Regulatory News In Brief

FDA fires warning shot on Breathable Foods’ “inhalable caffeine”; agency guidance advises against phthalate excipients in drugs; pandemic adverse event reporting guidance finalized; Globe All Wellness recall of tainted supplements is insufficient; more Regulatory News In Brief.

FDA fires warning shot on “inhalable caffeine”

FDA warns Breathable Foods Inc. that its AeroShot product is not a dietary supplement as the firm claims and questions the product’s safety in a March 5 letter. Cambridge, Mass.-based Breathable Foods promotes the AeroShot canister’s “inhalable caffeine” that users can “puff in” anytime. But, FDA notes, supplements must be ingested and “the epiglottis in the throat keeps the process of inhalation and ingestion mutually exclusive.” Therefore, an inhalable product cannot be a supplement, the agency says. FDA also requests data on the safety of inhaling caffeine through the lungs and evidence of the product’s safe use in children. AeroShot’s website says the product’s caffeine powder comprises particles too large to enter the lungs. Sen. Chuck Schumer, D-N.Y., originally raised concern about AeroShot being marketed to teens as a “party enhancer” to be used with alcohol, and FDA echoes that concern (Also see "In Brief" - Pink Sheet, 27 Feb, 2012.).

Agency advises against phthalate excipients in drugs

OTC drugs and other products regulated by the Center for Drug Evaluation and Research should not be made with certain endocrine-disrupting phthalates, FDA advises the industry. A draft guidance published March 1 says dibutyl phthalate and di(2-ethylhexyl) phthalate are developmental and reproductive toxicants in lab animals, and manufacturers should use safer alternatives as excipients in their products. Phthalates, some of which are safe, appear in some drugs as an enteric coating plasticizer. France’s National Assembly voted in 2011 to ban phthalates in consumer products, though the measure has not been enacted (Also see "France Advances Phthalate & Paraben Ban With National Assembly Vote" - HBW Insight, 16 May, 2011.).

Pandemic AER guidance finalized

FDA leaves largely unchanged its guidance document on adverse event reporting for regulated products during an influenza pandemic. The final guidance published Feb. 23 follows a previous iteration released in early 2011, which itself revised a 2008 draft guidance (Also see "In Brief" - Pink Sheet, 17 Jan, 2011.). As in the earlier versions, FDA still expects manufacturers, packers and distributors of OTC drugs and dietary supplements to submit serious AERs to the agency within 15 business days or store them if necessary during a pandemic.

Recall insufficient for tainted supplements

Even though Globe All Wellness LLC recalled lots of “SlimXtreme” and “ViaXtreme” that included undeclared active pharmaceutical ingredients, FDA warns the Hollywood, Fla., company in a Feb. 6 letter to correct other related violations within 15 days. The agency notes that the weight-loss and sexual enhancement products are unapproved new drugs because they include the undeclared ingredients sibutramine and sildenafil, respectively. Further, testimonials about the products make drug claims and they fail to adequately warn consumers about their risks, FDA says. Globe All Wellness, also known as Global Wellness, recalled the same products in 2011 when FDA found they contained drug ingredients (Also see "Regulatory News In Brief" - Pink Sheet, 27 Jun, 2011.).

Melatonin inappropriate in foods

FDA continues to pursue firms that inappropriately market conventional foods as supplements to get around more restrictive food additive regulations. The agency warns Revolt Distribution in a Dec. 8 letter that Wownie Relaxation Cookie and Slowtivate Relaxation Drink products are not dietary supplements because they are represented as conventional food through their shape, size and descriptive terms. In addition, the firm’s use of a Nutrition Facts label on the drink suggests it knows the product is not a supplement. As foods, the products cannot include melatonin, which is an unapproved food additive. FDA earlier warned Baked World that melatonin-laced brownies are not supplements after Sen. Dick Durbin, D-Ill., sent the agency a letter voicing concerns about the product (Also see "In Brief" - Pink Sheet, 8 Aug, 2011.).

Royal Domains warned on nutrient claims

Claims by Royal Domains that Nature’s Pearl Premium Muscadine Grape Seed may inhibit cancer, counter type 2 diabetes and inhibit a leading cause of gastritis make the product an unapproved new drug, FDA says in a Jan. 6 warning letter. The product also is misbranded because it claims to be certified by FDA, which the agency does not do. Additionally, it claims a level of nutrient content that is undefined by FDA and fails to meet the requirements to use “antioxidant” on its label, the agency says.

Off-odor Gerber formula pulled from market

Gerber Products Co.proactively retrieves a batch of Good Start Gentle powdered infant formula after consumers reported an off odor from the product, which in some cases led to spit-up and gastrointestinal complaints. A release posted March 8 by FDA says the formula from batch GXP1684 in a 23.2-ounce plastic package poses no health or safety risk. Gerber, a Nestle SA subsidiary, is offering replacement product to consumers who bought the affected formula.