Adroit Market Research - Industry Insights

Dietary supplement is a term mainly used for describing any product containing a component or ingredients especially aimed at supplementing a diet. Moreover, dietary supplementary products are available in several forms including herbal supplements, vitamin & mineral products as well as specific nutritional products like protein powders and tablets. Components in supplement products consist of vitamins & minerals, herbs as well as several other elements like enzymes, amino acids & metabolites in concentrated forms. This white paper objects at underlining facts about certain health concerns and misinterpreted regulatory policies by manufactures followed by their potential solut

Dietary supplement is a term mainly used for describing any product containing a component or ingredients especially aimed at supplementing a diet. Moreover, dietary supplementary products are available in several forms including herbal supplements, vitamin & mineral products as well as specific nutritional products like protein powders and tablets. Components in supplement products consist of vitamins & minerals, herbs as well as several other elements like enzymes, amino acids & metabolites in concentrated forms. This white paper objects at underlining facts about certain health concerns and misinterpreted regulatory policies by manufactures followed by their potential solutions.

In spite of the fact that customers’ are extensively accepting their budding health and nutritional benefits, products of dietary supplement been sold in the United States are not needed to be tested individually for safety or efficiency before going to the market. However, industrialists are especially accountable for assessing the safety as well as suitable labeling of their products that meets with the compliance policies of FDA. Though a number of dietary supplements available in market are safe, still FDA receives thousands of consumer complaints and adverse reaction reports every year in connection with dietary supplements.

In addition, there has been a number of independent surveys that provides analysis about the possibly major health as well as safety concerns associated with dietary supplements available in the market. Some of such concerns have been highlighted below:

• Composition of dietary supplements—a real integral composition of dietary supplements commonly diverges from the composition listed on a product’s label. For instance, a Canadian scientists analyzed 44 unlike herbal products that are available in the markets of United States and Canada. At the end of his study he concluded that approx. 32% of testers subject to the assessment of DNA as they did not contain any ingredient listed on the label, whereas approx. 59% of testers consisted of herbs that was completely omitted from the label.
• Listed ingredients Quantity—also, amount of listed ingredients is likely to vary extensively from the quantities specified over the label of the product, revealing the consumers to precarious levels of some ingredients. For instance, a researchers in his study highlights a related case of severe selenium toxicity in above 200 patients due to a liquefied dietary supplement that consisted of about 200 times the selenium concentration listed over the label of that supplement.
• Ingredients Safety—sometimes these dietary supplements have got poisonous metals along with other unsafe ingredients. In an extensively exposed study, scientists resolute that about more than 20% of ayurveda medicines that are been sold in the United States by the means of e-commerce consisted of, noticeable amount of lead, mercury or even arsenic in surplus level that was more than the standards of daily intake.
• False health Claims— there are certain manufacturers that are selling dietary supplements by making exaggerated claims in terms of health benefits. For instance, a company based in Arizona (a southwestern U.S. state) was advertising a liquid homeopathic drops as a weight-loss supplement that the organization falsely claimed might support the users in rapid and major weight loss.

Regulatory Challenges of Dietary Supplements Manufacturers

FDA standardizes both ended dietary supplement products as well as components in dietary supplements in the United States. Dietary supplements are actually outside the stringent oversighted allowable drugs & medical products. Rather these have been categorized as a food product type and need to comply with the regulations propagated under the DSHEA (federal Dietary Supplement Health and Education Act) of 1994 and several other latest regulation.

Under present FDA regulations, producers along with suppliers are directly accountable for assessing the safety & labeling of their merchandises before they are being promoted for sale as well as ban the sale of products that are adulterated and misbranded. While dietary supplement merchandises are already subjected to comparatively confine regulatory oversight, still the producers, distributors & suppliers of the products are liable for meeting several requirements by FDA.

Some of those FDA requirements are defined as follows:

Registration of services: Irrespective of the sited location, producers of dietary supplements need to register their services with FDA. This particular requirement is applicable to any facility that is manufacturing, processing or involved in packing of foodstuff for the consumption of human or animal in U.S. Besides, all the registered food services are subject to timely assessment by the personnel’s of FDA. Moreover, the registration can be suspended if in case FDA determines that a particular facility is accountable for a food product that is possibly instigating severe health concerns or death to humans/ animals. However, registration of the services must be renewed every new year.

Necessitates Labeling: Also, FDA regulates dietary supplement labels, package insertions plus other related information that might complement a dietary supplement. As far as labeling is concerned FDA wants the dietary supplement product labels to include at least the following information:

• List of all the ingredients included in the dietary supplement product.
• A registered name of the product also known as statement of identity
• Quantity of the supplement product in the package
• Labeling of the nutrition
• A registered phone number and mailing address

Process for notifying New Dietary Components

Ingredients used in any dietary supplement advertised in the United States in 1994 or later are called “New dietary components.” Producers as well as suppliers who desire to sell dietary supplement products with such ingredients need to first provide FDA with a premarket notice within 75 days or before the product is broadcasted for interstate trade. This notice for a dietary supplement product involving a new dietary ingredient requires certain information regarding the ingredient, accompanied by the evidences or other related information signifying the safety of the product after adding the new ingredient.