- Consumer products (personal care items, sports and recreation products, toys, household products, outdoor products)
Consumer products touch everyone’s lives. However, the exposure to both known constituents and unintentional contaminants from these products can be responsible for deaths, injuries and property damage. An area of consumer product safety assessment that has grown in importance is the area of nanotechnology. Nanotechnology has resulted in products such as stain- and wrinkle-resistant clothing, self-cleaning windows, glare-reducing and fog-resistant coatings for eyeglasses and windshields, and improved cosmetics and sunscreens. However, very little attention is devoted to assessment of health risks to humans or to the ecosystem. From a scientific perspective, there is the unsettled issue of "size matters" with respect to toxicity. The toxicology of nanoparticles is poorly understood and there is no regulatory requirement to test nanoparticles for health, safety and environmental impacts. Spherix staff has the expertise to assist with the strategy and execution of novel approaches to evaluate safety to workers and consumers from exposure to all consumer products, including those incorporating nanotechnology.
- Food Industry Practice (all areas of science and regulation affecting the food industry, including U.S. and EU regulation of food ingredients and packaging materials, labeling, advertising and promotion of food products and food enforcement)
Ingredient Approval:
Provides strategic, legal, regulatory and scientific support necessary for:- Generally recognized as safe self-determinations and notifications
- Food and color additive petitions
- Notifications for new dietary ingredients for dietary supplements
Food Contact Substances (paper and plastic packaging, active packaging):
The Food and Drug Administration Modernization Act of 1997 (FDAMA) established a food contact notification process as the primary means by which the Food and Drug Administration (FDA) regulates food additives that are food contact substances (FCSs). A FCS is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the use is not intended to have any technical effect in the food. Spherix prepares food contact notifications, and can assist the client with fulfilling the data needs to complete the chemistry, use, intended technical effect, migration testing, consumer exposure, safety, and comprehensive toxicological profile sections of the food contact notification.Food Labeling and Advertising:
Assist with all aspects of label claim support:- Nutrition labeling
- Health claims
- Significant Scientific Agreement
- Qualified
- Nutrient content claims
- Structure/Function Claims
- FDA label claim investigations
- Advertising substantiation
- Federal Trade Commission investigations
- Federal Trade Commission enforcement actions.
- Generally recognized as safe self-determinations and notifications
- Dietary supplements (foods that claim beneficial health effects and are subject to The U.S. Dietary Supplement Health and Education Act (DSHEA) of 1996 as a regulatory framework)
Dietary supplements are filling the consumer need for foods that help maintain good health. They are consumed for their beneficial health effects rather than, or in addition to, their nutritional contributions. Spherix staff has the expertise and experience needed to review and evaluate both the safety and efficacy of these types of products which is critical to the successful marketing and regulatory strategy for these products.
- Food ingredients (GRAS ingredients or food additives for functional foods, nutraceuticals, medical foods, infant formulas)
Food ingredients are used in a variety of products, including conventional foods, foods for special dietary use (medical foods), functional foods, and infant formulas. Spherix can provide both the strategic regulatory and scientific support necessary to obtain approval for and successfully market food ingredients that are regulated as a direct food additive or a GRAS ingredient. Our staff have prepared over fifty GRAS determinations of new and novel food ingredients including bioactive ingredients, macronutrients, fermentation products, and bioengineered foods.
- Health Claim or Structure/Function Claim Substantiation
Spherix staff can identify and screen candidate ingredients against agreed-upon criteria to assist companies in evaluating bioactive compounds for potential to serve as a functional food or dietary supplement ingredients. Characterization of identified studies for use in support of health claims can follow the hierarchy for study design recommended by the U.S. Food and Drug Administration for review of information when evaluating relationships between nutrients, food components, and ingredients and disease, risk factors for disease, or biomarkers (end points) of disease.
- Pesticides (Bactericides, Baits, Fungicides, Genetically Modified Organisms or Biological Pesticides, Herbicides, Insecticides, Lures, Rodenticides, Repellents)
Spherix assists clients with the fulfilling data needs and submitting an application package to EPA for all categories of pesticides: antimicrobials, biopesticides and conventional. The three processes share the same application materials, but there are differing data requirements and review policies that registrants must take into account in their submittal. Spherix can advise clients on the appropriate regulatory path and submission requirements.
- Pharmaceuticals, biologics and medical devices
Spherix staff of provides both regulatory and scientific support for all aspects of the U.S. Food and Drug Administration’s (FDA) drug approval process as well as the medical device approval process. This support includes preparing and reviewing protocols for animal (preclinical) testing and summarizing results; preparing and reviewing protocols for clinical (human) trials; assessing the health risks to humans from contaminants or excipients; preparing INDs and NDAs; serving as the client's technical contact with FDA scientists; and participating as the client’s representative in meetings with the FDA.
For more information, please contact us at info@spherix.com.