In the three decades since landmark legislation framed the marketplace, dietary supplements have proliferated, offering consumers an expanding menu of products.
The voluntary set of industry guidelines calls for the immediate disposal of “irreparably defective” botanical raw materials, ingredients, or products.
Nkrumah-Elie, global director for external research at ChromaDex, was honored for her commitment to advancing science, diversity, and female leadership.
Without more resources, FDA can’t conduct enough inspections to get an accurate picture of the marketplace, highlighting the importance of self-regulation.
Two patented botanical extracts were associated with significant increases in GLP-1 blood levels and significant weight loss in 90 overweight/obese subjects.
This versatile ingredient has been clinically studied for safety, quality, and stability, offering manufacturers an efficacious product with reliable supply.
At the 12th annual Legal, Regulatory, and Compliance Forum on Dietary Supplements, FDA and FTC officials, and lawyers discussed a grab bag of hot topics.
The bitter hops extract, which is associated with GLP-1 activation, has now been subject to three studies examining its potential in appetite reduction.
Collagen, pet nutrition, sports nutrition, beauty-from-within, and biotics products will see the biggest shake-ups in the coming year, the company projects.
Learn about HMB’s benefits for muscle strength, market insights, and supplement formulation. This leucine metabolite is key for muscle health and performance.
While the studies await publication, new findings examined aged garlic extract in cystic fibrosis, aerobic fitness, cognition, circulation, and oral health.
The range of symptoms and health needs experienced by women at this life stage represents one of the most important white spaces in today’s marketplace.
The magnesium chelate, capable of crossing the blood-brain barrier, has an influence on the organization and strength of synaptic connections between neurons.
The nonprofit group works with over 1,200 local organizations and governments to reach more than 72 million women and children in 65 countries each year.
Our most-viewed stories in April included coverage of Amazon's new policy for dietary supplement sellers, Goli's acquisition, the beauty market, and more.
Can the agency better ensure product quality and safety without adding costs, stifling innovation, and constraining access to potentially beneficial products?
A new House bill would amend the Food, Drug, and Cosmetic Act to grant FDA more authority against products that don't meet the definition of dietary supplement.
In addition to stricter testing requirements, all certificates of authenticity must come directly from third-party companies partnered with the retailer.
With a sizable portion of U.S. consumers taking new weight loss drugs, experts discussed ramifications for marketers, brands, and healthcare practitioners.
The latest of what will be several guidance documents on the NDI process provides updates on the agency’s proposed method to handle proprietary information.
For elite athletes, active lifestylers, and those in the golden years, the supplement market offers compelling options to support strength and mobility.
Ginseng’s active compounds can stimulate the central nervous system, reduce inflammation and oxidative stress, and regulate cortisol, according to authors.
Our most-viewed stories in January included Amazon's warning letter from FDA, economically-motivated adulteration in botanicals, and supplement trends to watch.
An analysis co-authored by STRIPED's director estimated the prevalence of “diet pill,” laxative, and diuretic use across adolescent populations in 90 studies.
Qualia Senolytic, a nine-ingredient formula designed to support the body in eliminating senescent cells, improved self-reported joint function within six months
The Spilanthes acmella extract was associated with significant increases in mean testosterone levels, muscle mass, and self-reported sexual satisfaction.
The coalition of CBD stakeholders plans to advocate for CBD to be regulated as a dietary ingredient with a set of unique testing and labeling standards.
Due to “competing priorities,” the agency provided no clarification on how it interprets the provision of DSHEA which defines drugs versus dietary ingredients.
The study conducted by MDbio in partnership with Radicle Science found improvements in measure of sleep, stress, and anxiety in a population of 620 adults.
During fermentation, microorganisms engage with the berry substrate, resulting in diverse chemical transformation that yields heightened polyphenol content.
FDA’s expanded enforcement authority, combined with new statutory and regulatory requirements, will lead to added scrutiny of cosmetics ingredients and claims.
