REJIMUS Publications 2019

Be specific with your formula
December 24, 2019
Consideration of each specification in a supplement requires the documentation of each critical aspect of the finished product.
Shelf life requirements for probiotic products
December 11, 2019
Probiotics in shelf-stable foods must test to ensure microorganism viability until the end of shelf life.
Good (not perfect) manufacturing practices
December 6, 2019
Standards for supplement good manufacturing practices are being enforced to an ever-deepening degree of detail, and the industry needs to prepare for greater scrutiny.
FDA’s limited view of inflammatory claims
October 25, 2019
FDA says general inflammation claims from supplements and foods are illegal because chronic inflammation is a disease state.
Applying the ‘E’ for joint health
October 7, 2019
Emphasizing education and pushing the bounds of structure/function claims may offer joint health marketers a new path forward.
GMP standards evolve for supplement manufacturers
September 24, 2019
The next rounds of GMP inspections from FDA will seek more raw data and expect that manufacturers demonstration continual operational improvements.
Considering claims for menopause support
July 9, 2019
FDA recognizes the boundaries between dysfunctional states and life stages and, in fact, it may be argued that FDA grants greater leeway in this consideration toward women.
Aging is not always healthy
August 19, 2019
Healthy aging consumers are either looking to grow older with their health intact or are looking to address concerns that arise in later life years; both need substantiated, truthful information on product benefits.
Brands must play by the rules to be good sports in the nutrition industry
July 3, 2019
Sports nutrition, by virtue of its products, presentations and desired outcomes, blends every challenge faced by the greater health and nutrition industry.
Immune health claims substantiation
June 18, 2019
FDA’s requirements for claims substantiation can hinder brands attempting to make immune health claims.
Premix regulatory challenges
June 13, 2019
The use of premixes in dietary supplement contract manufacturing requires disclosures, quality and a shared responsibility of compliance.
FDA GMP compliance demands
April 29, 2019
FDA is diving deeper in GMP (good manufacturing practice) requirements and asking for more details during its site inspections.
FDA’s thinking on dietary ingredient status could hinder biotechnology advancements
April 3, 2019
FDA has said that synthetic materials are not considered dietary ingredients and are thus not legal to use in supplements, but biotechnology promises a new way to manufacturer ingredients.
Botanical must be in food, not medicine, for ‘historical use’ safety justification
March 25, 2019
Botanical ingredients in traditional medicines do not count as a historical use to justify safety in U.S. supplements and foods.
Don’t take it personally—Regulations are the same for everyone
March 7, 2019
Personalized nutrition products must follow the same laws as products for the general population, but the tailored approach brings regulatory challenges.
A brand’s best face forward
February 7, 2019
Packaging should protect the product and attract consumers’ attention while allowing for compliance with the regulatory mandates.
CBD concentration matters
January 30, 2019
Supplement brands should ensure their CBD products have appropriate claims and don’t overemphasize the CBD concentration.
Narrowing of heart health claims
January 4, 2019
The realm for cardiovascular health claims within the dietary supplement Industry is much narrower than it legally ought to be, and this is the real heart of the matter.