Gradient

Dietary Supplements

Overview
Example Projects
Experts

Overview

Manufacturers and distributors of dietary supplements are responsible for both documenting evidence of safety and effectiveness of their products, as well as for health claims used in advertising. Meeting these responsibilities is becoming increasingly complex, and manufacturers face more obstacles than ever before. Impediments to successful product development and marketing include product adulteration issues, challenges by US FTC and US FDA regarding health claim accuracy, Good Manufacturing Practice enforcement, and the ever-changing regulatory climate.

Gradient has the expertise to help manufacturers and distributors meet these challenges. In addition to more than 25 years of experience in toxicology, chemistry, risk assessment, and information sciences, Gradient staff are experts in regulatory comment, safety assessments, Generally Recognized as Safe (GRAS) evaluations, study design and oversight, as well as product purity and adulteration issues.

Example Publication

Wait, AD. 2010. "Data quality and transparency in the dietary supplement industry." Food Drug Law J. 65:471-487.

Dietary Supplement

Example Projects

GRAS Determination of the Safety of Caffeine

Full Description

Gradient evaluated the safety of caffeine in an energy drink in a manner consistent with a Generally Recognized as Safe (GRAS) determination. We researched current caffeine consumption, quantified added consumption from energy drinks, reviewed key toxicity studies, and conducted a detailed quantitative analysis. We set up a GRAS panel, which conducted an in-depth evaluation as to whether caffeine is safe under the conditions of its intended use in an energy drink.

Safety Evaluation for a Pesticide in Dietary Supplements

Full Description

Gradient assessed the toxicity and risks of tau-fluvalinate, a miticide sometimes found in beeswax that is used as an emulsifier in dietary supplements. Gradient evaluated whether the tau-fluvalinate in the supplements would result in any adverse health effects by calculating the amount of tau-fluvalinate a person might ingest and comparing it to US and European toxicity criteria.

Product Adulteration of a Dietary Supplement

Full Description

Gradient designed and conducted a forensic testing program to determine the presence and source of anabolic steroids alleged to be present in a dietary supplement consumed by an NFL player and Winter Olympic athlete. We designed and oversaw the chemical testing program and used manufacturer samples as a comparison to the adulterated products.

Detection of Dietary Supplement Ingredients in Food

Full Description

Gradient evaluated three ingredients to determine if they were Old Dietary Ingredients (ODIs) or New Dietary Ingredients (NDIs) by conducting comprehensive searches of multiple databases and sources of marketing, industry, scientific, and regulatory literature. In addition, Gradient researched the presence of the chemicals in food and worked with a laboratory to develop a testing program to detect the supplements in food.

Toxicity Evaluation of a Fish Oil Supplement

Full Description

Gradient evaluated the arsenic content in fish oil capsules. We reviewed existing data for the product, designed and implemented a testing program to speciate arsenic, and evaluated the potential human health risks from ingesting the supplement. We compared the arsenic intake from the fish oil capsules to established applicable guidance levels.

Experts

Leslie A. Beyer Read Bio

A. Dallas Wait Read Bio