Nutraceutical Testing

Beauty From Within. . . Is Currently Extremely In

“Beauty from within” is the current catchphrase for dietary supplements meant to improve skin health. The skin clearly shows the connection between health and beauty. Smooth skin without redness or dry and rough areas is considered beautiful.

There is no question that healthy eating, active lifestyles, and a balanced diet can dramatically improve our appearance, and many brands aim to capitalize on this concept.

Regulation and Claim Validation

Nutraceuticals have become popular as a way to help promote health and wellness, inside and out.  They’re largely unregulated, and exist in the same category as food additives and dietary supplements by the FDA.

It is important to note that nutritional supplement claims are categorized by the FDA into three major categories:

Health Claims and FDA-Qualified Benefit Claims

This category represents the are the most common goal for label claims and marketing materials.

As instructed by the FDA, these claims should be inclusive of a statement on the label that advises “These statements haven’t been assessed by the Food & Drug Administration.  This product isn’t intended in preventing, cure, diagnose, or treat any disease.”

When you see that statement above on a product label, it’s nothing to necessarily fear or worry about: it just means that the manufacturer is following the posted regulatory guidance.

Health claims officially describe the relationship between a food substance and some form of reduced risk of disease or a reduction in a health-related condition.  These claims are regulated by three main vehicles:

• FDA Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Dietary Supplements
• The 1997 Food and Drug Administration Modernization Act (FDAMA)
• The 1990 Nutrition Labeling and Education Act (NLEA)

Most beauty from within claims tends to try and “straddle” the regulations above, and describe changes in conditions like hydration and visual reduction in dryness or the appearance of fine lines and wrinkles.

It is extremely important to note that regardless of the ingredients, claims alone can be enough to trigger an FDA investigation, and all product label claims must be supported by robust clinical data.

As an FDA Registered Clinical Laboratory, Validated Claim Support can design and implement placebo-controlled, double-blind nutritional supplement studies that are based off of prior published and accepted scientific research.

Nutrient Content Claims

These claims represent the physical ingredients and their relative concentrations or percentages in a product, and are outside the scope of what Validated Claim Support can assist with.

Please consult with your legal team about Nutrient Content Claims and applicable regulatory guidelines.

Structure and Function Claims

Structure and Function Claims are closely related to general health claims, but they tend to be slightly more general in their scope.

Some examples as provided by the FDA include “Calcium creates strong bones,” “Antioxidants maintain the integrity of cells,” and “Fiber maintains regularity of bowel.”

These claims are not “pre-approved” by the FDA, however, they are widely used and based on years of clinical research and data.  Unlike with skincare claims, there is a direct bridge between active ingredients and final label claims when it comes to vitamins and minerals and approved FDA nutritional ingredients. 

The Beauty from Within Claims Market

Consumer awareness of the connection between beauty and overall health continues to get stronger every year.  In today’s world, beauty is more of a full-body, health-conscious concept and not just something cosmetic and superficial.

Companies today are looking to create multifunctional products that influence both physical and mental well-being, and for most people, the concept of physical beauty is related to a balanced and healthy diet.

Natural beauty is also making a very solid comeback, and in many cultures, less makeup and the healthy, physically fit look are definitely in.  Nutritional supplements and vitamins can help to ensure that even without cosmetic enhancements and makeup consumers are looking their best whether they’re at the gym or out on the town.

It is imperative that no matter what the trends in the market may be that as a manufacturer, you follow all of the posted guidelines in your respective jurisdiction.

Overstepping Claims and Enforcement

It’s hard to get through a month without seeing a major manufacturer being sued or challenged for their marketing materials and label claims.  This is particularly true in the nutritional world.

In the last decade, protein powders, nutritional drinks, and vitamin supplements have exploded, and the ability for them to get to market directly to the consumer is more desirable than ever.

Some brands capitalize on the rapid move-to-market by skimping on toxicology, safety, and clinical claims.

It is important to note that as with skincare studies, it is not enough to base your label claims on past research alone.  It is risky to assume that because you have a particular FDA-approved ingredient, that the FDA or other regulatory bodies will let you say whatever you want about it.

Please consult with your legal and marketing teams before making any individual nutritional claims.

Nutraceutical and Supplement Validation Techniques

• Before & After Photography
• Biophysical Instrumentation
• Expert Clinical Grading
• Subjective Questionnaires/User Trials

Nutraceutical and Supplement Related Claims

• Beauty from within
• Helps keep skin hydrated
• Helps to support a more youthful appearance
• Increases collagen