FDA has less confidence than the Natural Products Association that consumers can accurately measure small amounts of powdered caffeine, a question raised in warnings that five firms’ products are adulterated due to misleading labeling.

Serving sizes such as 200mg, equal to one-sixteenth of a teaspoon, indicated on the product labels “cannot be accurately measured using common household measuring tools. Many consumers do not have a scale that is sufficiently precise to accurately measure such a small amount,” FDA officials state in the letters published Sept. 1 (see table below).

In a statement, FDA’s Center for Food Safety and Applied Nutrition said safe quantities of powdered caffeine “can be nearly impossible to measure accurately with common kitchen measuring tools” and teaspoons and other volume measures “are not precise enough to calculate how many milligrams of caffeine are in the serving size.”

NPA, however, asked FDA for evidence that the absence of appropriate measuring devices is preventing consumers from using bulk powdered caffeine products according to the labeled serving sizes.

In an email to FDA’s Division of Dietary Supplement Programs, NPA CEO Daniel Fabricant said “the ability to weigh out 1/16th and 1/32nd of a teaspoon is commonplace in conventional culinary arts.”

“Does the agency have empirical evidence that consumers have restricted access to such tools and will substitute with alternative measuring devices to support [FDA’s warning] that the product is unsafe per the accurate labeled conditions of use?” Fabricant said.

Food and drug law attorney Ricardo Carvajal expects little pushback from manufacturers about the warnings because FDA focused its enforcement narrowly, similar to its 2010 action to halt marketing of energy drinks containing alcohol Also see "Four Alcoholic Energy Drink Warnings Should Shake Up The Market – FDA" - Pink Sheet, 29 November, 2010..

“I’m hard pressed to think of other dietary ingredients that have a similar toxicity profile and are distributed in the same manner,” said Carvajal, a director at Hyman, Phelps & McNamara PC in Washington.

Warnings that parse measurements stated on product labels, though, probably surprise some in the industry, he added. “It’s creative – and a reminder that FDA will find some way to go after products that rouse its concern.”

The United Natural Products Alliance and the Council for Responsible Nutrition, on the other hand, back FDA’s enforcement on powdered caffeine products. UNPA adopted a no-sale policy for bulk powdered caffeine as a membership condition in February ([A#05150406004]).

UNPA also recommended that bulk powdered caffeine not be advertised, sold or marketed as a supplement or exhibited at trade shows until an FDA final determination on safety and labeling. With the warning letters, “It appears that FDA has indeed made that determination,” said UNPA President Loren Israelsen in an email.

CRN also has updated its voluntary guidelines for caffeine-containing products with restraints against the sale and marketing of pure powdered caffeine, but not to limit marketing or sales of pure powdered caffeine in bulk form in business-to-business transactions.

“We have advised that our companies – and we hope the industry will follow suit – should not sell or market pure powdered caffeine in bulk form directly to consumers. We hope the companies receiving the warning letters will take these concerns seriously, and if not, we look to FDA to take the next steps under the law,” said Rend Al-Mondhiry, CRN’s regulatory counsel, in an email.

Extra Measurements Stirred In

Each warning letter states that CFSAN in August reviewed labels for products purchased online.

CFSAN Office of Compliance Director William Correll submitted the warnings because the products “present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, according to the letters.

CFSAN faults several of the firms for including on labels measurement information that does not apply to usage of the products. Several product labels include information on the milligram equivalents to one-eighth and one-quarter teaspoons even though the serving size is one-sixteenth of a teaspoon.

Those labels appear “to suggest that consumers may use a one-sixteenth teaspoon (and perhaps a 1/8 teaspoon or a 1/4 teaspoon) to measure a serving of 50 milligrams to 200 milligrams,” and the additional “suggested conditions of use present a significant or unreasonable risk of illness or injury,” according to the letters.

The warnings are the first since FDA in July 2014 published a consumer alert advising against the use of powdered caffeine after the deaths of two teenagers were reported as linked to use of the ingredient, which is sold as a supplement ([A#05140728011]).

Industry stakeholders were concerned that FDA’s warning against powdered caffeine use could reignite legislative efforts to more tightly regulate the ingredient. Potential changes could include requiring additional warnings, age restrictions on sales or other regulations that limit how firms can use caffeine and market products containing the ingredient.

While not imposing a new standard for product labeling, the warning letters spark concern at NPA over FDA potentially limiting caffeine volume in dietary supplements.

Fabricant said “it can be inferred from the letters that the agency considers one-sixteenth of a teaspoon of caffeine to present an unreasonable risk of illness or injury per the labeling” and asked for clarification.

FDA warns powered caffeine firms that their products “present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”

Firm

Product / Package Size

Serving Size On Label

Bridge City LLC , Portland, Ore.

Caffeine Anhydrous Natural Coffee Bean, 1kg to 25kg packages; Caffeine Powder (Synthetic Anhydrous) 10kg and 25kg.

“As a dietary supplement, take 50 to 200 mg up to three times daily. Use an accurate milligram scale for measurement.”

Hard Eight Nutrition LLC , Henderson, Nev.

Caffeine Powder, 100g to 25kg packages.

"As a dietary supplement, take 50 mg to 200 mg (1/16 tsp) up to three times daily."

(in table form) “U.S. Standard Measuring Spoons,” Spoon Size (level): 1/16 teaspoon, 1/8 teaspoon, 1/4 teaspoon; milligrams: 189, 378, 756.

Kreativ Health Inc. dba Natural Food Supplements, Conoga Park, Calif.

Sunshine Valley Caffeine Powder, package size N/A.

"As a dietary supplement, take 50 to 200 mg up to three times daily. Use a milligram scale for accurate measurement."

Purebulk Inc. , Roseburg, Ore.

Caffeine Powder (Synthetic), 25g to 25kg packages.

“Serving Size: 200 milligrams Servings Per Container: about 125”; describes 200 mg as a “rounded 1/32 tsp” and states that an “accurate measurement of caffeine powder…may be performed with a digital gram weight scale precise to 0.01 grams (10mg) or better.”

SPN LLC dba Smartpowders, Graham, N.C.

Caffeine Anhydrous, 400g package.

“Serving Size: 200mg

Servings per container: 2000

¼ Teaspoon: 574mg”

FDA Takes The Measure Of Bulk Caffeine In Warnings About Labels

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