By Todd Harrison and Melanie English, Venable LLP10.16.23
Convenient product formats like gummies and beverages offer broad appeal, while multifunctional dietary supplement formulas offer value for varied need states.
Vitaquest International's new facility comes with fluidized bed process technologies enabling particle and powder engineering for foods and dietary supplements.
The new multi-ingredient product by Touchstone Essentials contains a plant-based enzyme evidenced to convert glucose molecules from food into resistant starch.
Following an update from the agency, the trade association characterized the agency’s plan as ‘pulling back’ on its responsibility to regulate supplements.
BioPerine® has been widely used to enhance the bioavailability of several dietary supplement ingredients and requires a very low dosage of 5mg per serving.
The Founder & Executive Director of the American Botanical Council reflects on nearly 50 years of industry experience and the advancement of ABC's mission.
MoCRA expands FDA’s authority over cosmetics with requirements for safety substantiation, adverse event reporting, facility registration, and product listing.
By Evelina J. Norwinski, Elizabeth Trentacost, and Ryan D. White, Arnold & Porter04.13.23
A bill which offered a slate of protections for people with eating disorders was amended in order to remove dietary supplement restrictions from the equation.
RFI’s proprietary FermaPro solution can ferment any dry material—grains, grasses, seeds, botanicals, vegetables, and fruits—using bacterial or yeast cultures.
President and CEO of the Council of Responsible Nutrition discussed the industry’s need to strengthen communications, self-regulation, and transparency.
GABA, Apocynum venetum, and glycine have different mechanisms of action, which is important when creating a formula that addresses multiple sleep issues.
By Gene Bruno, MS, MHS, RH(AHG), VP, Scientific and Regulatory Affairs, NutraScience Labs09.20.22
Morus alba has a long history of safe use in TCM, and the evidence implicating this herb with the death of a Congressman’s wife is inconclusive at best.
Proposed legislation aims to create a new agency that would assume responsibilities for the regulation of food and dietary supplements currently held by FDA.
By Michael McGuffin, President, American Herbal Products Association (AHPA)09.13.22
According to product recall reports, just a portion of products containing illegal ingredients were recalled following the issuance of warning letters.
With consumers prioritizing clean label appeal, producers are met with new opportunities to provide products that promote closer-to-nature ingredients.
A review of 71 studies found a dose-dependent relationship between omega-3s and blood pressure reductions, most significant for those with hypertension.
China’s supplement market is growing at double digit levels. Jeff Crowther has the market intel to assist companies in capitalizing on emerging opportunities.
If a claim describes the substantiated role a nutrient or dietary ingredient plays in the body, plaintiffs cannot survive a motion for summary judgment.
By Todd Harrison, Partner; Richard Starr, Associate; and Olisa Onyiuke, Associate, Venable06.02.22
With fewer recalls than conventional foods, drugs, animal products and medical devices, supplements could be considered the safest class of goods FDA regulates.
By Michael McGuffin, President, American Herbal Products Association (AHPA)06.02.22
Amnesty for late NDI notifications is intended to encourage manufacturers and distributors to correct past failures while collecting safety data, FDA said.
The new Master’s degree program will equip working professionals with regulatory compliance and nutrition guidelines relevant to the supplements industry.
Gummies, beverages, stick packs, and snack-like products are on-trend, but brands have a lot to consider in terms of formulation and regulatory compliance.
Industry should view both proposed legislation and arguments against it with a critical eye, but let’s address legitimate concerns while dismissing strawmen.
By Steve Mister, President & CEO, Council for Responsible Nutrition04.26.22
Sen. Dick Durbin (D-IL) and Sen. Mike Braun (R-IN) introduced a bill that would require dietary supplement manufacturers to file product information with FDA.
Utah’s longest-serving Senator was known for working across the aisle, authoring or coauthoring some of the most consequential laws of the past half century.
