Regulatory Compliance Insights: 2018 REJIMUS Industry Publications

REJIMUS Publications 2018

Healthy aging claims: Time is the ultimate regulator
December 27, 2018
For anti-aging products, the target of the claim must be clear, the action of the claim must be carefully selected and substantiation is mandatory.
Ingredient transparency beyond legal requirements
December 17, 2018
Transparency of ingredient sources isn’t required by law, but brands should ask their contract manufacturers for this information.
Adulteration and claims in curcumin
December 7, 2018
Curcumin ingredient suppliers have addressed bioavailability issues by creating standardized extracts, but brands must focus on adulteration and claim issues, as well.
Regulatory hurdles for probiotics
November 27, 2018
Probiotic brands must be careful when labeling the quantity of microorganisms in products as well as claims involving their benefits.
US federal government stays steady despite administration
November 19, 2018
The health and nutrition industry expected the Donald Trump administration to roll back regulations, but so far, it’s been business as usual.
Claims for joint health—Structure first
November 13, 2018
Joint health marketing claims should focus on the structural benefits substantiated by studies with healthy populations, and these legal messages should be reflected in the overall labelling of the product.
Claims for joint health—Structure first
November 1, 2018
Joint health marketing claims should focus on the structural benefits substantiated by studies with healthy populations, and these legal messages should be reflected in the overall labelling of the product.
Auditing a contract manufacturer: Essential for both parties
October 26, 2018
A good contract manufacturer appreciates efficient and frequent audits.
Claims considerations for adaptogens for sleep, stress
September 21, 2018
Adaptogens are increasingly recognized for their effects on sleep and stress, but does the use of these compounds meet regulatory requirements?
Compliance: is your new product a food or supplement?
August 21, 2018
When deciding whether a new product will launch as a food or supplement, four regulatory areas to consider are identification, manufacturing, claims and composition.
Legal Healthy Aging Marketing Claims
July 11, 2018
Aging is a natural process that all face; it is not a disease, yet in FDA’s thinking, products that talk about addressing the aging process are making disease claims.
Legally Marketing Immune Health Products
June 28, 2018
Immune health claims can be tricky for natural product brands to make because they intend to address the body’s ability to stay well, which implies disease prevention.
Meeting Contractual Obligations With Quality Agreements
June 19, 2018
Supplement brands should rely on quality agreements with their contract manufacturers to ensure regulatory requirements are met.
Three Supplement Testing Requirements and Their Challenges
May 14, 2018
The three primary testing requirements from a regulatory standpoint include testing against established specifications; using scientifically valid, analytical methods; and testing every batch of components, in-process materials and finished goods.
Regulatory Enforcement in Contract Manufacturing: An Emerging Normal
May 1, 2018
With new authority from the Food Safety Modernization Act (FSMA), FDA is acting more to remove noncompliant supplement products from the market.
Industry and Regulatory Bodies Collaborate with Adversarial Respect
March 20, 2018
Careful word choice for industry interaction with regulatory agencies reflects relationship, defines approaches to be used and insists on respect.
Modern-Day Laws for Traditional Ayurvedic Botanicals
February 28, 2018
Ayurveda comes to U.S. markets with thousands of years of history, but products using these types of botanicals must also follow modern-day laws.