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What's the Deal with the FDA?

The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm's compliance with regulations and the Food, Drug and Cosmetic Act.

Take a peek  – does it say “Nutrition Facts” or “Supplement Facts”... What difference does one word make? It’s actually kind of a big deal. Check it out...

Energy Drink is a term used to refer to beverages and supplements. However, these are two different categories of products with their own sets of regulations. Both beverages and supplements are regulated by the FDA.

Food & Beverage vs. Supplement Regulations:

Beverages are considered conventional foods; supplements are not food or beverages or drugs. Ingredients added to FOOD must be approved food additives or be classified as (GRAS) - (see our HEALTHY ALTERNATIVE page).

Ingredients added to SUPPLEMENTS must meet these two requirements: (1) The ingredient must be a dietary ingredient and (2) if the ingredient was not sold in the US as a dietary supplement before October 15, 1994, the manufacturer must file a special report that notifies the FDA of the intention to use this ingredient and must provide scientific evidence of its safety

A “dietary ingredient” is defined by the Dietary Supplement Health and Education Act (DSHEA) as a vitamin, mineral, herb/botanical, amino acid, metabolite/extract or some other substance intended to boost (or supplement) the level people already consume.

Why October 15, 1994?

Because that’s when DSHEA was signed into law. Before this time, dietary supplements were subject to the same regulatory requirements as food products. Now, dietary supplements are just “under the umbrella” of food, which is why their safety is monitored by the FDA’s Center for FOOD Safety and Applied Nutrition (CFSAN).

Food Labels vs. Supplement Labels

Food products and supplements are both required to list all the components added to make the final formula. Food labels are required to list the ingredients by descending order, meaning the ingredient used the most comes first in the list while the ingredients that make up less than 2% of the total formula go last. Only certain ingredients (Calories, Total Fat, vitamins A and C - to name a few) are required to be itemized with the amounts, other ingredients are only required to be mentioned in the list of ingredients. Supplements are required to list every ingredient in the formula, either in the “Supplement Facts” panel or in the “Other Ingredients” section.

NOTE: the supplement label may group “proprietary blends” and list only the total amount of the blend, as long as there are no ingredients added to the supplement that are omitted entirely from the label.

Special Circumstances with Caffeine:  caffeine is only required on the food label when it is added, not inherent—this is why dark chocolate does not mention caffeine in the ingredients list, but it is included within the product. When it is added, the word “caffeine” must appear in the ingredients list, but the amount of caffeine is not required to be listed.

Food Safety vs. Supplement Safety

The FDA limited the amount of caffeine in cola-type drinks to 0.02% (71 mg per 12 oz serving). Neither coffee nor energy drinks are held to this limit. 

Well Guess What?

We at HYPED ENERGY know better. We aim to provide complete transparency and dedicated customer focus. We want YOU as a life-long customer. We are building a community, not a commodity. Are you with us?

Find out about cGMP Facilities here