Plaintiffs are monitoring whether a company abides by all relevant FDA regulations, so it’s important to understand requirements and confirm disclaimers.
By Todd Harrison, Partner; Kristen Klesh, Counsel; Olisa Onyiuke, Associate; and Melanie English, Associate Venable04.14.22
Technology that can track a sequence of transactions helps build trust among stakeholders along the supply chain, as well as between consumers and brands.
By Robert Galaza, CEO, TruTrace Technologies04.14.22
The U.S. Food and Drug Administration is prioritizing multiple ways to regulate the dietary supplements industry in its request for an $8.4 billion budget.
Trial finds modest reduction in cardiovascular events for those taking cocoa extract, no association between multivitamins and reduced risk of cancer or CVD.
Two pre-clinical studies and a human clinical trial shed light on the herbal combination’s ability to curb adipogenesis and increase resting energy expenditure.
The agency has called into question the amino acid metabolite’s legal status as a dietary ingredient, counter to the opinions of several industry leaders.
Based on NHANES data collected from cancer survivors, the authors of a review found that the use of supplements was linked to long-term, cost-effective benefit.
After issuing warning letters to companies claiming that NAC is excluded as a dietary ingredient, the agency's response to citizen petitions is still tentative.
Defining standard terminology is important to the hemp and CBD industries for regulations, consumer understanding, and product manufacturing and marketing.
Company specializes in analytical chemistry and microbiology testing for pharma, nutraceutical, dietary supplement, cosmetic, and cannabis/CBD industries.
The company’s Lustriva has been shown to increase hair growth in as little as three weeks, reduce facial wrinkles, fine lines, and improve skin texture.
Updates were designed to make it easier to navigate the database through more streamlined search functions with the ability to customize search results.
Euglena gracilie from Solabia-Algatech Nutrition produced through fermentation technology to deliver high beta-glucan plus protein, vitamins, minerals and more.
FDA raised objections to the use of N-acetylcysteine in supplements in Dec. 2020, and since, Amazon has pulled all NAC-containing products from its platform.
Focus centered around the GRAS and NDI processes, the prospects of a mandatory product listing, how health claims will be handled in the future, and more.
At the global nutraceutical event, speakers covered the latest evolutions in the often-intertwined nutrition categories of immune and digestive support.
The bipartisan legislation, the Hemp Access and Consumer Safety Act of 2021, was introduced by Senators Ron Wyden, Jeff Merkley (both D-OR) and Rand Paul (R-KY)
The Botanical Adulterants Prevention Program’s latest installation includes lab data from 532 commercial elderberry samples, evidencing authenticity problems.
Promotions include Holly Vogtman to director of communications, Rashidah Denton to manager of scientific and regulatory affairs, and Gretchen Powers’ expanded role to include member experience.
BAPP publications include research and education to allow industry members to set ingredient specifications, authenticate ingredients, and assess adulterated materials in the supply chain.
While the agency has not specifically confirmed it, dietary supplements were not mentioned in a list of manufacturers required to enhance traceability measures.
The firm specializes in representing food, beverage, and dietary supplement companies in supply chain, intellectual property, and other business disputes.
With different biological mechanisms, these two omega-3 fatty acids have unique roles to play in sleep quality, efficiency, and subjective feelings of rest.
The third-party testing organization will also expand its dietary supplement GMP program to include manufacturers of cosmetics, personal care, and over-the-counter products.
Ridley’s responsibilities will be to spearhead the association’s communications program, build key partnerships, and craft education and advocacy campaigns.
FDA currently prohibits the use of NAC as a dietary supplement, and is concerned about a proposal for HHS to review certain regulations or let them expire.
Some practitioners were not selling or promoting products, they were simply suggesting certain natural substances might offer benefits in improving resilience.
With support from clinical findings and increased consumer demand, elderberry is a top ingredient in the dietary supplement and natural products industry.
By Melanie Bush, Director of Science, Artemis International, Inc.10.01.20